Pharmaceutical Technology Editors

The European Medicines Agency (EMA) has requested that developers determine if their COVID-19 vaccines protect against new virus mutations that have been identified in the United Kingdom, South Africa, and Brazil. On Feb. 10, 2021, the agency 

 that it is developing guidance to assist manufacturers in making changes to existing COVID-19 vaccines in order to treat these variants in the coronavirus.

A reflection paper will describe the data and studies needed to support changes to existing vaccines to treat mutations to SARS-CoV-2 in the European Union. The paper will address options for introducing a new strain into an existing approved vaccine; the minimal regulatory requirements for quality, safety, and efficacy; and bridging studies required to provide reassurance of a vaccine’s efficacy against a new strain.

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The agency is developing guidance to help manufacturers make changes to existing COVID-19 vaccines to treat new variants in the coronavirus.

EMA Guidance on Changes to COVID-19 Vaccines to Fight Variants

New technologies, such as artificial intelligence and machine learning, are being employed by bio/pharma manufacturers to collect and analyze large amounts of process data in real-time. Hear an expert panel will discuss how this technology can be employed to optimize bio/pharma manufacturing and predictive maintenance.

This Editors’ Series panel discussion, moderated by the editors of 

 features Bikash Chatterjee, CEO, Pharmatech Associates; Pamela Docherty, life sciences industry manager, Siemens; Amos Dor, general manager of the Pharma team, automation products group, Applied Materials; and Bob Lenich, global life sciences director, Emerson.

The panel discussion—Technology Advances in Process Operations: Using Real-time Montioring and Artificial Intelligence to Optimize Manufacturing Operations was recorded during the 2020 Bio/Pharma Virtual Congress on Nov. 11, 2020.

Videos

How can artificial intelligence and machine learning be used to gather and process real-time manufacturing data? 

Employing AI and Machine Learning to Advance Process Operations

AbbVie and Caribou Biosciences, a US-based clinical-stage clustered regularly interspaced short palindromic repeats (CRISPR) genome editing biotechnology company, announced on Feb. 10, 2021 that they are entering into a collaboration and license agreement for the research and development of chimeric antigen receptor (CAR)-T cell therapeutics.

Under the terms of the agreement, Caribou will receive an upfront cash payment of $40 million and $300 million in future development, regulatory, and launch milestones, Caribou said in a company press release. AbbVie will also obtain access to Caribou’s next-generation Cas12a CRISPR hybrid RNA–DNA genome editing and cell therapy technologies to develop two new CAR-T cell therapies. AbbVie will handle the clinical development, commercialization, and manufacturing of the cell therapies, while Caribou will conduct pre-clinical research, development, and manufacturing of the therapeutics.

“We are excited to partner with AbbVie on the development of new CAR-T cell therapies. This collaboration validates Caribou’s differentiated next-generation CRISPR genome editing technologies that provide best-in-class efficiency and specificity,” said Rachel Haurwitz, PhD, president and CEO of Caribou, in the press release. “We believe AbbVie is an ideal partner for Caribou as we expand upon the number of targets and diseases addressable by our technologies. Genome-edited CAR-T cell therapies hold tremendous potential for patients, and this partnership accelerates our ability to address significant unmet medical need.”

“CAR-T therapies have shown to be a promising breakthrough in cancer treatment,” added Steve Davidsen, PhD, vice-president, Oncology Discovery, AbbVie, in the press release. “Collaborating with Caribou and their cutting-edge CRISPR platform will help AbbVie advance our efforts to deliver new hope for patients.”

Through the agreement, AbbVie will use Caribou’s next-generation Cas12a CRISPR hybrid RNA–DNA genome editing and cell therapy technologies to develop two new CAR-T cell therapies.

AbbVie to Collaborate with Caribou Biosciences on CAR-T Cell Therapeutics

Lonza announced on Feb. 8, 2021 that it has divested its specialty ingredients business and operations to Bain Capital and Cinven, two private equity firms, for $4.2 billion. 

The transaction is set to close in the second quarter of 2021, Lonza said in a company press release. Lonza’s specialty ingredients business works across 17 manufacturing sites globally and employs 2800 permanent employees.

“Today’s announcement is the result of a comprehensive and robust selection process,” said Albert M. Baehny, chairman, Lonza, in the press release. “Bain Capital and Cinven have shown they understand the value of the experience and expertise of our Specialty Ingredients employees. They presented the most compelling industrial strategy and vision for the business, they are also keen to prioritize R&D and innovation, as well as to invest in existing facilities to unlock the potential of the business.”

