Pharmaceutical Technology Editors

Pfizer and BioNTech announced results from an initial laboratory study concerning the effects of the Pfizer-BioNTech COVID-19 Vaccine on the SARS-CoV-2 Omicron variant on Dec. 8, 2021. The study found that individuals who received two doses of the current COVID-19 vaccine exhibited a more than 25-fold reduction in neutralization titers against the Omicron variant.

However, while the vaccine showed reduced effectivity against the Omicron variant in individuals who received two doses, those who received three doses fared much better. The study found that those who received a third dose (i.e., a booster vaccination) neutralized the Omicron variant to levels comparable to those observed for the wild-type SARS-CoV-2 spike protein after two doses.

Additionally, the results found that a third dose strongly increased CD8+ T cell levels against multiple spike protein epitopes; this increase in T cell levels is considered to correlate with protection against severe disease. Compared to the wild-type virus, the vast majority of these epitopes remain unchanged in the Omicron spike variant.

“Although two doses of the vaccine may still offer protection against severe disease caused by the Omicron strain, it’s clear from these preliminary data that protection is improved with a third dose of our vaccine,” said Albert Bourla, chairman and CEO, Pfizer, in a company press release. “Ensuring as many people as possible are fully vaccinated with the first two-dose series and a booster remains the best course of action to prevent the spread of COVID-19.”

The companies began development of an Omicron-specific COVID-19 vaccine on Nov. 25, 2021, the development of which will continue as planned in the event that a vaccine adaption is needed to increase the level and duration of protection against Omicron. These vaccines are planned to be ready for delivery within 100 days, pending regulatory approval.

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Pfizer found that two-dose recipients exhibited a more than 25-fold reduction in neutralization titers against Omicron relative to wild-type.

Pfizer and BioNTech Provide Update on Omicron Variant

Lonza announced on Dec. 8, 2021 that it has entered into a research license agreement with Zhejiang Doer Biologics, a clinical-stage biopharmaceutical company, under which Doer may use Lonza’s XS technology for the production of its proprietary platform technology.

According to a company press release, Lonza’s XS Pichia Expression System enables scalable, robust, and reliable expression processes. Doer plans to use the technology to develop, express, and manufacture multi-specific Volatile Halogenated Hydrocarbons (VHH)-based biotherapeutic proteins with the intent of addressing unmet immuno-oncology needs.

“Next-generation therapies always demand a new take on expression systems,” said Peter Droc, head of Licensing and Drug Product Services, Lonza, in the press release. “At Lonza, we have continued developing a toolbox of expression systems that help accommodate industry trends, eliminate production bottlenecks, align downstream processing, and drive breakthroughs in the clinic. Doer Biologics has innovative R&D pipelines for VHH antibodies and we believe this agreement will further accelerate their candidates from pre-clinical study to commercial manufacturing.”

“Designing and developing new multi-specific antibodies represents a central challenge for the realization of new immunotherapies,” said Yanshan Huang, founder and CEO, Zhejiang Doer Biologics, in the press release. “Access to Lonza’s proprietary expression technology will enable us to progress our proprietary MultipleBody and SMART-VHHBody platform by providing high-yielding processes for our candidates. We believe that we can develop high-quality VHH-based multi-specific biotherapeutics in a faster and lower-cost fashion with Lonza’s XS Pichia Expression System.”

Doer Biologics will use Lonza’s XS technology in the production of its proprietary platform technology.

Lonza Signs Biotherapeutics Licensing Agreement with Doer Biologics

Fujifilm Irvine Scientific announced on Dec. 8, 2021, that it’s new manufacturing facility in Tilburg, the Netherlands, is now open and fully operational. This life science manufacturing facility joins existing locations in the United States and Japan to enable increased production capacity of cell culture media products.

The facility occupies approximately 13,500 m² of space previously used to manufacture film rolls. It manufactures dry powder media, liquid media, buffers, and water for injection. At present, it will increase production capacity with approximately 320,000 kg/year of dry powder media and more than 470,000 L/year of liquids, while also having the physical capacity to expand further.

Fujifilm’s long-term plan is to secure requisite production capacity to meet the growing needs of the market and customers worldwide. By placing their third facility in central Europe, it can act as a hub. The facility can not only be a source of local supply, increasing efficiency and cost-savings in shipping, but also secure the supply chain.

"We worked steadily to achieve milestones for construction, validation, and commissioning of this manufacturing facility," said Yutaka Yamaguchi, chairman and CEO, Fujifilm Irvine Scientific, in the press release. "Even with the global challenges faced in recent years, [Fujifilm] Irvine Scientific was determined to provide customers in Europe with local service that strengthens the supply chain and increases manufacturing capacity. It is extremely rewarding to see this commitment realized."

The site is working towards a CO2-neutral status, using wind energy for the product process, and using sustainable technologies such as membrane bioreactors for wastewater purification. It intends to become an International Organization for Standardization 13485 certified manufacturing facility and follow Current Good Manufacturing Practices, 21 Code of Federal Regulations 820 for product manufacturing.

