Pharmaceutical Technology Editors

The dispute between the European Commission (EC) of the European Union and pharmaceutical company AstraZeneca continues, as the head of the EC, Ursula von der Leyen, calls on AstraZeneca for the publication of the confidential vaccine contract on Friday Jan. 29, 2021.

According to multiple news sources, von der Leyen has specified, in a 

 with a German station (Deutschlandfunk), that the contract between the EU and AstraZeneca is “crystal clear” and contains “binding orders.” The dispute concerns the reduced supply of the AstraZeneca/Oxford COVID-19 vaccine to the EU, which is being attributed to production issues at plants in the Netherlands and Belgium.

Currently, AstraZeneca has revealed that it will only be able to supply a quarter of the originally agreed number of doses before the end of March as a result of the production problems being faced at the European plants. However, EU Health Commissioner, Stella Kyriakides, has insisted that the company utilize production facilities in the United Kingdom to help meet their contractual obligement for doses to the EU.

Pascal Soriot, CEO of AstraZeneca, has been quoted in 

 an Italian newspaper, on Jan. 26, 2021 as stating that the contract between the company and the EU only specifies the company makes its best effort to provide the doses of vaccine, rather than a guarantee for a set number of doses in a given deadline. “It's not a commitment we have to Europe: it’s a best effort, we said we are going to make our best effort,” he said.

 published on EC’s website on Jan. 27, 2021, Kyriakides responded by specifying, “The view that the company is not obliged to deliver because we signed a ‘best effort' agreement is neither correct nor is it acceptable. We signed an Advance Purchase Agreement for a product which at the time did not exist, and which still today is not yet authorised. And we signed it precisely to ensure that the company builds the manufacturing capacity to produce the vaccine early, so that they can deliver a certain volume of doses the day that it is authorized.”

At the time of writing, the AstraZeneca/Oxford vaccine has not received regulatory approval in Europe.

Articles

The dispute between the European Commission (EC) of the European Union and pharmaceutical company AstraZeneca continues.



Vaccine Supply Dispute Between EU and AstraZeneca Continues

Biotechnology company, Polyplus-transfection, has announced in a Jan. 27, 2021 press release that it has started construction of a new facility in France to meet growth in the cell and gene therapy market.

 and will house the company’s head office. Several immediate priorities will be fulfilled for the company upon the completion of the new facility, including doubling of the company’s headcount. Additionally, the new facility will provide additional manufacturing capacity for 

“The gene and cell therapy market continues to grow at a high rate, with more late-stage clinical trials moving towards commercialization, additionally supported by an increase in earlier stage therapies moving into the clinic. As a supplier of critical strategic materials for the sector, Polyplus-transfection will continue to invest to increase its capabilities and support its global customer base,” said Mario Philips, CEO, Polyplus-transfection, in the press release.

According to the company, the facility is expected to be operational in the third quarter of 2021.

Biotechnology company, Polyplus-transfection, has started construction of a new facility in France to meet growth in the cell and gene therapy market.

Polyplus-transfection Commences Build of New Facility

The European Medicines Agency (EMA) has issued the first safety update on a COVID-19 vaccine—Comirnaty (Pfizer/BioNTech vaccine)—according to a Jan. 29, 2020 press release.

Reflecting data collected and assessed since the regulatory authorization of Comirnaty, the safety update concludes that the safety of the vaccine as seen in vaccination campaigns is consistent with the known safety profile, with no new side effects identified. Data from EudraVigilance along with data from other sources, such as the company’s monthly safety report, have been included in the update.

Additionally, the update includes the assessment by EMA’s safety committee (PRAC) on the number of deaths reported after vaccination with Comirnaty. According to its assessment, PRAC found that the data did not show a link between the vaccination and cases of death, and the number of cases did not raise a safety concern.

EMA reported in the release that the safety and effectiveness of Comirnaty will be continually monitored as it is used across Europe and globally through its pharmacovigilance system.

The European Medicines Agency (EMA) has issued the first safety update on a COVID-19 vaccine—Comirnaty (Pfizer/BioNTech vaccine).

EMA Publishes Vaccine Safety Update on Comirnaty

The BioIndustry Association (BIA) has welcomed the announcement from the government of the United Kingdom that genomics expertise and capacity will be offered globally to help identify new variants of the virus that cause COVID-19.

Matt Hancock, secretary of state for Health and Social Care, revealed the plans for the UK to provide global support to sequence the full genetic code of the COVID-19 virus in an announcement on Jan. 26, 2021. The provision of expertise and capacity will be offered to countries that do not have resources to analyze new strains and will be run through the New Variant Assessment Platform, which is to be led by Public Health England.

