Pharmaceutical Technology Editors

High Purity New England (HPNE), a supplier of single-use solutions for the biopharmaceutical industry, has launched its third new state-of-the-art facility. The facility is designed to accelerate HPNE’s ability to provide its customers with single-use assemblies and significantly increase the company’s manufacturing capacity.

The facility represents a $10 million investment, sized at approximately 80,000 square feet. It will serve as the company’s Specialty Manufacturing and Distribution Center. The facility features an extensive laboratory with four suites, an auditorium, a mock cleanroom for onboarding employees to practice gowning and S.O.P training, and two floors of warehouse space for materials and finished goods. It will also house additional office space and community space used for industry and local organizations, such as the Boys & Girls’ Club of RI and RI Bio.

HPNE supplies a range of products, including custom single-use assemblies, pumps, mixers, and other single-use solutions. The company’s total square footage is now greater than 130,000 square feet with the addition of the new facility, increasing their abilities to provide products to its customers.

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High Purity New England has launched its third facility, focused on single-use assemblies.

High Purity New England Launches Third Facility

GlaxoSmithKline (GSK) and Sierra Oncology, a late-stage biopharmaceutical company focused on treatments of rare forms of cancer, announced on April 13, 2022 that they have entered into an agreement under which GSK will acquire Sierra Oncology. The acquisition is valued at $1.9 billion at $55 per share of common stock in cash.

A main asset of Sierra Oncology is its treatment momelotinib, which has a differentiated mode of action with inhibitory activity along key signaling pathways. The treatment has the potential to address the critical unmet medical needs of myelofibrosis patients with anemia. GSK’s acquisition of the treatment will complement its existing expertise in hematology and support the development of a strong portfolio of new specialty medicines and vaccines.

Myelofibrosis is a fatal cancer of the bone marrow that impacts the normal production of blood cells. According to the press release, it is estimated that nearly all myelofibrosis patients will develop anemia, which limits existing treatment options, leading to poor prognosis and decreased overall survival.

“Sierra Oncology complements our commercial and medical expertise in hematology,” said Luke Miels, chief commercial officer of GSK. “Momelotinib offers a differentiated treatment option that could address the significant unmet medical needs of myelofibrosis patients with anemia, the major reason patients discontinue treatment. With this proposed acquisition, we have the opportunity to potentially bring meaningful new benefits to patients and further strengthen our portfolio of specialty medicines.”

GSK reaches agreement to acquire late-stage biopharmaceutical company Sierra Oncology for $1.9 billion.

GSK to Acquire Sierra Oncology for $1.9 Billion

Mylan Pharmaceuticals, a Viatris company, is voluntarily recalling one batch of its Insulin Glargine (Insulin glargine-yfgn) Injection, 100 units/mL (U-100), due to the potential for a missing label in the batch. The product is packaged in a 10 mL vial that is inside a carton. The label may be missing on some vials, and the product information, batch number and expiry date information are present on the carton. The product is meant as a treatment for adults and pediatric patients with type 1 diabetes mellitus and for adults with type 2 diabetes mellitus.

The recall does not pertain to the branded interchangeable biosimilar, Semglee injection, but the unbranded Insulin Glargine-yfgn vial. The impacted batch was manufactured by Biocon Sdn. Bhd and was distributed by Mylan Specialty L.P. in the United States between Dec. 9, 2021 and March 4, 2022.

A missing label on Insulin Glargine vials has the potential to lead to a mix-up of products/strengths, which may result serious complications due to less optimal glycemic control (either high or low blood sugar), especially in patients receiving treatment with more than one type of insulin, according to the company. No adverse events related to the recall have been received by the company to date.

The company has initiated the recall of the batch, batch BF21002800, and notified its distributers and retailers by letter requesting for the return of all recalled products.

Mylan Pharmaceuticals is issuing a voluntary recall of one batch of insulin glargine injection due to the potential for a missing label in the batch.

Mylan Pharmaceuticals Issues Voluntary Recall of Insulin Glargine Injection

ReiThera, a biotech company focused on genetic vaccines and medicinal products for advanced therapies, and Exothera, a contract development and manufacturing organization (CDMO), announced on April 12, 2022 a collaboration agreement to develop a manufacturing process that allows for the large-scale, low cost production of ReiThera’s novel vaccines.