Fujifilm’s new cell culture media manufacturing facility in the Netherlands has officially opened.

Fujifilm Irvine Scientific Opens European Manufacturing Facility

Crown Bioscience, a contract research organization, announced that it had completed the expansion and renovation of its United Kingdom facility on Dec. 7, 2021. The site, which already featured comprehensive 

 models (including orthotopic, metastatic, and systemic variations), now incorporates additional laboratory and office space that will increase capacity and expand the company’s current 

The new expansion also provides dedicated space for a newly acquired high frequency ultrasound unit. This specialized high-resolution imaging device is designed to increase the utility of two- and three-dimensional imaging without the need for cell line-tagging. According to a company press release, it also enables high precision guided inoculation/dosing of orthotopic and metastatic models. Furthermore, the company states that it will enable better longitudinal evaluation of tumor growth, as well as earlier, more detailed analytics on the tumor microenvironment.

“This expansion is a critical step in our ability to provide additional imaging modalities to better visualize and understand tumor progression and response to potential therapies,” said Yinfei Yin, general manager at Crown Bioscience UK, in the press release. “This additional imaging platform allows us to perform cutting-edge preclinical studies, offering our customers advanced insights on potential drug candidates before they enter clinical trials.”

“This site expansion is driven by increased customer demand for access to Crown Bioscience’s 

 services from the UK and mainland Europe, and allows us to build upon our innovative foundation to develop additional industry-leading technologies,” said Armin Spura, CEO of Crown Bioscience, in the press release. “Following our recent acquisition of OcellO B.V. and launch of our 3D 

 Patient Tissue Platform, this milestone enables Crown Bioscience to continue to use the power of partnership to unlock breakthroughs in drug discovery and, ultimately, to provide patients with better treatment options.”

The additions to Crown Bioscience’s UK facility will increase and expand the company’s current in-vivo offering.

Crown Bioscience Expands In-Vivo Capacity at UK Facility

Roche announced that the European Union (EU) approved an extension of its marketing authorization for Actemra/RoActemra (tocilizumab) to include treatment of severe COVID-19 on Dec. 7, 2021. Tocilizumab can now be used as a treatment for adults with COVID-19 who are receiving systemic corticosteroids and require supplemental oxygen or mechanical ventilation.

Tocilizumab received an accelerated assessment from The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP). Just hours after CHMP issued a recommendation favoring it, the EU approved the drug’s extended marketing authorization.

“[Tocilizumab] is the second Roche medicine to have received rapid European Commission approval in COVID-19 in recent weeks,” said Levi Garraway, Roche’s chief medical officer and head of Global Product Development, in a company press release. “The totality of evidence shows that [tocilizumab] can benefit those suffering with severe COVID-19. Together with vaccines, other treatments and testing, [tocilizumab] forms an important piece of the care puzzle as we confront new challenges of the pandemic in Europe and around the world.”

Tocilizumab is an anti-IL-6 receptor biologic, available in both intravenous and subcutaneous formulations, that was originally used in the treatment of moderate-to-severe active rheumatoid arthritis. According to the press release, in addition to the EU, it is provisionally approved in Australia, authorized for emergency use in the United States and Ghana, and recommended by the World Health Organization (WHO) for the treatment of COVID-19.

Roche’s Actemra/RoActemra (tocilizumab) is now approved in the EU for the treatment of adults with severe COVID-19 symptoms.

EU Approves Roche’s Treatment for Severe COVID-19

AstraZeneca announced on Dec. 7, 2021, that it would pay $200 million to Ionis Pharmaceuticals for the rights to its investigational medicine, eplontersen. Per the terms of the deal, if certain regulatory and sales thresholds are met, AstraZeneca could pay an additional $3.385 billion to Ionis.

Eplontersen is a ligand-conjugated antisense investigational medicine currently in Phase III clinical trials for amyloid transthyretin cardiomyopathy and amyloid transthyretin polyneuropathy. It is designed to reduce the production of transthyretin (TTR) to treat both hereditary and non-hereditary forms of TTR amyloidosis (ATTR).

ATTR is a very rare form of amyloidosis caused by misfolding TTR proteins, resulting in interference to normal function in peripheral nerves, heart, gastrointestinal system, eyes, kidneys, central nervous system, thyroid, or bone marrow tissues. It is a progressive, systematic, and ultimately fatal disease; according to a company press release, it typically results in progressive heart failure within four years of diagnosis.

“Eplontersen has the potential to halt the progression of TTR-mediated amyloidosis, irrespective of whether it’s caused by genetic mutations or aging,” said Mene Pangalos, executive vice-president, BioPharmaceuticals R&D, AstraZeneca, in the press release. “Thanks to its precise liver-targeting properties, it also has the potential to be a best-in-class treatment for patients suffering from this devastating disease and who currently have limited options.”

AstraZeneca struck a deal worth up to more than $3.5 billion with Ionis Pharmaceuticals for the rights to develop and commercialize their transthyretin (TTR) amyloidosis treatment.