Pharmaceutical Technology Editors

PharmaLex, a provider of specialized services for the pharma, biotech, and medtech industries, announced on Feb. 24, 2021 that it has completed its acquisition of ERA Consulting, a consulting firm that provides product development and regulatory support.

Through the acquisition, PharmaLex will expand its capabilities in the biopharma sector while enhancing its global market reach with a new location in Australia, PharmaLex said in a company press release.

“The ERA team is excited about being part of the PharmaLex Group, as this enables us to provide additional support to our clients through the breadth of PharmaLex’s services,” said Andrew Moore, chief operating officer, ERA, in the press release.

“The addition of ERA to the PharmaLex Group represents a key milestone in the company’s strategic orientation as solution provider for the biotech sector. ERA’s extensive expertise will add significant value to further build our biopharma solutions,” added Dr. Thomas Dobmeyer, CEO, PharmaLex, in the press release. “Expanding our global network into Australia is also an important step and will help us strengthen our Asia-Pacific reach.”

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Through the acquisition, PharmaLex will expand its capabilities in the biopharma sector while enhancing its global market reach with a new location in Australia.

PharmaLex Completes Acquisition of ERA Consulting

Bristol Myers Squibb announced on Feb. 23, 2021 that construction has begun on its new cell therapy manufacturing facility in Devens, MA.

Located on the company’s current 89-acre Devens campus, the 244,000-ft2 facility will have the ability to handle the quick ramp-up of capacity for clinical and commercial cell therapy products, Bristol Myers Squibb said in a company press release. The new facility is part of Bristol Myers Squibb’s investment into the clinical and commercial manufacturing of cell therapies for patients with aggressive hematological cancers.

“Bristol Myers Squibb is at the forefront of manufacturing innovations, and we are proud that our new cell therapy facility in the Boston area will include many next generation technologies and the latest integrated digital systems,” said Ann Lee, PhD, head, Cell Therapy Development and Operations, Bristol Myers Squibb, in the press release.

The new facility is part of Bristol Myers Squibb’s investment into the clinical and commercial manufacturing of cell therapies for patients with aggressive hematological cancers.

Bristol Myers Squibb to Open New Cell Therapy Facility in Massachusetts

Catalent announced on Feb. 23, 2021 that it has acquired Delphi Genetics, a Belgium-based plasmid DNA (pDNA) cell and gene therapy contract development and manufacturing organization.

Through the acquisition, Catalent will establish pDNA development and manufacturing services at its Rockville, MD facility and will gain Delphi’s team of R&D and genetic engineering scientists, technicians, and regulatory specialists, Catalent said in a company press release. Additionally, Catalent will acquire Delphi’s proprietary STABY technology, an antibiotic-free selection system for plasmid and protein production in 

“We are absolutely thrilled to team up with Catalent and, by combining with the companies it has already established in Belgium, create a European Center of Excellence in Cell and Gene Therapy,” said François Blondel, chairman of the board and CEO of Delphi Genetics, in the press release. “We believe Catalent will immediately benefit from our expertise and the recent investments we have made in CGMP [current good manufacturing practice] capacity.”

“Cell and gene therapy production is complex, and most developers prefer to use experienced partners with an integrated offering across the supply chain. Having integrated pDNA supply is a critical component for the fast and efficient production of viral vectors,” added Manja Boerman, PhD, president, Catalent Cell & Gene Therapy, in the press release. “By providing these capabilities in both Europe and the [United States], where the vast majority of genetic therapy companies are based, we will help our partners improve processes and reduce timelines as they bring their life-changing therapies to patients.”

Through the acquisition, Catalent will establish pDNA development and manufacturing services at its Rockville, MD, facility and will gain Delphi’s team of R&D and genetic engineering scientists, technicians, and regulatory specialists.

Catalent to Acquire Delphi Genetics to Expand Plasmid DNA Capabilities 

Pfizer and BioNTech announced on Feb. 19, 2021 that they have submitted new data to FDA that shows the stability of their COVID-19 vaccine when stored at -25 to -15 °C; the companies propose an update to the vaccine’s Emergency Use Authorization prescribing information, allowing for the vials to be stored at the standard freezer temperatures for up to two weeks.

Currently, the vaccine must be stored in an ultra-cold freezer at temperatures between -80 and -60 ºC, where it can remain for up to six months. If the label change is approved, the vaccine can be stored for two weeks at -25 to -15 °C. Stability data were collected on batches manufactured over the past nine months of COVID-19 vaccine development.

“We have been continuously performing stability studies to support the production of the vaccine at commercial scale, with the goal of making the vaccine as accessible as possible for healthcare providers and people across the US and around the world,” said Albert Bourla, chairman and CEO, Pfizer, in the press release. “We appreciate our ongoing collaboration with the FDA and CDC as we work to ensure our vaccine can be shipped and stored under increasingly flexible conditions. If approved, this new storage option would offer pharmacies and vaccination centers greater flexibility in how they manage their vaccine supply.”

