Please note: the Spring Conference has been canceled due to concerns regarding the spread of COVID-19. The Board of Directors will be monitoring the situation and will reschedule this program as soon as is possible. If you have any questions please contact the office at firstname.lastname@example.org or (781) 647-4773.
annual ISPE Boston Area Chapter Spring Conference is pleased to present a
program focused on lessons learned and best practices. The topics covered in
this conference will delve into the key ideas, strategies and implementation
processes that attendees can utilize in order to achieve the greatest value at
their own facilities. Attend concurrent educational sessions that expand upon
the keynote presentation topics.
Networking: Capitalize on opportunities
to meet and connect with clients, develop new associations, and solidify
existing partnerships. Meet with members and associates of the Boston area ISPE
Vendors: Meet industry-leading
solution providers and explore how their products and services can help you
achieve project success.
Student Poster Contest:
View the entries to the ISPE Boston Area Chapter Student Poster Contest. Learn
about and discuss the research findings of local ISPE students at the
undergraduate and graduate level.
Chapter Awards Presentation: Join us as we formally recognize and celebrate achievements within the ISPE Boston Area Chapter.
PROGRAM SCHEDULE: 11:30 AM - Registration & Networking 12:00 PM - Luncheon Keynote 1:30 - 5:00 PM - Concurrent Educational Sessions 5:00 PM - Networking Reception and Awards Presentation
WHO SHOULD ATTEND: This program will appeal to a wide variety of industry personas including Process & Automation Engineers, Quality Assurance, and Operations Professionals. Individuals or organizations involved in life sciences should attend as it shall provide insights into new ways of thinking about existing challenges in life science manufacturing. The expert assembly of speakers shall provide new approaches to streamlining manufacturing processes and cost savings.
PRESENTATION ABSTRACTS: Keynote: Eric Schnake, Plasma OpU Lead, Capital Projects & Portfolio, Takeda Pharmaceuticals Takeda’s Georgia Manufacturing Facility – Sharing the Top Lessons Learned and Success Factors of a Greenfield Project Every year millions of patients depend upon plasma-derived therapies obtained through plasma fractionation processes. Takeda’s new 1.1 million square feet state-of-the-art Plasma Protein Manufacturing facility is the cornerstone of a global strategy ensuring patients world-wide have access to its medications. Takeda relied on a global team of experts and innovative risk management strategies to successfully plan, design, and construct a facility meeting current production requirements, that is also expandable for future needs. The Project’s award-winning safety program was a top priority, leading to the 2015 CURT Construction Industry Safety Excellence Award by the Construction Users Roundtable. The Education Session will explore many of the project success factors and lessons learned from such a complex initiative and share these with the participants.
Gilad Langer, Manufacturing Practice Lead, Tulip & PJ Geldenhuis, Sr. Solutions Engineer, Vertex Pharmaceuticals via JMA Engineering Solutions A view into Pharma 4.0 technologies to support human activity The promise of productivity gains from digital technologies don’t have to involve lengthy and complex implementation. There is a lot that can be gained by simply digitizing manual processes. This can be exemplified by how a leading pharmaceutical manufacturer used a no-code Manufacturing App Platform to guide employees through a complex line clearance and setup process. The elimination of paper-based SOPs for visual, interactive work instructions shortened the process from two weeks to two days – an 80% reduction in time. Join the session to learn more.
Charlie Maher, Global Director, Process and Manufacturing Technology, CAI Quality by Design (QbD) in the era of Cell and Gene Therapy - Taking it to the Next Level Since the publication of ICH-8 in 2006, Quality by Design (QbD) has been employed by the life science industry to improve pharmaceutical product quality, reduce regulatory risk and enhance patient access to novel products. With the rise of cell and gene therapies, the use of QbD is even more important given the pace of innovation, the compression of the product development lifecycle, challenges in characterizing product and process, and rapid institutional learning by regulatory bodies. This presentation will explore these drivers and highlight examples of how the disciplined use of QbD can enhance the product quality, success in regulatory approvals, reduced direct and indirect product lifecycle costs and improved regulatory flexibility for post-approval changes for cell and gene therapy products.
Forrest Brown, Engineering Services Manager, Sequence & Emily Petrelis, Validation Projects & Systems Leader, Thermo Fisher Scientific Efficient Gene Therapy Facility Start-Up: Best Practices and Common Pitfalls How will you ensure your next gene therapy start-up is executed compliantly AND efficiently? Taking a new gene therapy facility/expansion from construction to production presents many challenges. While each project is unique, avoiding common pitfalls can significantly reduce risk to schedule and budget. This presentation will focus on optimizing the start-up process by utilizing a risk-based approach to focus on common areas of primary importance.