“This pandemic has shown that the foundations of so many of the exciting experiences that make life worth living are contingent not just on our health, or the health of our neighbors, but the health of people across the world. The new variants of coronavirus have demonstrated [the importance of global health] once again so we must work to promote health security right across the world,” Hancock said in the announcement. “Our New Variant Assessment Platform will help us better understand this virus and how it spreads and will also boost global capacity to understand coronavirus so we’re all better prepared for whatever lies ahead.”

In response to the announcement, Steve Bates, CEO of BIA, said in a Jan. 26, 2021 press release, “The rapid genetic sequencing and identification of new COVID-19 variants that the New Variant Assessment Platform announced today promises not only to inform public health measures but is also the bedrock of novel vaccine discovery and development. Life science companies in the UK look forward to sharing their industrial expertise and capability with Public Health England’s new platform enabling the UK innovation ecosystem to contribute scalable vaccine development to the globe. Immediate opportunities are likely to be in innovative mRNA platforms, rapidly adaptable to vaccines for potential future variants.”

BIA has welcomed the announcement from the UK government that genomics expertise and capacity will be offered globally to help identify new variants of the virus that cause COVID-19.

Industry Welcomes UK’s Offer to Provide Genomics Expertise to Identify New COVID Variants

On Jan. 27, 2021, Cytiva announced the launch of HiScreen Fibro PrismA, the newest product available for early monoclonal antibody (mAb) purification process development. The product complements HiTrap Fibro PrismA, the company’s new fiber-bases Protein A platform launched for research applications in 2020.

The Fibro technology features an open porous adsorbent material comprising cellulose fibers designed for rapid mass transfer. Fibro PrismA uses the same chromatography systems, infrastructure, and ligands as resin chromatography, which allows for simple transition into existing biomanufacturing facilities.

The Fibro technology enables rapid cycling chromatography, which accelerates research and process development, and increases productivity in large-scale manufacturing. The technology involves the combination of high resin-binding capacity and the high flow rates of membranes in a scalable product that enables hundreds of cycles to be run in a single day, translating to a 20-fold increase in productivity for single-use manufacturing. The time savings creates substantial cost savings and helps bring therapies to market faster, Cytiva said in a company press release. The technology has been selected and is currently used by more than 300 academic labs and biomanufacturers.

“Capture purification with Fibro PrismA technology is a lot faster than it is with classic Protein A resin columns and allows us to speed up our workflow. The product quality is comparable to resin purification and the eluate is more concentrated. This is a great technology that allows rapid [P]rotein A purification and saves precious time, while maintaining the product quality we are used to from resin Protein A purification,” said Katja Rüger, researcher with Teneobio, in the press release.

“Fibro PrismA technology could be the largest improvement to mAb platforms over the past decade. Using Ology Bio’s mAb platform, we have gained two orders of magnitude greater productivity using Fibro PrismA than MabSelect PrismA resin,” said Ryan Davis, senior scientist at Ology Biosciences, in the press release.

“We’ve raised the bar with our new Fibro technology. Fibro Prism A represents a step-change in performance that could really accelerate the development and manufacture of monoclonal antibodies. With the introduction of fiber chromatography, our customers can choose between fiber and resin chromatography technologies that offer both high performance and proven reliability,” added Olivier Loeillot, vice-president, Cytiva, in the press release.

The launch of HiScreen Fibro PrismA, the company’s newest product for early mAb purification process development strengthens Cytiva’s new fiber-based Protein A platform.

Cytiva Advances Fiber Chromatography Technology with New Launch

BHS-Sonthofen announced on Jan. 26, 2021 that AVA, a mechanical engineering company BHS-Sonthofen acquired in 2018, and its filtration technology division have been combined and are now operating jointly under the name BHS-Sonthofen Process Technology.

According to a company press release, the new division will provide system solutions and individual machines and components. The combination will also give the company the opportunity to expand its range of solutions and consulting services regarding mixing, drying, granulation, sterilization, and reaction.

“We have fully repositioned the company with three business units, building materials machinery, recycling and environment, and process technology,” said Dennis Kemmann, CEO of BHS-Sonthofen, in the press release. “Each of the business units serves specific industries. We work in partnership with customers primarily from the chemical and pharmaceutical industries, but also from the food production and other sectors, to develop process technology solutions.”

The new division will provide system solutions and individual machines and components.