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Boston Area Chapter Current Year Events List

Event
ISPE Student Development Committee Meeting
Date: 3 January 2017

This is a regular meeting for the Student Development Committee.  If you have any questions, please call the office at 781-647-4773.

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ISPE Educational Programs Planning Meeting
Date: 4 January 2017

This is a regular meeting for the EPC Committee.  If you have any questions, please call the office at 781-647-4773.

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ISPE Product Show Committee Meeting
Date: 9 January 2017

This is a regular meeting for the Product Show Committee.  If you have any questions, please call the office at 781-647-4773.

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ISPE Board of Directors Meeting
Date: 10 January 2017

This is a regular meeting for the Board of Directors.  If you have any questions, please call the office at 781-647-4773.

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ISPE Design Review and Optimization of SIP and CIP Processes
Date: 19 January 2017

PRESENTATIONS
John Hyde: http://www.ispeboston.org/files/cip_optimization_-_hyde.pdf

Joe Povenski: http://www.ispeboston.org/files/evaluating_sip_and_sterilization_methods_-_povenski.pdf


Framingham State University

D. Justin McCarthy Campus Center - Forum Auditorium
100 State Street
Framingham, MA 01701

EVENT INFORMATION: 
You are invited to attend a live program on optimized process systems design strategies and microbial preventative measures.  The program will be held at Framingham State University’s D. Justin McCarthy Campus Center – Forum Auditorium in Framingham, MA (venue kindly provided by the Framingham State University, Biotechnology Program).  The event will feature a networking reception with appetizers and refreshments, and a live Q&A session after the presentation. Register now for this great program!

Current Best Practices for Biopharma Process Systems Design Strategies for Optimized CIP Performance (John Hyde). John will present a number of recent design reviews providing case studies to illustrate the concepts.

Prevention of microbial ingress within biologics process (Joe Povenski). Prevention of microbial ingress within any biologics process offers numerous challenges.  If any measure or control is ignored or discounted, the frequency of a contamination event can increase exponentially. Any risk to the process should be acknowledged and remediated when possible, even when considered quantitatively low. Evaluating sterilization methods in response to such an event is critical and a key to the overall success of the investigation. The goal of the presentation is to review sterilization principles and how to identify sterilization deficiencies within the overall investigation roadmap. 

WHO SHOULD ATTEND: 
Validation and Facility Engineers, Quality Assurance Professionals, QC Microbiology and Contamination Control Professionals, Capital Projects Managers, Manufacturing Science and Technology Engineers.

SPEAKERS:
John Hyde, Chairman and Founder, Hyde Engineering + Consulting, Inc.
John Hyde founded Hyde Engineering + Consulting, Inc. in 1993 and specializing in process engineering, process and equipment validation, and compliance consulting for biopharmaceutical and pharmaceutical manufacturers. Hyde Engineering + Consulting, Inc. have operations in the United States, Europe, Singapore and India.

For nearly two years prior to the formation of Hyde Engineering + Consulting, Inc., John was Senior Project Engineer with Synergen, a biopharmaceutical research and manufacturing company located in Boulder, CO. His work at Synergen included design, start-up and validation of key process systems and the overall responsibility for the cleaning validation programs for the firm's large scale and clinical manufacturing facilities.  From 1982 to 1992, John was Manager, Process Design with Seiberling Associates, Inc., an engineering firm specializing in the design and start-up of biopharmaceutical, food and beverage process systems and the application of CIP technology.

Joe Povenski, Process Specialist, CRB
With 18 years of experience from the owner’s side ranging from process development to licensed commercial manufacturing, Joe hopes to give an end user, customer focused perspective when response to a microbial contamination event is warranted.  Having facilitated several microbial ingress investigations in the past, those experiences have lead Joe to a comprehensive understanding of all aspects of critical process design and microbial preventative measures.  

MEETING MANAGERS:
Robert Lucas, CAI
Gennady Malin, Sanofi Genzyme
Rami Mitri, Spectra Automation Ltd.

REGISTRATION FEES:
Before 1/12/2017: 
Member $50.00  
Young Professional Members $20.00 
Non-Member $95.00**
ISPE Student Members: FREE

After 1/12/2017: 
Member: $60.00
Young Professional Members $30.00 
Non-Member: $115.00**
ISPE Student Members: FREE
**Non-members may only attend one program as a non-member**

Thank you to our Sponsor:  

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ISPE RE-SHOWING: Design Review and Optimization of SIP and CIP Processes
Date: 26 January 2017

Pre-Registration is now closed. Walk-ins will be accepted on-site.

RE-SHOWING OF 1/19/2017 PROGRAM AT


Redhook Ale Brewery - Alemaker's Hall
1 Redhook Way, Portsmouth, NH 03801

AND WPI Biomanufacturing Education and Training Center at Gateway Park
50 Prescott Street, Worcester, MA 01605

AND Providence Marriott Downtown
1 Orms Street, Providence, RI 02904

EVENT INFORMATION: 
Join us on January 26, 2017 at the Redhook Ale Brewery in Portsmouth, NH; the WPI BETC at Gateway Park in Worcester, MA; or the Providence Marriott Downtown Hotel for a re-showing of the program recorded at Framingham State University. A networking reception, including refreshments and appetizers, will be hosted before the presentation at each location.

