Pharmaceutical Technology Editors

In a March 18, 2021 press release, the BioIndustry Association (BIA) has released comments urging the UK government to take a science-based approach to the regulatory framework for gene editing and genetically modified organisms (GMOs).

The BIA’s comments have been submitted to the Department for Environment, Food and Rural Affairs (Defra), which is undergoing consultation on the regulation of genetic technologies. A judgement by the Court of Justice of the European Union (CJEU) on regulating gene edited products as GMOs has been a key focus for the consultation, from which BIA has advised the government to diverge.

Additionally, BIA has also requested that the government put in place an exemption scheme for medicines containing or consisting of GMOs that are undergoing clinical trials. By approaching the regulation of gene editing and GMOs in a more innovation-friendly way, BIA reports that the United Kingdom would remain a globally competitive location for clinical development and patients would gain rapid access to potentially curative medicines.

“Gene editing and GMOs have enormous potential to help us tackle health and environmental problems. Defra’s consultation on the regulation of genetic technologies is a clear opportunity to ensure the UK is at the forefront of these technologies and upholds its position as an attractive destination for foreign investment and top global talent to conduct their research,” said Steve Bates OBE, CEO of BIA, in the press release. “Given the CJEU’s judgment to regulate gene edited products as GMOs, it should be noted that the wider GMO regulations on the UK’s statute are burdensome and ineffective. Without addressing the underlying problems of these regulations, the UK will not be able to reap the benefits of gene editing and GMOs, whether in healthcare or tackling climate change. By adopting a science-based regulatory system which regulates the product instead of the process and has the confidence of the public, the UK would enable more start-ups to be created from our excellent science base, attract global investment, help deliver on the government’s levelling up agenda and ambition to make the UK a global life sciences cluster.”

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BIA has released comments urging the UK government to take a science-based approach to the regulatory framework for gene editing and GMOs.

BIA Urges Adoption of Science-Based Approach to Gene Editing and GMO Regulations

Alcami announced on March 18, 2021 that its board of directors has named Patrick D. Walsh as its new chairman and CEO. Walsh will take over the role from Walter J. Kaczmarek III, who is stepping down as CEO.

Before joining Alcami, Walsh served as CEO of AAIPharma Services, a predecessor company to Alcami, from 2010 to 2014; CEO of Avista Pharma from 2015 to 2019; and most recently served as co-founder and CEO of TriPharm Services, a parenteral manufacturing business, according to an Alcami press release. Along with his duties at Alcami, Walsh currently serves as chairman of ANI Pharmaceuticals, a director at Landec Corporation, and a director at Industria Chemica Emiliano.

"Patrick's impressive track record of driving growth and achieving high client satisfaction at leading pharmaceutical businesses makes him the ideal executive to lead Alcami forward,” said Jason Shideler, a managing director on Madison Dearborn Partners’ Health Care team and lead director at Alcami, in the press release. “He brings a depth of industry knowledge and leadership experience that will support Alcami’s strategic efforts to continue to add scale in attractive growth markets and deliver high-quality services to the pharmaceutical industry.”

"I have long-admired Alcami for its excellent regulatory track record and ability to solve complex product development and manufacturing challenges,” Walsh added in the press release. “I look forward to working with the talented team at Alcami as we continue to expand its footprint and build upon its services offerings."

Patrick D. Walsh will take over the role from Walter J. Kaczmarek III, who is stepping down as CEO.

Alcami Appoints New Chairman and CEO

Aceto, a virtual manufacturer of specialty materials for life sciences and advanced technology end markets, announced on March 15, 2021 that it has introduced an expanded portfolio for biopharmaceutical and cell culture reagent manufacturers.

Using the capabilities of Pharma Waldhof, one of Aceto’s facilities in Düsseldorf, Germany, the company plans to provide customers with access to raw materials including nucleotides, nucleosides, and bio-buffers, along with tested products for pharmaceutical cell culture applications, such as ingredients for hybridoma and Chinese hamster ovary cell culture media used in biopharmaceutical and vaccine manufacturing, Aceto said in a company press release. The expansion will also supply customers with cell culture media ingredients such as amino acids and vitamins.

“Aceto is active in new product development and advanced manufacturing techniques to position the company as a preferred supplier to the highly regulated biopharma and cell culture industries” said Gilles Cottier, CEO, Aceto, in the press release. “Using the extensive Aceto network worldwide makes it easier for customers to access their robust portfolio of products, while working with a company that is vested in its customers’ success.”

