Pharmaceutical Technology Editors

Optima, a Germany-based special machine manufacturer, announced on June 10, 2021 that its Pharma Division has partnered with the Robert-Bosch-Krankenhaus (RBK), a charitable hospital in Stuttgart, Germany, and the Universitätsklinikum Heidelberg (UKHD) to develop a unit for decentralized, automated production of chimeric antigen receptor T cell (CAR-T) cell therapies under the ProCell for Patient project, a collaboration launched by the three organizations in late 2020.

The ProCell for Patient system prototype is scheduled to be installed at the RBK in the summer of 2022 and is expected to cut the amount of work needed to manufacture CAR-T cell therapies in half, Optima stated in a company press release. The manufacturing system should deliver benefits in terms of quality, cost, and time, according to Optima.

As part of a forerunner project with Charité Hospital in Berlin, Optima Pharma has already taken the first steps toward developing a suitable production unit. Roll-out to additional treatment centers and pharmaceutical contract developers and manufacturers is planned once testing and clinical trials have been completed. Clinics that are involved in decentralized manufacturing can also contribute in the future to optimizing and developing new cell therapies, the company said in its press release.

"The automation of CAR-T cell therapy production is long overdue. Not just for reasons of cost and quality. In the future, it will facilitate the innovation process," said Walter E. Aulitzky, chief physician of the Department of Oncology, Hematology, and Palliative Medicine at the RBK, in the press release.

"With the help of the ProCell for Patient system, it will probably be possible to reduce the amount of work, i.e., the number of hours that qualified staff today are spending on producing CAR-T cells, by at least 50 percent," said Andrea Traube, director, Market Development Pharma, Optima Pharma, in the press release.

The project is funded by the Ministry of Economic Affairs, Labour and Housing Baden-Württemberg as part of the "Forum Health Region Baden-Württemberg" initiative.

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Optima has teamed up with the Robert-Bosch-Krankenhaus and Heidelberg University to develop a unit for decentralized, automated production of CAR-T cell therapies.

Optima Teams Up with Clinics to Develop Production Unit for CAR-T Cell Therapies

, James Blackwell, president of The Windshire Group, LLC, explains key actions the biopharma can learn from its response to the COVID-19 pandemic that can be applied to improve process development for non-pandemic development programs.

What can the biopharma industry learn from its rapid response to the COVID-19 pandemic?

Process Development Improvements Post-Pandemic

Novavax announced on June 14, 2021, results from two studies of is recombinant nanoparticle protein-based COVID-19 vaccine; in a large study, the vaccine candidate demonstrated 90.4% efficacy overall and in a second small study, the efficacy showed only a modest decrease when co-administered with a seasonal influenza vaccine.

 enrolled nearly 30,000 participants in the United States and Mexico to evaluate efficacy, safety, and immunogenicity. The results showed an overall efficacy of 90.4%; 63 cases of COVID-19 were observed in the placebo group and 14 cases, defined as mild, occurred in the vaccine group. The company reported a vaccine efficacy of 100% against moderate or severe disease and success among high-risk populations.

Novavax also reported on June 14, 2021, data from 

a co-administration study of NVX-CoV2373 and an approved influenza vaccine

, which suggests simultaneous vaccination for COVID-19 and influenza may be a viable strategy.

As part of the company’s Phase III clinical trial of NVX-CoV2373 in the United Kingdom, approximately half the 431 participants who received the Seqirus influenza vaccine were also vaccinated with NVX-CoV2373; the rest received a placebo. The study showed that vaccine efficacy appeared to be preserved in those receiving both vaccines compared to those vaccinated with NVX-CoV2373 alone, the company reports. Few mild side effects such as pain at the injection site were reported.

Vaccine efficacy in the sub-study was 87.5% while efficacy in the main study was 89.8% against SARS-CoV-2. The company also reported that immunogenicity of the influenza vaccine was preserved with concomitant administration.

Novavax said that it intends to file for regulatory authorizations in the third quarter of 2021 and, if approved, is scheduled to manufacture 100 million doses per month by the end of the third quarter and 150 million doses per month by the end of the fourth quarter of 2021.

Novavax’s COVID-19 vaccine is 90.4% effective and maintains efficacy when administered with an influenza vaccine.

Novavax Reports on Two Vaccine Efficacy Studies

that it is authorizing two batches of vaccine drug substance manufactured at the Emergent BioSolutions Baltimore facility for the Janssen COVID-19 vaccine. FDA concluded the batches were suitable for use after a review of the facility records and results of quality testing. However, the agency did not include the Emergent plant as an authorized facility in Janssen’s Emergency Use Authorization.

“The FDA’s decision to include these two batches of vaccine drug substance in the EUA for the Janssen COVID-19 vaccine means that Janssen vaccine made with this drug substance can be used in the [United States] or exported to other countries. A condition on any export of these batches, or of vaccine manufactured from these batches, is that Janssen and Emergent agree that the FDA may share relevant information about the manufacture of the batches under an appropriate confidentiality agreement, with the regulatory authorities of the countries in which the vaccine may be used,” the agency stated in a press release.

FDA also extended the expiration date for the Janssen COVID-19 vaccine, extending the storage at 2–8 oC to 4.5 months from 3 months. The decision came after the agency reviewed information submitted from Janssen.

“These actions followed an extensive review of records, including the production history of the facility and the testing performed to evaluate the quality of the product. This review has been taking place while Emergent BioSolutions prepares to resume manufacturing operations with corrective actions to ensure compliance with the FDA’s current good manufacturing practice requirements,” said Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, in the press release. “Additionally, the action to extend the shelf life for the refrigerated Janssen vaccine means that jurisdictions that have doses on hand now have additional time to administer vaccine.”

The agency approved two batches of drug substance manufactured at the Emergent BioSolutions facility in Baltimore for use in the Janssen COVID-19 vaccine.

FDA Authorizes Use of Drug Substance for Janssen COVID-19 Vaccine

on June 11, 2021 that supervisory authorities in the European Union have recommended not releasing batches of Janssen’s COVID-19 that contain API manufactured at Emergent BioSolution’s Maryland facility around the same time as a known contaminated batch. According to EMA, batches of the vaccine that have been released in the EU are not contaminated, and the recommendation is a precaution to safeguard supplies.

Vaccine production was suspended at Emergent’s Bayview, Md. facility in April 2021 after a manufacturing error caused loss of product and an 

 found good manufacturing practice violations.

EMA stated in a press release that it is working with FDA and international partners to ensure the quality of COVID-19 vaccines.

As a safety measure, supervisory authorities in the European Union have recommended not releasing batches of Janssen’s COVID-19 vaccine with API manufactured at Emergent BioSolutions’ Maryland facility.

EU Regulators Recommend Not Releasing Batches of Janssen COVID-19 Vaccine

 on June 11, 2021 that its committee for human medicines (CHMP) has approved Recipharm’s Monts, France facility for the production of Moderna COVID-19 vaccine finished product. Several other sites were given a positive opinion by CHMP for batch control/testing.

The new site follows two other sites approved by CHMP in June for the manufacture of API and finished product intermediates in the United States. “Together, these changes are expected to allow the production of an additional one to two million vials of ready-to-use vaccine for the European Union market every month. This will increase the supply of the vaccine in the European Union,” the agency stated in a press release.

The new site in Monts, France, which is operated by Recipharm, will produce finished COVID-19 vaccine product.