PROGRAM SUMMARY: 
Current Best Practices for Biopharma Process Systems Design Strategies for Optimized CIP Performance (John Hyde). John will present a number of recent design reviews providing case studies to illustrate the concepts. 

Prevention of microbial ingress within biologics process (Joe Povenski). Prevention of microbial ingress within any biologics process offers numerous challenges.  If any measure or control is ignored or discounted, the frequency of a contamination event can increase exponentially. Any risk to the process should be acknowledged and remediated when possible, even when considered quantitatively low. Evaluating sterilization methods in response to such an event is critical and a key to the overall success of the investigation. The goal of the presentation is to review sterilization principles and how to identify sterilization deficiencies within the overall investigation roadmap. 

WHO SHOULD ATTEND: 
Validation and Facility Engineers, Quality Assurance Professionals, QC Microbiology and Contamination Control Professionals, Capital Projects Managers, Manufacturing Science and Technology Engineers.

SPEAKERS:
John Hyde, Chairman and Founder, Hyde Engineering + Consulting, Inc.
John Hyde founded Hyde Engineering + Consulting, Inc. in 1993 and specializing in process engineering, process and equipment validation, and compliance consulting for biopharmaceutical and pharmaceutical manufacturers. Hyde Engineering + Consulting, Inc. have operations in the United States, Europe, Singapore and India. For nearly two years prior to the formation of Hyde Engineering + Consulting, Inc., John was Senior Project Engineer with Synergen, a biopharmaceutical research and manufacturing company located in Boulder, CO.

His work at Synergen included design, start-up and validation of key process systems and the overall responsibility for the cleaning validation programs for the firm's large scale and clinical manufacturing facilities.  From 1982 to 1992, John was Manager, Process Design with Seiberling Associates, Inc., an engineering firm specializing in the design and start-up of biopharmaceutical, food and beverage process systems and the application of CIP technology.

Joe Povenski, Process Specialist, CRB
With 18 years of experience from the owner’s side ranging from process development to licensed commercial manufacturing, Joe hopes to give an end user, customer focused perspective when response to a microbial contamination event is warranted.  Having facilitated several microbial ingress investigations in the past, those experiences have lead Joe to a comprehensive understanding of all aspects of critical process design and microbial preventative measures.  

REGISTRATION FEES:
Member FREE
Young Professional Members FREE
Non-Member FREE
ISPE Student Members: FREE

MEETING MANAGERS:
Robert Lucas, CAI
Gennady Malin, Sanofi Genzyme
Rami Mitri, Spectra Automation Ltd.

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ISPE New Year's Social
Date: 26 January 2017

Pre-registration is now closed.
Walk-ins will be accepted onsite.
If you have any questions contact the office at 781-647-4773.

 

Thursday, January 26, 2017
6:00 – 9:00pm
Blazing Paddles at Game On
82 Lansdowne Street, Boston, MA 02215

Start the New Year off by joining the Boston Area Chapter of ISPE for a night of Ping Pong and Baseball!! There will be prizes awarded for the Ping Pong tournament (sign up early).  The batting cage at Fenway Park is available for all to take a few swings. Sign up now and show off your skills on the table and in the cage!

Light fare and cash bar will be provided.

Tournament Prizes and 50/50 Raffle to benefit ALS

Thank you to our Sponsors:


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ISPE Student Career Workshop
Date: 28 January 2017

Pre-Registration is now closed. Walk-ins will be accepted on-site.

If you will be graduating in 2017-2020, come to a workshop specifically designed to help you to hone your skills and improve your chances of getting that internship, co-op, or full time position in the Life Science Industry.

ISPE Boston has assembled a group of industry experts to help you:

Take Inventory of Yourself
Why you are unique

Get the Interview
Resume building
Effective cover letters

Get the Job
First Impressions
Interviewing Tips
What employers look for

Build Your Network
Why networks are important
Where do I begin?

Build Your Career Path
Short and long term planning

Learn from Industry Pros
Young Professionals
Seasoned Veterans
Entrepreneurs

COST/REGISTRATION

Free for ISPE Student Members. Including materials, lunch, and refreshments

Not an ISPE member? Join and attend.

Join ISPE here www.ispe.org/join-or-renew

WHEN

Saturday, January 28, 2017
10:00 AM – 5:00 PM
Doors open at 9:30AM

WHERE

Northeastern University
Egan Hall
Raytheon Amphitheater
End of Forsyth Street
Boston, MA 02120

Here is a map of Northeastern University

What to Bring

Your Questions!
Business Cards
Dress is Business Casual

Want more information? Contact us at office@ispeboston.org or call 781-647-4773

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ISPE Young Professionals Committee Meeting
Date: 31 January 2017

This is a regular meeting of the Young Professionals Committee.  If you have any questions, please call the office at 781-647-4773.

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ISPE Educational Programs Planning Meeting
Date: 1 February 2017

This is a regular meeting for the EPC Committee.  If you have any questions, please call the office at 781-647-4773.