The collaboration will be funded by a €3 million grant awarded by the Bill & Melinda Gates Foundation. The companies will focus on delivering vaccines against COVID-19 and HIV, among others, to low and middle-income countries (LMIC) in Africa by developing a new low-cost approach based on ReiThera’s GRAd technology platform. Many low and middle-income countries are struggling to secure access to vaccines and adequate supplies, making aid in immunization efforts increasingly impactful.

“This collaboration with Exothera is an important step in providing ReiThera’s novel vaccines for further study in a range of serious diseases, and in particular for seeking a solution that makes these vaccines more readily available once approved to people in LMIC regions,” said Stefano Colloca, chief technology officer and co-founder of ReiThera, in a press release. “This second Bill & Melinda Gates Foundation grant, following an initial grant to ReiThera in November 2021 to support the development of the GRAd platform, provides further validation of ReiThera’s innovative technology and underscores our technical expertise in clinical manufacturing and bio-risk management.”

“ReiThera’s innovative GRAd platform technology paired with Exothera’s process development and scaling-up know-how has the potential to make important vaccines available for all,” added José Castillo, Exothera’s chairman, in the release. “Combining our process know-how with Univercells Technologies’ Nevoline will provide Low- and Middle-Income countries with access to much needed solutions for unmet medical needs such as HIV as well as against the current global pandemic.”

ReiThera and Exothera are collaborating to develop a large-scale, low-cost-per-dose manufacturing process to deliver novel vaccines to low and middle-income countries.

ReiThera and Exothera Collaborate on Manufacturing Vaccines for Low and Middle-income Countries

Achilles Therapeutics, a clinical-stage biopharmaceutical company, announced on April 12, 2022 that it is expanding its clinical manufacturing capabilities in the United Kingdom and the United States. The company’s manufacturing facility in Stevenage, UK, has received a manufacturing license from the UK Medicines and Healthcare products Regulatory Agency (MHRA), as well as entered into a partnership agreement for clinical manufacturing with the Center for Breakthrough Medicines (CBM), a contract development and manufacturing organization (CDMO) based in Pennsylvania.

Following the receipt of the manufacturing license from the MHRA, the Stevenage facility is now good manufacturing practice (GMP) certified to produce clinical-grade doses of cNeT, the company’s personalized clonal neoantigen-reactive T cell product candidates. This facility will have an annual capacity of 200 cNeT doses at peak production. The company’s first US GMP manufacturing facility will be operated by CBM in King of Prussia, Pennsylvania, and will have an initial annual capacity of 150–200 doses at peak production.

“This significant scale up in annual capacity and expansion of our global clinical manufacturing footprint, with our second site in the UK and our first site to be established in the US, significantly strengthens our global clinical, technical, and supply chain operations,” said Edward Samuel, executive vice president of Technical Operations at Achilles Therapeutics, in a press release.

Achilles Therapeutics has announced that it will expand its clinical manufacturing capabilities in the UK and enter a partnership agreement for expansion in the US.

Achilles Therapeutics Announces Manufacturing Expansion in the UK and US

Novavax announced on April 13, 2022 that its COVID-19 vaccine Nuvaxovid has been granted conditional marketing authorization by Swissmedic, the Swiss Agency for Therapeutic Products, for active immunization to prevent COVID-19 in individuals aged 18 years or older. The vaccine will be the first protein-based COVID-19 vaccine authorized for use in Switzerland.

Novavax previously had an agreement with the government of Switzerland for up to six million doses of Novavax’ COVID-19 vaccine. The vaccine is a protein-based vaccine created using Novavax’ recombinant nanoparticle technology. Novavax has established partnerships for the manufacture, commercialization, and distribution of its vaccine worldwide. Existing authorizations leverage the company’s manufacturing parentship with Serum Institute of India, the world’s largest vaccine manufacturer by volume.

"We are proud that Switzerland is part of the growing list of countries to authorize Nuvaxovid and that people in Switzerland will have a protein-based COVID-19 vaccine option," said Stanley C. Erck, President and CEO of Novavax. "As we continue to fight COVID-19, we think it is incredibly important that people have a choice in vaccine options. Nuvaxovid offers something different from the current portfolio of vaccines by using a more tried and tested technology platform, while still providing a strong efficacy and safety profile."

Swissmedic grants conditional marketing authorization for Novavax COVID-19 vaccine for individuals aged 18 years or older in Switzerland. 