Pharmaceutical Technology Editors

Zydus Pharmaceuticals (USA) Inc. (Pennington, NJ) 

 on March 24, 2021 that it was voluntarily recalling four lots of Acyclovir Sodium Injection, 50 mg/mL, in 10 mL and 20 mL vials. The recall is a result of complaints of crystallization in vials. According to the company, administration of crystallized product could result in life-threatening adverse reactions, such as obstruction of blood vessels and blood clots.

The recalled product is packaged in single-dose glass vials. Specific information on the recalled lots can be found on FDA’s website. It was distributed nationwide in the United States to Cardinal Health, AmerisourceBergen Drug Corporation, and Morris & Dickson Company LLC. As of the date of the company announcement, the company has not received any reports of adverse events. Adverse events may be reported to FDA via the agency’s MedWatch program.

Acyclovir Sodium Injection, 50 mg/mL is used to treat herpes simplex infections in immunocompromised patients, severe initial clinical episodes of herpes genitalis in immuno-competent patients, herpes simplex encephalitis, neonatal herpes simplex virus infection, and varicella-zoster (shingles) infections in immunocompromised patients, according to the company.

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The company is recalling the product because of crystallization in vials.

Zydus Pharmaceuticals (USA) Inc. Recalls Acyclovir Sodium Injection, 50 mg/mL 

on March 26, 2021 that its human medicines committee (CHMP) has approved a new manufacturing site in Leiden, the Netherlands for AstraZeneca’s COVID-19 vaccine active substance, bringing the total number of licensed manufacturing facilities available to four.

CHMP also approved a new facility in Marburg, Germany for the production of the Pfizer-BioNTech COVID-19 vaccine. The facility will manufacture the active substance and the finished product. CHMP also gave a positive opinion to allow transportation and storage of the vaccine between -25 to -15˚C for a one-off period of two weeks, an alternative to long-term storage of the vials at a temperature between -90 to -60˚C in special freezers. EMA stated in a press release that this new transportation and storage option will reduce the need for ultra-low temperature conditions throughout the supply chain and increase distribution of the vaccine in the European Union.

Moderna’s COVID-19 vaccine also got an additional manufacturing site approved by CHMP in March for the production of active substance and finished product intermediates. “The addition of the new manufacturing lines at the Lonza facility, located in Visp, Switzerland, together with other changes to the manufacturing processes that were greenlighted by the Committee are intended to scale-up production capacity and increase supply of the vaccine for the EU market,” EMA stated in the release.

The agency’s human medicines committee has approved new manufacturing sites for COVID-19 vaccines.





EMA Adopts Recommendations to Increase COVID-19 Vaccine Capacity

Bristol Myers Squibb and bluebird bio announced on March 26, 2021 that FDA has approved Abecma, the first B-cell maturation antigen-directed chimeric antigen receptor (CAR) T cell immunotherapy for the treatment of adult patients with relapsed or refractory multiple myeloma after four or more prior lines of therapy.

The CAR T cell therapy, which is being jointly developed and commercialized by the companies, was approved after positive data from a Phase II trial showed ide-celelicited rapid responses in the majority of the 127 patients participating in the study, Bristol Myers Squibb said in a company press release.

“Transformational potential for the treatment of hematologic malignancies, and we, with our partners at bluebird bio, are proud to bring the first CAR T cell therapy to appropriate triple-class exposed patients with relapsed or refractory multiple myeloma, offering the chance for durable response,” said Samit Hirawat, MD, chief medical officer, Bristol Myers Squibb, in the press release. “As our second FDA-approved CAR T cell therapy, Abecma underscores our commitment to deliver on the promise of cell therapies for patients who are battling aggressive and advanced blood cancers with limited effective treatment options.”

“Our journey to today’s approval of Abecma started nearly a decade ago with pioneering research at bluebird bio and has been driven ever since by our mission to provide patients with multiple myeloma a new approach to fight this relentless disease. This achievement would not have been possible without all of the patients, caregivers, investigators, and healthcare staff who participated in our clinical studies, as well as the tremendous collaboration with the FDA,” said Nick Leschly, chief bluebird, bluebird bio, in the press release. “Today’s announcement represents an important milestone for bluebird bio, marking both our first approved treatment in oncology, and our first approved treatment in the United States.”

Abecma is the first B-cell maturation antigen-directed chimeric antigen receptor T cell immunotherapy for the treatment of adult patients with relapsed or refractory multiple myeloma after four or more prior lines of therapy.