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ISPE Product Show Committee Meeting
Date: 6 February 2017

This is a regular meeting for the Product Show Committee.  If you have any questions, please call the office at 781-647-4773.

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ISPE Student Development Committee Meeting
Date: 7 February 2017

This is a regular meeting for the Student Development Committee.  If you have any questions, please call the office at 781-647-4773.

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ISPE Board of Directors Meeting
Date: 7 February 2017

This is a regular meeting for the Board of Directors.  If you have any questions, please call the office at 781-647-4773.

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ISPE Young Professionals Bowling and Networking
Date: 8 February 2017

Pre-registration is closed. Walk-ins will be accepted onsite. If you have any questions contact the office at office@ISPEBoston.org or 781-647-4773.

Back by Popular Demand! Join the ISPE Boston Area Chapter Young Professionals at The Flatbread Company in Davis Square for an evening of pizza, beer, socializing, and candlepin bowling at the famous Sacco’s Bowl Haven! Enjoy a variety of wood-fired, clay oven flatbread pizzas (vegetarian options will be offered) and salad. Bowling shoes will be provided and a cash bar will be available.

Space is limited to 50 attendees, so please get your tickets before it’s too late!

Wednesday, February 8, 2017
7:00 PM - 9:00 PM

The Flatbread Company
45 Day Street, Somerville, MA 02144

Registration Fees:
Member: $20
Non-Member: $25
Student Member: FREE

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ISPE Shifting Paradigms in Pharmaceutical Water and Steam
Date: 16 February 2017

Registration is now closed.  Walk-ins are welcome.  If you have any questions, please contact (781) 647-4773 or office@ispeboston.org 

LOCATION:
Biogen – Building 8 Auditorium
225 Binney Street, Cambridge, MA 02142
(Entrance at Building 9, 300 Binney Street)

SCHEDULE:
Afternoon Registration and Networking Reception:     3:00 PM – 3:30 PM
Afternoon Presentation:                                       3:30 PM – 5:30 PM
Evening Session Registration:                                5:30 PM – 6:00 PM
Evening Networking Reception:                              5:30 PM – 6:30 PM
Evening Presentation:                                          6:30 PM – 8:30 PM

EVENT INFORMATION:
You are invited to attend a live program presented by ISPE’s Critical Utility Community of Practice on the Critical Utilities of Water and Steam Systems. The program will be held at Biogen in Cambridge (venue kindly provided by Biogen). The event will feature an afternoon educational session, networking reception with appetizers and refreshments, followed by an evening presentation. You are invited to attend either or both of the sessions for one low price. Register now for this great program!

PROGRAM SUMMARY: 
Afternoon Session: The Current State of the Art in Pharmaceutical Water Systems

This session focuses on two important areas in Pharmaceutical Water: changes to USP <1231> and the evolution of rapid microbiological detection techniques and their impact on the biopharm industry.

The US Pharmacopoeia recently updated its non-binding guidance <1231> for the pharmaceutical industry. This session reviews the changes and updates to this important USP guidance document.  Since USP <1231> is a living document, there will also be discussions about future revisions to this document, including some additional elemental monitoring requirements.

Recently, there have been advances in rapidly detecting bacteria present in pure water systems.  These technological advances could a have widespread and positive impact in the biopharm industry as detection times change from 3 days to a few minutes.  But technologies and detection limits vary and implementation of this new technology may pose challenges.  Come to this session for an overview of the technologies in use, how they work, and learn about implementing a rapid microbiological detection system in a regulated environment.


PRESENTED BY:
Brian Hagopian, CPIP, Clear Water Consulting, Inc.
Joe Manfredi, GMP Systems, Inc.

Evening Session: Sampling of Pharmaceutical Water and Steam Systems
Sampling of compendial water and steam systems is required to demonstrate compliance with established process parameters and specifications.  When any step of the sampling process isn’t done properly, errors may be introduced and misrepresentative data can cost companies thousands if not millions of dollars by creating costly and unnecessary investigations and corrective actions. Sampling is an involved and complicated process and there is very little guidance on sampling – until now.  ISPE has recently published The ISPE Good Practice Guide: Sampling for Pharmaceutical Water, Steam, and Process Gases, the first definitive guide to sampling.  The guide provides expert guidance on all aspects of sampling.  Attend this session to learn from contributing authors of the guide, who will highlight some of the content of the Sampling Guide.  The information contained in this session, coupled with the Sampling Guide itself will become an indispensable tool to all users and custodians of water, steam, and process gas systems.

PRESENTED BY:
Joe Manfredi, GMP Systems, Inc.
Brian Pochini, CPIP, Sanofi Genzyme

WHO SHOULD ATTEND?
This session will provide valuable information to engineering, design, facilities, manufacturing, quality, validation, and regulatory functions as well as anyone who wants to learn more about water and steam systems.

SPEAKER AND MODERATOR:

Brian Hagopian, CPIP, Clear Water Consulting, Inc.

