Biotech Newcomer to Purchase Sanofi Plant in Allston

Posted by ISPE Boston
On February 19, 2021

National Resilience, a biotech newcomer launched in November 2020 and headquartered in Boston and San Diego, is poised to purchase the Sanofi bio-manufacturing plant in Allston. According to its website, Resilience “will actively invest in developing powerful new technologies to manufacture complex medicines that are defining the future of therapeutics, including cell and gene therapies, […]

Curevac and GSK to Co-Develop Next Gen mRNA COVID Vaccine

Posted by ISPE Boston
On February 19, 2021

Curevac and GlaxoSmithKline will partner to jointly develop next generation mRNA vaccines for COVID-19 with the potential for a multi-valent approach to address multiple emerging variants in one vaccine. GSK will also support the manufacture of up to 100 million doses of CureVac’s first generation COVID-19 vaccine candidate CVnCoV in 2021. Through this new exclusive […]

Selecting Your Off-site GMP BioPharma Storage Provider

Posted by Michael Davanzo
On February 19, 2021

Abstract Off-site storage of GMP biological and pharmaceutical products and medical devices is a critical resource for biopharmaceutical companies, contract manufacturing organizations (CMOs), and contract development and manufacturing organizations (CDMOs) facing storage and overflow issues. There are many critical factors to consider when selecting an off-site GMP storage provider. Among the most crucial factors to […]

CONTINUUS Pharmaceuticals Wins Government Contract to Manufacture Critical Meds

Posted by ISPE Boston
On February 11, 2021

Woburn-based CONTINUUS Pharmaceuticals has won a $69.3 million U.S. government contract to facilitate domestic production of three medicines used to treat critically ill patients, including those with COVID-19. “…In addition to streamlining continuous, environmentally friendly, and cost-efficient production of these medicines, this contract will help us build a state-of-the-art facility that will address urgent pharmaceutical supply chain […]

Biogen’s Alzheimer’s Drug Candidate Gets FDA Review Extension

Posted by ISPE Boston
On February 11, 2021

Biogen and Eisai have announced that the FDA has extended the review period by three months for the Biologics License Application (BLA) for aducanumab, an investigational treatment for Alzheimer’s disease. The new action date is June 7, 2021. If approved, aducanumab would be the first treatment to meaningfully change the course of the disease for […]

Thermo Fisher to Acquire Rapid PCR-Based Test For COVID-19

Posted by ISPE Boston
On February 11, 2021

Thermo Fisher Scientific has announced plans to acquire Mesa Biotech, a privately held molecular diagnostic company, for approximately $450 million in cash. Under the terms of the agreement, Thermo Fisher will pay up to an additional $100 million in cash upon the completion of certain milestones following the close of the transaction which is expected to take place in Q1 2021. […]

Chapter Member Anniversaries: February 2021

Posted by ISPE Boston
On February 8, 2021

Please congratulate the following members celebrating milestone anniversaries in February 2021. Their dedication to ISPE, the Boston Area Chapter and the industry is applauded! Over Twenty Years John P. Alleruzzo, Kenneth A. Bradley, Pfizer Inc James M. Crotty, MSFM, Takeda Dr. Eric S. Good, ProPharma Group Michael D. Matton, New England Sales Inc Dr. Richard […]

Welcome New Members January 2021!

Posted by ISPE Boston
On February 8, 2021

We would like to introduce the Members who joined ISPE in January 2021, welcome them to the Chapter and encourage them (and all of our members) to take advantage of the many professional development, networking and information resources available through ISPE. Fellow ISPE members are a terrific resource for help with everyday professional challenges. And […]

Single Use Technologies Webinar Kicks Off the New Year

Posted by Caren Jenkins
On February 4, 2021

The Boston Area Chapter hosted the first educational program of 2021 on January 21 – a webinar on Single Use Technology presented by Process Engineer Alejandro Kaiser moderated by Educational Program Committee Co-Chair Aaron Hubbell. Alejandro is a dynamic speaker able to take complex subjects considered “a bit dry” and transform them into engaging, informative […]

How the Ethnocultural Diversity & Inclusion Initiative Came to Be

Posted by Eric Felz
On January 27, 2021

Let’s be honest. Conversations about racial diversity, equity and inclusion are tough. Lots of times, they are challenging and uncomfortable. However, over the last several years, the need for these conversations has become increasingly evident. Particularly, over the past year, I have seen a great deal of tension around racial inequality with demonstrations and protests, some peaceful, focusing on the collaboration […]

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