Pharmaceutical Technology Editors

BioVaxys Technology, a Canadian clinical-stage biopharmaceutical company, announced on March 15, 2021 that it has entered into an agreement with WuXi Biologics, the contract development and manufacturing organization business unit of Wuxi AppTec, to produce SARS-CoV-2 s-proteins for BioVaxys’ COVID-19 vaccine candidate, BVX-0320, and for its Covid-T immunodiagnostic program.

Under the terms of the agreement, WuXi will produce high yields of fully characterized SARS-CoV-2 s-protein for BioVaxys’ preclinical safety study of its Covid-T diagnostic, BioVaxys said in a company press release. The recombinant s-protein will be created and expressed using WuXi Biologics’ proprietary vector, allowing BioVaxys to secure the level of purity, consistency, and protein characterization expected by FDA.

The s-protein will also be used in BVX-0320, which is being prepared for a clinical study this year.

“Establishing a bioproduction method for a steady supply of purified and fully characterized s-protein from a validated process will enable us to quickly transition from having the GLP material for the upcoming Covid-T animal toxicity study to having a steady source [of] the GMP-grade s-protein for clinical trials later this year,” said Ken Kovan, BioVaxys president and chief operating officer, in the press release. “Now that we know the gene sequences, a further major benefit of our relationship with WuXi will be our ability to quickly source the s-protein of newly emerging SARS-CoV-2 variants for use in a planned multi-valent version of BVX-0320 and line extensions of Covid-T.”

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WuXi will produce SARS-CoV-2 s-proteins for BioVaxys’ COVID-19 vaccine candidate, BVX-0320, and for its Covid-T immunodiagnostic program.

BioVaxys and WuXi to Collaborate on SARS-CoV-2 S-Protein Production

Sagent Pharmaceuticals announced on March 11, 2021 that it is voluntarily recalling three lots of Phenylephrine Hydrochloride Injection, USP (10 mg/mL), an alpha-1 adrenergic receptor agonist for the treatment of low blood pressure resulting from the dilation of blood vessels, to the user level because of a customer complaint regarding potentially loose crimped vial overseals, which can result in a non-sterile product.

Administering a product intended to be sterile but that is not sterile could result in systemic infections which may be life-threatening, FDA said in a press release. Sagent is recalling lot numbers PHT8IB2, PHT9IB2, and PHT1JB2 distributed nationwide in the US from Nov. 17, 2020 to March 8, 2021. Currently, the company has not received any reports of adverse events associated with the product.

Sagent Pharmaceuticals is voluntarily recalling three lots of Phenylephrine Hydrochloride Injection, USP (10 mg/mL) to the user level because of a customer complaint regarding potentially loose crimped vial overseals, which can result in a non-sterile product. 

Sagent Pharmaceuticals Issues Voluntary Nationwide Recall for its Low Blood Pressure Treatment

The Coalition for Epidemic Preparedness Innovations (CEPI) announced on March 10, 2021 that governments and global health organizations have shown their support for CEPI’s $3.5 billion plan to reduce or eliminate the future risk of pandemics and epidemics.

According to a company press release, CEPI plans to dedicate $1 billion of the $3.5 billion toward the research and development of new vaccines aimed at variants of concern. The company also plans to launch a call for proposals at the end of March 2021 that will provide $200 million in funding for an “all-in-one” vaccine that could protect against several strains of coronaviruses, including SARS, MERS-CoV, and SARS-CoV-2.

Additionally, CEPI released a six-point strategy to prepare for the next possible outbreak. Its strategies include:

Reducing the risk of a future coronavirus pandemic by improving current vaccines, targeting variants of concern, developing new vaccines, and developing universal vaccines.

Developing and completing vaccines for additional known threats, including chikungunya, Lassa fever, Nipah, MERS, Rift Valley fever, and Ebola.

Limiting vaccine development timelines to 100 days.

Organizing a library of protype vaccines.

Creating global networks for lab capacity, assays, and preclinical models for rapid vaccine development.

Taking full ownership of low- and middle-income countries’ national health security by conducting epidemiological and clinical studies, supporting technology transfer, and establishing national and regional vaccine manufacturing.

Currently, supporters of the plan include the governments of Germany, Norway, and Ethiopia; Wellcome and the Bill and Melinda Gates Foundation; the World Economic Forum; and the World Health Organization, Gavi, and UNICEF, according to the press release.

“Reducing the risk of future pandemics and epidemics is a critical global issue that will benefit every single human on earth,” said Richard Hatchett, CEO, CEPI, in the press release. “The backing from governments and global health bodies for CEPI’s plan is testament to the importance of this issue, and the unique role that CEPI plays in this global effort. Our five-year plan is ambitious, yet achievable, and we look forward to working with everyone who has backed us so far to protect the world from the devastating impacts of pandemics and epidemics.”