FDA Approves Bristol Myers Squibb and bluebird bio’s CAR T Cell Therapy for Refractory Multiple Myeloma

BioCentriq, a US-based gene therapy development and manufacturing center, announced on March 23, 2021 that it has entered into a partnership with Kytopen, a startup spun out of the Massachusetts Institute of Technology.

Under the terms of the agreement, the companies will work together to determine the impact on autologous and allogeneic cell therapies by combining Kytopen’s proprietary Flowfect technology for non-viral cell engineering with other steps in the manufacturing process, BioCentriq said in a company press release.

“The Flowfect platform is a transformative solution that eliminates the complexity of gene delivery for cell engineering and links discovery, development and manufacturing in one flexible scalable solution,” said Paulo A. Garcia, PhD, CEO and co-founder of Kytopen, in the press release. “Our goal is to enable simple and efficient non-viral manufacturing of cell therapies in days versus weeks to help patients; our partnership with BioCentriq accelerates that goal.”

“Our mission at BioCentriq is to work with innovative industry partners like Kytopen to advance the production and manufacturing of cell and gene therapies, making them accessible and affordable for the patients who so desperately need them” added Haro Hartounian, PhD, senior vice-president, general manager, BioCentriq, in the press release. “This partnership aligns perfectly with that mission.”

The companies will work together to determine the impact on autologous and allogeneic cell therapies by combining Kytopen’s proprietary Flowfect technology for non-viral cell engineering with other steps in the manufacturing process.

BioCentriq to Partner with Kytopen for Cell Therapy Manufacturing 

Piramal Pharma Solutions (PPS), Piramal Pharma Limited’s contract development and manufacturing organization, announced on March 23, 2021 that it has entered into a master services agreement with Plus Therapeutics, a US-based clinical-stage pharmaceutical company, under which Piramal will offer development, manufacture, and supply services for Plus Therapeutics’ rhenium nanoliposome (RNL)-liposome intermediate drug product.

Under the terms of the agreement, transfer of analytical methods, development of microbiological methods, process transfer and optimization, intermediate drug product manufacturing, and stability studies will be performed at PPS’ drug product facility in Lexington, KY, PPS said in a company press release. The companies will aim to establish clinical and commercial supply agreements for the drug product at the appropriate stage of development through the agreement.

“We are excited to partner with Plus Therapeutics. We believe that this represents the start of a long, collaborative, and mutually beneficial relationship that will address our ultimate objective of reducing the burden of disease on patients,” said Peter DeYoung, CEO, Pharma Solutions, Piramal Pharma Limited, in the press release.

“This agreement represents another significant milestone for Plus, as we work to advance development of RNL as a novel treatment option for patients diagnosed with glioblastoma,” said Marc Hedrick MD, president and CEO of Plus Therapeutics, in the press release. “The team at PPS has the knowledge, experience, and expertise to support our needs, both now and in the future as we advance RNL towards regulatory approval.”

The companies will aim to establish clinical and commercial supply agreements for Plus Therapeutics’ RNL-liposome drug product at the appropriate stage of development. 

Piramal Pharma Solutions to Provide Intermediate Drug Product Services to Plus Therapeutics 

LabVantage Solutions, a laboratory informatics solutions and services provider, announced on March 25, 2021 that it has named Mikael Hagstroem as its new CEO.

Before taking on his new role, Hagstroem served as CEO and president at MetricStream, an independent provider of governance, risk, and compliance products and solutions; partner at McKinsey & Company and chief operating officer of McKinsey Analytics; and executive vice-president of the SAS Institute and president of SAS International, LabVantage said in a company press release. Additionally, Hagstroem is currently on the board of advisors of the Artificial Intelligence (AI) Forum and has served as chair of the World Economic Forum’s Global Agenda Council on Data-Driven Development, as a member of the executive committee of the US Council for International Business, and as an executive board member of the Atlantic Council.

“[Hagstroem] embodies the sense of purpose and passion required to tackle big goals and the expertise to achieve them,” said Purnendu Chatterjee, chairman of LabVantage Solutions, in the press release. “He is an accomplished business leader who has built innovative data-based enterprises across a range of industries. He is a visionary strategist who understands the transformational potential of advanced technologies and translates them into actionable business initiatives. An inspired leader, [Hagstroem] is committed to accelerating the use of new tools such as analytics and AI to address urgent global problems. We are thrilled to welcome him to LabVantage and excited at the prospect of what we can accomplish together.”

“LabVantage brings the Fourth Industrial Revolution–characterized as a range of new technologies that are fusing the physical, digital, and biological worlds and impacting all disciplines, economies, and industries–to the lab, and I am honored to take the helm,” Hagstroem added in the press release.

Mikael Hagstroem has been named as the company’s new CEO. 