Using the capabilities of Pharma Waldhof, one of Aceto’s facilities in Düsseldorf, Germany, the company plans to provide customers with access to raw materials, tested products for pharmaceutical cell culture applications, and cell culture media ingredients. 

Aceto Expands Biopharmaceutical and Cell Culture Reagent Portfolio to Meet Customer Demand

Catalent announced on March 17, 2021 that it has expanded its partnership with Janssen Pharmaceutica NV and Janssen Pharmaceuticals, two of the Janssen Pharmaceutical Companies of Johnson & Johnson, under which Catalent Biologics will increase manufacturing capacity at its Anagni, Italy, site to accommodate the large-scale commercial supply of Janssen’s COVID-19 vaccine.

Under the terms of the expanded agreement, which also includes vial-filling, inspection, labeling, and packaging services, Catalent will fast-track the qualification and scale-up of an additional high-speed vial-filling line that is set to be operational in the fourth quarter of 2021 to support vaccine production through late 2022, Catalent said in a company press release.

“We are pleased to expand our partnership with Janssen to support demand of its COVID-19 vaccine in Europe,” said Mario Gargiulo, president, Catalent Biologics, Europe, in the press release. “Our global network of state-of-the-art biologics facilities, combined with our deep expertise in manufacturing scale-up and commercial launch, is well-suited to help provide a solution to this public health crisis.”

Under an expanded agreement with J&J, Catalent Biologics will increase manufacturing capacity at its Anagni, Italy, site to accommodate the large-scale commercial supply of Janssen’s COVID-19 vaccine. 

Catalent to Increase Manufacturing Capacity at Italian Facility for J&J COVID-19 Vaccine 

Provider of induced pluripotent stem cell (iPSC)-derived cells, media, and characterization services, Axol Bioscience, has signed a merger agreement with Censo Biotechnologies, a cell biology contract research organization.

According to a March 17, 2021 press release, the newly merged entity will provide product and service solutions in the iPSC-based neurosciences, immune cell, and cardiac modeling for drug discovery and screening markets. Additionally, the merged company will offer customers validated ready-to-use cell lines and a suite of services incorporating expertise, functional data, and customization capabilities.

As per the terms of the merger agreement, the CEO of Axol Bioscience, Liam Taylor, and the senior leadership team of Axol will take over the management of the combined company. The intention will be for Censo Biotechnologies to be migrated into the Axol Bioscience brand. Tom Stratfor, Censo’s interim CEO, is being appointed as non-executive director of the combined board, on behalf of Par Equity.

“Axol has experienced a rapid increase in demand for their iPSC-based products and services over the last three years. Merging with Censo immediately and significantly grows our scientific team and breadth of expertise,” said Taylor in the press release. “That [growth], and the addition of two sites for iPSC-derived cell line manufacturing and custom service work, will increase our production capacity and future-proof our organization to ensure demand can continue to be met with the short lead times and quality that our customers depend on.”

“Censo’s strength is our scientific team, as trusted partners in designing, executing, and managing custom project work. The combined entity will now be able to leverage Axol’s strength in iPSC-derived cells as well as complementary services such as electrophysiology to further our ability and efficiency to serve customers,” Stratford added in the press release. “We bring to bear capabilities, bandwidth, and expertise to scale the manufacturing of those tools in a way that benefits both customer bases and the wider market.”

Provider of iPSC-derived cells, media, and characterization services, Axol Bioscience, has signed a merger agreement with Censo Biotechnologies, a cell biology CRO.

Axol Bioscience, Censo Biotechnologies Sign Merger Agreement

Tevogen Bio, a clinical stage biotechnology company, announced on March 15, 2021 that it has entered into a partnership with BioCentriq, a cell and gene therapy development and manufacturing center, to support clinical manufacturing of Tevogen’s investigational T-cell therapy COVID-19 treatment.

Under the terms of the agreement, the companies will collaborate at BioCentriq’s GMP facilities to produce Tevogen’s proprietary COVID-19 targeted T cells, Tevogen said in a company press release. Currently, an Investigational New Drug application for the T-cell therapy is being reviewed by FDA.

“T-cell therapies are the next frontier of medicine, and we are thrilled to partner with such a prestigious research institute at the forefront of cell and gene therapy to support our mission to create affordable and scalable curative therapies,” said Ryan Saadi, MD, chairman and CEO of Tevogen, in the press release.

The companies will collaborate at BioCentriq’s GMP facilities to produce Tevogen’s proprietary COVID-19 targeted T cells.