Currently, supporters of the plan include the governments of Germany, Norway, and Ethiopia; Wellcome and the Bill and Melinda Gates Foundation; the World Economic Forum; and WHO, Gavi, and UNICEF.

CEPI Plans to Reduce Risk of Future Pandemics and Epidemics with Global Leaders’ Support and a $3.5 Billion Plan

Sotera Health, a US-based provider of sterilization, lab-testing, and advisory services, announced on March 10, 2021 that it has acquired BioScience Laboratories, a topical antimicrobial product testing company located in the US.

The acquisition will expand the antimicrobial and antiviral testing capabilities of Sotera’s Nelson Labs business in the US, Sotera said in a company press release. Financial details of the acquisition were not disclosed.

“BioScience Laboratories is premier provider of antimicrobial testing services; known for its testing of consumer hand sanitizers, pre-operating hand-wash, and hard surface disinfectants. It is also recognized for its strong relationships with its customers and regulators,” said Michael B. Petras Jr., chairman and CEO of Sotera Health, in the press release. “This acquisition will expand and further strengthen our antimicrobial and virology lab testing capabilities. We welcome BioScience Laboratories’ strong management and expert staff as they join us in our mission, safeguarding global health.”

The acquisition will expand the antimicrobial and antiviral testing capabilities of Sotera’s Nelson Labs business in the US.

Sotera Health Acquires BioScience Laboratories to Expand its Antimicrobial and Antiviral Testing Capabilities

I Holland, manufacturer of tablet tooling for the pharmaceutical and nutraceutical markets, has announced a number of appointments to form a new leadership team in a March 2, 2021 press release.

Six team members, many of which were on the previous management team, comprise the new board of directors, with David Hinds passing the managing director role to Javier Raposo—who has been the I Holland sales and marketing director for the last five years. Hinds will continue to serve on the board as non-executive director.

“It’s a huge honor to have been appointed managing director at I Holland,” Raposo said in the press release. “I look forward to working alongside my fellow board members and company management to turn a new chapter of growth and drive forward the fundamental principles that make the brand so unique.”

Other changes include, Steve Deakin, customer service director, who will be a non-executive chairman on the board, and Matt Pullen, who will take on the role of operations director after his time spent as director of manufacturing. Rob Chatwin will continue his role as finance and IT director, and Dan Fitzsimmons will continue to serve as the regional managing director of Asia Pacific.

I Holland, manufacturer of tablet tooling for the pharmaceutical and nutraceutical markets, has announced a number of appointments to form a new leadership team

I Holland Forms New Senior Management Team

On March 11, 2021, Cell and Gene Therapy Catapult (CGT Catapult) announced that GlaxoSmithKline (GSK) will expand its clinical trial manufacturing capacity for cell and gene therapies at CGT Catapult’s facility in Stevenage, UK. GSK will perform good manufacturing practice (GMP) cell processing at the facility to accelerate its cell and gene therapy pipeline for clinical trials.

Through the agreement, GSK will improve its GMP cell processing network to advance its early stage pipeline and streamline technical transfer, marking another significant step in the growth of cell and gene therapy activities in Stevenage and the UK as a whole. The added experience of GSK builds on expertise already in place with current CGT Catapult collaborators and will allow for the development of new capabilities to benefit future and current collaborators, already present and progressing their manufacturing onsite, CGT Catapult said in a company press release.

The UK currently has more than 90 advanced therapy medicinal products (ATMP) therapy developers, and in 2020 has seen an increase of 48% in the UK GMP manufacturing space for cell and gene therapies. This increase also reflects the expansion of the CGT Catapult Stevenage facility, which included six additional cleanrooms.

“The UK already has significant capabilities in cell and gene therapy, and this agreement illustrates how strategic investments by GSK can make them even stronger. Working more closely with CGT Catapult will help us advance our promising cell and gene therapy programs and bring these transformative medicines more quickly to the patients who desperately need them,” said Tony Wood, senior vice-president, Medicinal Science and Technology, GSK in the press release.

“The move by a leading pharmaceutical company like GSK to establish ATMP manufacturing capabilities at the CGT Catapult facility in Stevenage highlights the UK’s globally leading position for large and smaller organizations alike to develop, manufacture, and deliver cell and gene therapies. With a range of collaborators already based in the facility, we look forward to participating in the collective innovation onsite to pioneer the growth in scale of advanced therapy manufacturing,” added Matthew Durdy, CEO of Cell and Gene Therapy Catapult, in the press release.

This agreement enhances GSK’s investment in cell and gene therapy manufacturing in the UK for clinical trials.