Brianis a degreed chemist from Colgate University and is the President of Clear Water Consulting, Inc. Brian brings over 35 years of experience as a high purity water subject matter expert, consultant, trainer, educator, and expert troubleshooter. Brian is an instructor at Worcester Polytechnic Institute’s Biomanufacturing Education and Training Center and is a Massachusetts certified instructor offering courses for industrial wastewater operators.

Brian has been an ISPE member since 1992 and has been an integral part of the growth of the Boston Area Chapter.  In 2015, Brian became one of six people to have received the Hank Moes Lifetime Achievement Award for significant contributions to the Boston Area Chapter and the life sciences industry.  Brian currently leads the Boston Area Chapter’s Student Development Committee where student membership has grown five-fold over the past several years.  Brian has been a member of the ISPE Critical Utilities COP Steering Committee for the past four years and has just finished leading a team of over 20 industry experts in publishing the ISPE Good Practice Guide on Sampling of Pharmaceutical Water, Steam, and Process Gases, which was released in December, 2016

SPEAKERS:

Joe Manfredi, GMP Systems, Inc.

Joe Manfredi is the President of GMP Systems where he has spent over 30 years designing systems, overseeing fabrication and installation, troubleshooting, training and providing consulting services for many of the world’s major pharmaceutical manufacturers. 

Joe was instrumental in establishing the Pharmaceutical Engineering Masters of Science Program at the New Jersey Institute of Technology, where he developed and taught many of the core graduate program courses and served as Chair of their Pharmaceutical Engineering Advisory Committee.

Joe is a graduate of Newark College of Engineering.  His expertise includes all areas of liquid processing with a special emphasis on water and steam systems.  Joe is a leading instructor of orbital welding technology for pharma and provides seminars in operator certification, orbital weld inspection and equipment calibration and service.

Joe was named ISPE Member of the Year in 1991 and Newark College of Engineering Distinguished Alumnus in 2004.  Joe has been a long time member of the ISPE CU CoP steering committee and led the group of subject matter experts to produce the water chapter in the Sampling Guide.

Brian Pochini, CPIP, Sanofi Genzyme

Brian is a principal Engineer working in Sanofi Specialty Care Operations Engineering.  Brian attained his Bachelor’s Degree in Chemical Engineering from Worcester Polytechnic Institute, his MBA from Bentley University, and attained his CPIP Credential from ISPE in 2012.

Brian has 20 years of practical experience within the biotechnology, membrane manufacturing and custom chemical industries.  Brian’s current responsibilities encompass many functions including HVAC, Critical Utilities, Process Engineering, Instrumentation and Controls, and Facility Design where he works with cross functional teams for multiple capital projects.

Brian is a former member of the ISPE C+Q Steering Committee and is currently the Chair of the ISPE Critical Utility COP Steering Committee.  Brian led the team of experts in producing the steam chapter for the Sampling Guide. 

MEETING MANAGERS:
Jim Taylor, Lean Biologix
Brian Hagopian, Clear Water Consulting, Inc.

REGISTRATION FEES:
Before 2/9/2017: 
Member $50.00  
Young Professional Members $20.00 
Non-Member $95.00**
ISPE Student Members: FREE

After 2/9/2017: 
Member: $60.00
Young Professional Members $30.00 
Non-Member: $115.00**
ISPE Student Members: FREE
**Non-members may only attend one program as a non-member**

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ISPE RE-SHOWING: Shifting Paradigms in Pharmaceutical Water and Steam
Date: 23 February 2017

Pre-registration is now closed.  Walk ins will be accepted at all site.  For questions, please contact ISPE Boston's office at (781) 647-4773

RE-SHOWING OF 2/16/2017 PROGRAM AT

Redhook Ale Brewery - Tour Gallery
1 Redhook Way, Portsmouth, NH 03801

AND WPI Biomanufacturing Education and Training Center at Gateway Park
50 Prescott Street, Worcester, MA 01605

AND Crowne Plaza Hotel 
801 Greenwich Ave, Warwick, RI 02886

REGISTRATION FEES:
Member FREE
Young Professional Members FREE
Non-Member FREE
ISPE Student Members: FREE

EVENT INFORMATION:
Join us on February 23, 2017 at the Redhook Ale Brewery in Portsmouth, NH; the WPI BETC at Gateway Park in Worcester, MA; or a location in Providence TBD for a re-showing of the program recorded at Biogen on February 16th. A networking reception, including refreshments and appetizers, will be hosted before the presentation at each location.

PROGRAM SUMMARY: Sampling of Pharmaceutical Water and Steam Systems
Sampling of compendial water and steam systems is required to demonstrate compliance with established process parameters and specifications.  When any step of the sampling process isn’t done properly, errors may be introduced and misrepresentative data can cost companies thousands if not millions of dollars by creating costly and unnecessary investigations and corrective actions. Sampling is an involved and complicated process and there is very little guidance on sampling – until now.  ISPE has recently published The ISPE Good Practice Guide: Sampling for Pharmaceutical Water, Steam, and Process Gases, the first definitive guide to sampling.  The guide provides expert guidance on all aspects of sampling.  Attend this session to learn from contributing authors of the guide, who will highlight some of the content of the Sampling Guide.  The information contained in this session, coupled with the Sampling Guide itself will become an indispensable tool to all users and custodians of water, steam, and process gas systems. 