“Our top priority was to quickly develop a safe and effective vaccine and make it available to the most vulnerable people in the world in order to save lives. At the same time, we have continuously collected data that could enable storage at around -20 °C. The data submitted may facilitate the handling of our vaccine in pharmacies and provide vaccination centers an even greater flexibility,” added Ugur Sahin, CEO and co-founder of BioNTech, in the press release. “We will continue to leverage our expertise to develop potential new formulations that could make our vaccine even easier to transport and use.”

New data shows that the COVID-19 vaccines can be stored at standard freezer temperatures for up to two weeks.

Pfizer and BioNTech Submit New Vaccine Stability Data to FDA

 on Feb. 22, 2021 that is has issued a suite of guidance documents to address the emergence of variants of SARS-CoV-2. The guidance documents include an update to the October 2020 guidance on Emergency Use Authorization (EUA) for vaccines to prevent COVID-19, guidance on the impact of the variants on monoclonal antibody (mAb) products and other treatments, and a guidance the impact of the variants on COVID-19 tests.

Emergency Use Authorization for Vaccines to Prevent COVID-19

, offers recommendations to vaccine developers regarding virus variants, including developers who already received EUA for their vaccine. The agency stated, in a press release, that FDA-authorized vaccines are effective against the current strains of SARS-CoV-2, but it may be necessary to tailor vaccines should a new variant emerge in the United States that is “moderately or fully resistant to the antibody response elicited by the current generation of COVID-19 vaccines”.

 that gives recommendations for developers of SARS-CoV-2-targeting mAbs including approaches to the generation of non-clinical, clinical, and chemistry, manufacturing, and controls data to support an EUA for an mAb product effective against variants. FDA also issued a 

 that provides recommendations regarding Phase II and Phase III clinical trials for drugs and biologics to treat or prevent COVID-19. The revised guidance was updated to include the new virus variants and authorized COVID-19 vaccines.

“The FDA is committed to identifying efficient ways to modify medical products that either are in the pipeline or have been authorized for emergency use to address emerging variants,” said Acting FDA Commissioner Janet Woodcock, MD, in a press release. “We know the country is eager to return to a new normal, and the emergence of the virus variants raises new concerns about the performance of these products. By issuing these guidances, we want the American public to know that we are using every tool in our toolbox to fight this pandemic, including pivoting as the virus adapts. We need to arm healthcare providers with the best available diagnostics, therapeutics, and vaccines to fight this virus. We remain committed to getting these life-saving products to the frontlines.”

The agency issued guidance for developers of vaccines, diagnostics, and therapeutics to address variants of the COVID-19 virus.

FDA Gives Guidance on COVID-19 Variants

Eli Lilly and Rigel Pharmaceuticals, a US-based biotechnology company, announced on Feb. 18, 2021 that they have entered into a license agreement and strategic collaboration to co-develop and commercialize Rigel's R552, a receptor-interacting serine/threonine-protein kinase 1 (RIPK1) inhibitor, for all indications, for $960 million.

Under the terms of the agreement, Eli Lilly will provide Rigel with an upfront payment of $125 million and an additional $835 million in potential development, regulatory, and commercial milestone payments, Eli Lilly said in a company press release. Eli Lilly will handle the costs of the global commercialization of R552, while Rigel will maintain the right to co-commercialize R552 in the United States.

R552 has completed Phase I clinical trials and will begin Phase II clinical trials in 2021, according to the company press release. Additionally, Rigel has ongoing pre-clinical activities with its lead central nervous system (CNS) penetrant RIPK1 inhibitor candidates, for which Eli Lilly will handle all clinical development and commercialization.

"At Lilly, our immunology strategy is focused on the pursuit of novel targets that have the potential to develop into best-in-class medicines for patients with autoimmune conditions," said Ajay Nirula, MD, PhD, vice-president of immunology at Eli Lilly, in the press release. "RIPK1 inhibitors are a promising approach, and R552 is an exciting addition to our immunology pipeline. We look forward to working with Rigel to advance its clinical development."

"We are very excited to form this strategic partnership with Lilly. This collaboration will provide significant resources and expertise to support a broad investigation in multiple disease indications with our RIPK1 inhibitors," added Raul Rodriguez, Rigel's president and CEO, in the press release. "With Lilly's extensive knowledge in immune and CNS diseases, they are our ideal partner to ensure the clinical and commercial success of our RIPK1 inhibitor program."

The companies will co-develop and commercialize Rigel's R552, a receptor-interacting serine/threonine-protein kinase 1 (RIPK1) inhibitor, for all indications.