“The sale of the specialty ingredients business will allow Lonza to focus on its position as a leading partner to the healthcare industry, and the free cash flows resulting from the sale will allow us to accelerate our strategic priorities,” Baehny added in the press release. “We look forward to continuing to collaborate with Bain Capital and Cinven to ensure a seamless transition for customers and employees.”

The company has divested its specialty ingredients business and operations to Bain Capital and Cinven, two private equity firms.

Lonza to Divest its Specialty Ingredients Business and Operations for $4.2 Billion

FDA has outlined action plans to address the potential impact emerging SARS-CoV-2 coronavirus variants may have on the effectiveness of vaccines and therapies in development or approved under Emergency Use Authorization. The agency promised transparency and an all-hands-on-deck effort to address multiple public health needs in a Feb. 4, 2021 statement.

The statement from Acting Commissioner Janet Woodcock noted the agency’s “need to adapt and pivot to support modification or development of these lifesaving tools as new variants of coronavirus are identified.”

The statement also noted that FDA has been assessing the impact of new strains on medical products and diagnostic tools and is working with sponsors and international partners to assess the implications. In addition, FDA is developing guidance documents for diagnostic, therapeutic, and vaccine developers to help guide ongoing medical product development.

The agency will turn to its experience and regulatory processes employed with evolving infectious diseases, citing the modifications to influenza vaccines and diagnostics, which often change annually to address the predicted predominant strains, Woodcock noted in the statement.

“We will utilize our experience with influenza to help inform a path forward if SARS-CoV-2 variants emerge against which currently authorized vaccines are not sufficiently effective,” the statement noted. “Similarly, the FDA also has vast experience with HIV developing resistance to antiviral drugs and will follow regulatory pathways to quickly enable new antiviral drug development for resistant virus.”

Recognizing that some of the authorized neutralizing monoclonal antibody therapies are less effective against the new virus strains, FDA is considering “appropriate regulatory flexibilities” to help expedite drug development, including approaches to the generation and evaluation of preclinical, clinical, and chemistry, manufacturing and controls data.

For authorized vaccines, FDA teams are discussing what data are needed to support changes in the composition of the vaccine, including ways sponsors could demonstrate immune response to new variants through streamlined clinical programs.

“To be clear, while we continue to develop an understanding of and address any impact of variants on FDA-regulated products, at this time, available information suggests that the authorized vaccines remain effective in protecting the American public against currently circulating strains of COVID-19,” the statement clarified.

The agency also is conducting scenario planning to anticipate impacts to products and supply chains as quickly as possible and will share this information with the public when it is available.

“We are committed to identifying efficient processes for authorized products that may need to be modified, based on information on emerging variants. We do not believe there will be the need to start at square one with any of these products—we recognize we are in a pandemic and we need to arm health care providers with the most appropriate tools to fight this pandemic on the frontlines,” the statement noted. “We do not want to create obstacles to getting these tools to the frontlines.”

FDA considers regulatory flexibility to allow the agency and sponsors to adapt and pivot to changes in coronavirus. 

FDA Outlines Strategy to Address Virus Variants

Catalent announced on Feb. 8, 2021 that it has entered into an agreement with Trizell, a German biotech company, to manufacture Trizell’s Phase I cell therapy for the treatment of micro- and macroangiopathies.

Under the terms of the agreement, development of the cell therapy will take place at the University Medical Center Schleswig Holstein, Department of Anesthesiology and Intensive Care Medicine, the Clinic for Applied Cellular Medicine, and the Department of Cardiovascular Surgery, while the manufacturing will take place at Catalent’s facility in Gosselies, Belgium, Catalent said in a company press release.

“This is an important milestone for Trizell and the therapy for the treatment of macro- and microangiopathies,” said Sibille Engels, PhD, CEO, Trizell, in the press release. “I am delighted to enter into this collaboration with Catalent and to benefit from its outstanding expertise in cell and gene therapy manufacturing.”

“Our relationship with Trizell will build on Catalent’s deep knowledge in immunotherapies, from the diagnosis and de-risk stage all the way through to commercial-ready processes,” added Manja Boerman, PhD, president, Catalent Cell & Gene Therapy, in the press release. “Extending into areas such as macrophages, allows us to stay on the forefront of emerging indications and cell types. The process development, manufacturing expertise, and the experienced production teams we have at Gosselies will enable a faster transition from development to manufacturing.”

Through the agreement, Catalent will manufacture Trizell’s Phase I cell therapy for the treatment of micro- and macroangiopathies at its Belgium facility. 