PRESENTED BY:
Joe Manfredi, GMP Systems, Inc.
Brian Pochini, CPIP, Sanofi Genzyme

*See biographies below

WHO SHOULD ATTEND?
This session will provide valuable information to engineering, design, facilities, manufacturing, quality, validation, and regulatory functions as well as anyone who wants to learn more about water and steam systems.

SPEAKERS:
Joe Manfredi, GMP Systems, Inc.
Joe Manfredi is the President of GMP Systems where he has spent over 30 years designing systems, overseeing fabrication and installation, troubleshooting, training and providing consulting services for many of the world’s major pharmaceutical manufacturers. 

Joe was instrumental in establishing the Pharmaceutical Engineering Masters of Science Program at the New Jersey Institute of Technology, where he developed and taught many of the core graduate program courses and served as Chair of their Pharmaceutical Engineering Advisory Committee.

Joe is a graduate of Newark College of Engineering.  His expertise includes all areas of liquid processing with a special emphasis on water and steam systems.  Joe is a leading instructor of orbital welding technology for pharma and provides seminars in operator certification, orbital weld inspection and equipment calibration and service.

Joe was named ISPE Member of the Year in 1991 and Newark College of Engineering Distinguished Alumnus in 2004.  Joe has been a long time member of the ISPE CU CoP steering committee and led the group of subject matter experts to produce the water chapter in the Sampling Guide

Brian Pochini, CPIP, Sanofi Genzyme
Brian is a principal Engineer working in Sanofi Specialty Care Operations Engineering.  Brian attained his Bachelor’s Degree in Chemical Engineering from Worcester Polytechnic Institute, his MBA from Bentley University, and attained his CPIP Credential from ISPE in 2012.

Brian has 20 years of practical experience within the biotechnology, membrane manufacturing and custom chemical industries.  Brian’s current responsibilities encompass many functions including HVAC, Critical Utilities, Process Engineering, Instrumentation and Controls, and Facility Design where he works with cross functional teams for multiple capital projects.

Brian is a former member of the ISPE C+Q Steering Committee and is currently the Chair of the ISPE Critical Utility COP Steering Committee.  Brian led the team of experts in producing the steam chapter for the Sampling Guide. 

MEETING MANAGERS:
Jim Taylor, Lean Biologix
Brian Hagopian, Clear Water Consulting, Inc

 

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ISPE Young Professionals Committee Meeting
Date: 28 February 2017

This is a regular meeting of the Young Professionals Committee.  If you have any questions, please call the office at 781-647-4773.

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ISPE Educational Programs Planning Meeting
Date: 1 March 2017

This is a regular meeting for the EPC Committee.  If you have any questions, please call the office at 781-647-4773.

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ISPE Annual Ski Trip
Date: 3 March 2017

Join ISPE for the Chapter's Annual Ski Trip on March 3, 2017 at Waterville Valley.  Space is Limited, so Don't Delay!

Price Includes: Bus ride up and back, full day adult lift ticket, lunch voucher, buffet dinner, and a lot of fun with fellow ISPE members!

Note: Books of 4 Tickets are available for $340.  If you would like to purchase a Book, please fill out the FLYER and email or fax it to office@ispeboston.org or 781-647-7222.

Bus Departures: 
6:00 AM: from Newton Marriott - Rt. 128
6:40 AM: from Chateau Restaurant - Andover, MA
7:40 AM: from LL Bean, Concord - NH

Bus Returns: 4:30 PM from the hill to all Departure Sites (Concord, Andover, Newton)

Thanks to our Ski Trip Sponsors: 

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ISPE Product Show Committee Meeting
Date: 6 March 2017

This is a regular meeting for the Product Show Committee.  If you have any questions, please call the office at 781-647-4773.

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ISPE Student Development Committee Meeting
Date: 7 March 2017

This is a regular meeting for the Student Development Committee.  If you have any questions, please call the office at 781-647-4773.

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ISPE Board of Directors Meeting
Date: 14 March 2017

This is a regular meeting for the Board of Directors.  If you have any questions, please call the office at 781-647-4773.

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ISPE Presents: Continuous Manufacturing of Biopharmaceuticals
Date: 16 March 2017

Takeda Pharmaceuticals
35 Landsdowne Street
Cambridge, MA 02139

SCHEDULE:

Registration and Networking Reception: 5:30 - 6:30 PM
Presentations: 6:30 - 8:30 PM
Q&A Session: 8:30 - 9:00 PM

EVENT INFORMATION:
Join us to learn about the latest developments in continuous manufacturing of biopharmaceuticals.  The event will feature a networking reception with hors d’oeuvres and refreshments including complimentary wine and beer. The main event includes three presentations followed by a panel discussion. Register now for this great program!