Manufacturer case studies will be provided with lessons learned, including an opportunity for questions from the audience. This presentation is intended for anyone challenged with delivering increased gene-therapy manufacturing capacity who also wants to provide the most efficient and effective solution possible.
William Deckert, Global Consult, CAI Cell & Gene Therapy Facilities – How to renovate to save time and money A very detailed discussion about how existing facilities can be renovated into Cell & Gene Therapy manufacturing suites with less cost and a shorter schedule. This will result in getting products to market quicker and creating more ROI for investors and for manufacturing companies. With 700 new products hitting the market within the next 24 months, it is critical to create manufacturing spaces that can produce these products quickly and safely.
Pietro Perrone, Automatic Process Engineer, GE Healthcare Advanced Automation for the Flexible Manufacture of Therapeutics Improvements in biopharmaceutical productivity and flexibility are achieved when unit operations in the production train perform in concert with each other. The architecture of the automation that supports the bioprocess operation defines the design of a flexible and effective manufacturing operation. Developing standardized automation modules enhances the applicability to multiple unit operations and improves the speed of implementation into manufacturing operations by applying software that is verified across multiple platforms. This results in fast and cost-effective implementations for the manufacturers of therapeutics.
Connected manufacturing is to seamlessly link unit operations via both physical and digital connections throughout the process. Connected manufacturing integrates an overarching layer of automation across multiple steps in the bioprocess train extending from upstream to downstream. Aligned with the physical connections, the digital connections coordinate the individual unit operations with each other and minimize operator intervention.
This presentation highlights innovative production methods and technologies that enable a competitive and sustainable biopharmaceutical product supply. Key factors for an industry that aims to maximize productivity, flexibility and quality in the manufacture of biopharmaceutical products.
Elizabeth Rivera, Technical Services Manager, STERIS Stage 3 Maintenance of a Cleaning Validation Program The recent shift from traditional cleaning validation to a 3-staged cleaning life cycle approach emphasizes the requirement for scientifically sound decisions in the design, qualification, and monitoring of a cleaning process. The main purpose of the third validation stage is continuous assurance that the cleaning procedure is performing as expected and remains in a state of control for the life of the product(s) being manufactured. As suggested in the FDA Process Validation Guidance, to accomplish continuous assurance a system (or systems) is essential for detecting unplanned departures from the validated process. Implementing a system to evaluate the performance of the cleaning process includes collecting and interpreting cleaning data that allows detection of undesired variability.
When a process shows undesired variability actions must be taken to correct, anticipate, and prevent problems so the process remains in control. An ongoing program to collect and analyze product and process data that relate to cleaning acceptance criteria (and hence product quality) must be established. The information collected should verify that the critical cleaning attributes are being controlled throughout the process. Several concepts are discussed in the presentation provide guidance on the various ways to provide a high level of assurance that a cleaning process remains validated and in control such as Periodic Review, monitoring and data trending, preventive maintenance, non-routine soils and cleaning beyond validated, personnel retraining, change control procedures, deviations, OOS, among others.
Lindsay Smart, Managing Director, ZETA US Inc. Single-Use Vs Stainless Steel – Are Hybrid Facilities the Best of Both Worlds? The pharmaceutical industry is constantly facing severe time and cost pressures. Currently, in order to be able to react to new developments in the sector, as quickly as possible, the focus is ever increasingly centered on time-to-market as well as modular, highly flexible production concepts for new biopharmaceutical products. During the planning phase for so-called fast-track projects, single-use technologies (SUT) are also becoming increasingly more important. It is suggested, in search of the best possible solution, the industry should jointly rely more on hybrid solutions and customized single-use systems.
SUT is often manufacturer specific and can often only be used in a limited way. In contrast, customized stainless-steel solutions, which do not have these disadvantages, can tend to be less flexible and require time-consuming cleaning and sterilization processes. State-of-the-art hybrid solutions are based on well-designed engineering concepts, combining SUT with high-end stainless-steel components. Therefore, benefits of both system types can be realized: low investment costs, high flexibility and shorter set-up times of SUT are combined with durable stainless-steel components, guaranteeing the highest level of automation and process safety, integrity and reproducibility. This presentation will detail: 1) How current assemblies can be customized and interconnected with highly sophisticated cross-functionality from a mechanical and automation perspective; 2) The advantages of next level single-use systems from recent case studies, which will show how dance floor concepts improve process clarity and ergonomics, operator safety and simplify maintenance and 3) Supplier agnostic concepts showing how a stainless steel backbone can handle generic single use bioreactors and other single-use assemblies to optimize facility design and layout.