PROGRAM SUMMARY:
Continuous Biopharmaceutical Manufacturing: Challenges & Possibilities (Andre Walker, CPIP)
Continuous processing has transformed industries from petrochemicals to steel.  Endless case studies highlight how early adopters thrived while laggards, often leading firms in the industry, withered.  However, in the highly regulated space of the biopharmaceutical industry, impediments to adoption of this technology range from simple lack of vision and leadership, as well as significant economic and cultural factors.
Do these challenges conspire to make continuous manufacturing of biologics impractical, uneconomical, and simply too risky?  Andre’s presentation will address the hype, the key concerns, and present a possible future of continuous manufacturing of biologics.

Protein A Resin Lifetime Study: Evaluation of Protein A Resin Performance with a Model based approach in continuous capture (Ketki Behere)
Increased product yield at reduced cost and time is the driving force of many bio-manufacturing process improvements. Within the mAb platform, Protein A has played a critical role as an affinity moiety in traditional bind-and-elute (batch) chromatography.  As product demand and upstream titer continue to increase, continuous Protein A chromatography is being explored to keep up.
Although Protein A resins possess unique stability, degradation of resin particles takes place under continuous chromatographic conditions - mainly caused by caustic during the sanitization phase of chromatography. A modified shrinking core model (MSCM) has been employed to describe the mechanism and rate at which the degradation occurs. The kinetic model utilizes semi-empirical parameters estimated from breakthrough experiments for three distinct resins. This study proved the utility and functionality of the designed model, which can be built upon to design effective cleaning strategies.  In turn this should improve resin performance, and extend resin lifetime for continuous downstream processing.

Transforming Downstream Processing through Multi-Column Chromatography (Kathleen Mihlbachler)
Implementation of continuous processing in bio-manufacturing requires rethinking process chromatography and its equipment design. After years of development and many successes, continuously operating technologies are becoming part of the downstream processing (DSP) platform. This presentation will focus on multi-column technology including:

Basics of multi-column chromatography
Design requirements: Equipment and Automation
Optimization: Reducing the complexity in process and system design
Regulatory aspects and Performance Verification (PV)
Current developments and future trends

WHO SHOULD ATTEND?
Engineers, Scientists, and Quality Personnel who are interested in learning more about continuous manufacturing.

SPEAKERS:
Andre Walker, CPIP, Principal, Andre Walker Consulting, LLC
Andre Walker has over 30 years of experience providing engineering and technical support for manufacturing operations in consumer products, medical devices, and biotechnology. His biologics industry experience includes Director of Engineering and Manufacturing Sciences at several bio-manufacturing facilities ranging in scale from 2000 to 15,000 liters. He has held leadership roles in commercial cGMP facilities in the US and Denmark, and has served as Chairman of ISPE’s Board of Directors. Andre holds the Certified Pharmaceutical Industry Professional (CPIP) credential and is a recipient of the Hank Moes Lifetime Achievement Award.

Ketki Behere, PhD Candidate, Chemical Engineering, UMass Lowell
Ketki Behere’s research focusses on characterization of Protein A resin in downstream chromatography for purification of antibodies. She has worked at Lonza Biologics, Portsmouth as a co-op student in the Manufacturing Sciences and Technology (MSAT) group and as a Research Associate at Lonza Biologics, Hopkinton in the Downstream Process Development (PD) group. Previously she worked as Production executive in bio-manufacturing at Reliance Life Sciences (RIL), India. She has a Bachelor of Engineering degree in Biotechnology Engineering from Shivaji University, India.

Dr. Kathleen Mihlbachler, Global Director of Separation Development, LEWA Bioprocess
Dr. Mihlbachler has 20 years’ experiences in the field of process chromatography. In her current position as Global Director of Separation Development, she is responsible for the establishment of innovative technologies at LEWA Bioprocess, in particular for continuous processing applications in pharma. She is the principal designer/developer of the EcoPrime Twin platform by successfully leading the tech transfer of the ChromaCon’s CaptureSMB technology to the process scale. Dr. Mihlbachler has also been involved in hands-on training of engineers and scientists, as well as advisory roles for bachelor and PhD theses.  Dr. Mihlbachler presents technical and scientific results at international meetings and in peer-reviewed publications.
Prior to joining LEWA Bioprocess, Dr. Mihlbachler was Sr. Researcher for 10 years in the pharmaceutical industry. She was involved in the development and scale-up of purification/separation processes for numerous biologic compounds, peptides and proteins, implementing continuous processes at BMS, Eli Lilly and Pfizer. She has taught undergraduate courses in chemical and biomedical engineering at New Jersey Institute of Technology.  She also lead process chromatographic workshops (Prep Symposium) for more than 10 years.

MEETING MANAGERS:
Dan Pratt, Takeda Pharmaceuticals
Jack Campion, The Hart Companies

REGISTRATION FEES
Before 3/9/2017:
Member $50.00  
Young Professional Members $20.00 
Non-Member $95.00
ISPE Student Members: FREE

After 3/9/2017:
Member: $60.00
Young Professional Members $30.00 
Non-Member: $115.00
ISPE Student Members: FREE

Thank you to our Sponsor:

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ISPE RE-SHOWING: Continuous Manufacturing
Date: 23 March 2017

Save the Date!


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ISPE Young Professionals Committee Meeting
Date: 28 March 2017

This is a regular meeting of the Young Professionals Committee.  If you have any questions, please call the office at 781-647-4773.

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ISPE Product Show Committee Meeting
Date: 3 April 2017

This is a regular meeting for the Product Show Committee.  If you have any questions, please call the office at 781-647-4773.

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ISPE Student Development Committee Meeting
Date: 4 April 2017

This is a regular meeting for the Student Development Committee.  If you have any questions, please call the office at 781-647-4773.

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ISPE Board of Directors Meeting
Date: 4 April 2017

This is a regular meeting for the Board of Directors.  If you have any questions, please call the office at 781-647-4773.

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ISPE Educational Programs Planning Meeting
Date: 5 April 2017

This is a regular meeting for the EPC Committee.  If you have any questions, please call the office at 781-647-4773.

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ISPE 2017 Student Poster Contest
Date: 13 April 2017

Want to Show Off Your Work and Win $500.00? Register to Compete in the:

ISPE Boston Area Chapter
ANNUAL STUDENT POSTER CONTEST
on Thursday, April 13, 2017

Two winning student posters, one each from the graduate and undergraduate categories will receive a $500 cash prize and a FREE TRIP to compete at the International Student Poster Competition at ISPE’s Annual Meeting in San Diego, CA on October 28-November 1, 2017. Winners of the International competition receive cash awards and have the opportunity to publish their materials in ISPE's Pharmaceutical Engineering magazine, as well as other Chapter/Affiliate publications. 

Pre-Registration is required and you must be a member of the Boston Area Chapter of ISPE to participate.  Join ISPE at www.ispe.org/join-or-renew .

Cost:
Free

Location:
WPI’s Biomanufacturing Education and Training Center (BETC)
50 Prescott Street, Worcester, MA

Registration Deadline:
April 6, 2017 at noon

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ISPE Good Practice Guide to Single Use
Date: 13 April 2017

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ISPE Young Professionals Committee Meeting
Date: 25 April 2017

This is a regular meeting of the Young Professionals Committee.  If you have any questions, please call the office at 781-647-4773.

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ISPE Brainstorming Session For 2018 Educational Programming
Date: 26 April 2017

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ISPE 25th Anniversary Gala
Date: 27 April 2017

Join your friends, colleagues, and fellow chapter members in commemorating the 25th Anniversary of the ISPE Boston Area Chapter with a gala cocktail reception and sit-down dinner on Thursday, April 27, 2017 at the InterContinental Hotel in Boston. Celebrate this milestone by enjoying keynote speakers, entertainment, and socializing with friends and colleagues. Don’t miss this quarter century party!

Attendee Registration Opening Soon!

Sponsor Registration NOW OPEN!

Click here to browse & register for sponsorship opportunities

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ISPE Product Show Committee Meeting
Date: 1 May 2017

This is a regular meeting for the Product Show Committee.  If you have any questions, please call the office at 781-647-4773.

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ISPE Student Development Committee Meeting
Date: 2 May 2017

This is a regular meeting for the Student Development Committee.  If you have any questions, please call the office at 781-647-4773.

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ISPE Educational Programs Planning Meeting
Date: 3 May 2017

This is a regular meeting for the EPC Committee.  If you have any questions, please call the office at 781-647-4773.

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ISPE Spring Golf Tournament
Date: 8 May 2017

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ISPE Board of Directors Meeting
Date: 9 May 2017

This is a regular meeting for the Board of Directors.  If you have any questions, please call the office at 781-647-4773.

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ISPE Validation
Date: 17 May 2017

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ISPE Young Professionals Committee Meeting
Date: 23 May 2017

This is a regular meeting of the Young Professionals Committee.  If you have any questions, please call the office at 781-647-4773.

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ISPE Product Show Committee Meeting
Date: 5 June 2017

This is a regular meeting for the Product Show Committee.  If you have any questions, please call the office at 781-647-4773.

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ISPE Student Development Committee Meeting
Date: 6 June 2017

This is a regular meeting for the Student Development Committee.  If you have any questions, please call the office at 781-647-4773.

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ISPE Educational Programs Planning Meeting
Date: 7 June 2017

This is a regular meeting for the EPC Committee.  If you have any questions, please call the office at 781-647-4773.

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ISPE Board of Directors Meeting
Date: 13 June 2017

This is a regular meeting for the Board of Directors.  If you have any questions, please call the office at 781-647-4773.

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ISPE BEER
Date: 15 June 2017

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ISPE Summer Social and Volunteer Appreciation Night
Date: 22 June 2017

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ISPE Young Professionals Committee Meeting
Date: 27 June 2017

This is a regular meeting of the Young Professionals Committee.  If you have any questions, please call the office at 781-647-4773.

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ISPE Product Show Committee Meeting
Date: 10 July 2017

This is a regular meeting for the Product Show Committee.  If you have any questions, please call the office at 781-647-4773.

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ISPE Board of Directors Meeting
Date: 11 July 2017

This is a regular meeting for the Board of Directors.  If you have any questions, please call the office at 781-647-4773.

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ISPE Educational Programs 2018 Season Planning Meeting
Date: 19 July 2017

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ISPE Young Professionals Committee Meeting
Date: 25 July 2017

This is a regular meeting of the Young Professionals Committee.  If you have any questions, please call the office at 781-647-4773.

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ISPE Educational Programs Planning Meeting
Date: 2 August 2017

This is a regular meeting for the EPC Committee.  If you have any questions, please call the office at 781-647-4773.

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ISPE Product Show Committee Meeting
Date: 7 August 2017

This is a regular meeting for the Product Show Committee.  If you have any questions, please call the office at 781-647-4773.

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ISPE Board of Directors Meeting
Date: 8 August 2017

This is a regular meeting for the Board of Directors.  If you have any questions, please call the office at 781-647-4773.

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ISPE Board of Directors Meeting
Date: 9 August 2017

This is a regular meeting for the Board of Directors.  If you have any questions, please call the office at 781-647-4773.

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ISPE Summer Golf Tournament
Date: 21 August 2017

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ISPE Product Show Committee Meeting
Date: 28 August 2017

This is a regular meeting for the Product Show Committee.  If you have any questions, please call the office at 781-647-4773.

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ISPE Young Professionals Committee Meeting
Date: 29 August 2017

This is a regular meeting of the Young Professionals Committee.  If you have any questions, please call the office at 781-647-4773.

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ISPE Educational Programs Planning Meeting
Date: 6 September 2017

This is a regular meeting for the EPC Committee.  If you have any questions, please call the office at 781-647-4773.

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ISPE Product Show Committee Meeting
Date: 11 September 2017

This is a regular meeting for the Product Show Committee.  If you have any questions, please call the office at 781-647-4773.

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ISPE Board of Directors Meeting
Date: 12 September 2017

This is a regular meeting for the Board of Directors.  If you have any questions, please call the office at 781-647-4773.

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ISPE Focused Trends from the FDA
Date: 14 September 2017

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ISPE Product Show Committee Meeting
Date: 25 September 2017

This is a regular meeting for the Product Show Committee.  If you have any questions, please call the office at 781-647-4773.

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ISPE Young Professionals Committee Meeting
Date: 26 September 2017

This is a regular meeting of the Young Professionals Committee.  If you have any questions, please call the office at 781-647-4773.

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ISPE Annual Product Show and Educational Seminars
Date: 4 October 2017

Please note that this is the planned date for the 26th Annual Product Show!

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ISPE Board of Directors Meeting
Date: 10 October 2017

This is a regular meeting for the Board of Directors.  If you have any questions, please call the office at 781-647-4773.

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ISPE Educational Programs Planning Meeting
Date: 11 October 2017

This is a regular meeting for the EPC Committee.  If you have any questions, please call the office at 781-647-4773.

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ISPE Young Professionals Committee Meeting
Date: 24 October 2017

This is a regular meeting of the Young Professionals Committee.  If you have any questions, please call the office at 781-647-4773.

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ISPE Fall Social
Date: 26 October 2017

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ISPE Annual Meeting
Date: 29 October 2017 - 1 November 2017

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ISPE Educational Programs Planning Meeting
Date: 1 November 2017

This is a regular meeting for the EPC Committee.  If you have any questions, please call the office at 781-647-4773.

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ISPE Product Show Committee Meeting
Date: 6 November 2017

This is a regular meeting for the Product Show Committee.  If you have any questions, please call the office at 781-647-4773.

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ISPE How to Deal with Difficult People
Date: 9 November 2017

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ISPE Board of Directors Meeting
Date: 14 November 2017

This is a regular meeting for the Board of Directors.  If you have any questions, please call the office at 781-647-4773.

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ISPE Young Professionals Committee Meeting
Date: 28 November 2017

This is a regular meeting of the Young Professionals Committee.  If you have any questions, please call the office at 781-647-4773.

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ISPE Product Show Committee Meeting
Date: 4 December 2017

This is a regular meeting for the Product Show Committee.  If you have any questions, please call the office at 781-647-4773.

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ISPE Educational Programs Planning Meeting
Date: 6 December 2017

This is a regular meeting for the EPC Committee.  If you have any questions, please call the office at 781-647-4773.

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ISPE Single Use
Date: 7 December 2017

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ISPE Board of Directors Meeting
Date: 12 December 2017

This is a regular meeting for the Board of Directors.  If you have any questions, please call the office at 781-647-4773.

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ISPE 2018 Student Poster Contest
Date: 12 April 2018

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ISPE Annual Product Show and Educational Seminars
Date: 26 September 2018

Please note that this is the planned date for the 27th Annual Product Show!

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ISPE Annual Product Show and Educational Seminars
Date: 18 September 2019

Please note that this is the planned date for the 28th Annual Product Show!

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ISPE Annual Product Show and Educational Seminars
Date: 16 September 2020

Please note that this is the planned date for the 29th Annual Product Show!

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ISPE Annual Product Show and Educational Seminars
Date: 15 September 2021

Please note that this is the planned date for the 30th Annual Product Show!

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Page last updated: 23 November 2015