February 16, 2021
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BioNTech has begun producing active ingredients in the COVID-19 vaccine the firm developed with Pfizer at a new facility and expects to make about 250 million doses at the plant in the first half of 2021, eventually scaling up to 750 million doses a year. BioNTech is making messenger RNA and adding lipid nanoparticles at the Marburg, Germany, plant it bought last year from Novartis, then shipping the product to a sterile site for completion.
Full Story: Deutsche Welle (Germany) (2/10) 
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Process development and manufacturing
Israel-based Teva Pharmaceutical Industries is negotiating with makers of approved and late-stage COVID-19 vaccines for co-production, says CEO Kare Schultz. "In principle, we are positive towards contributing by manufacturing some of those vaccines that either have been approved or are just about to be approved," Schultz says.
Full Story: Reuters (2/10) 
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Facilities and equipment
Germany-based contract development and manufacturing organization Rentschler Biopharma is investing in the Cell and Gene Therapy Catapult facility in Stevenage, UK. The investment will give Rentschler manufacturing capability in advanced therapies such as adeno-associated virus vectors.
Full Story: PharmaTimes online (UK) (2/11) 
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Vigene Biosciences is leasing 52,000 square feet of manufacturing space near its headquarters in Rockville, Md., bringing total cell and gene therapy lab and production space to 110,000 square feet, including two 2,000-liter single-use bioreactor suites and multiple large-scale fermenters for plasma, says Chief Commercial Officer Jeffrey Hung. Altimmune has contracted Vigene to produce components for clinical studies of a nasal COVID-19 vaccine, which is on hold pending protocol modifications and additional regulatory submissions.
Full Story: FiercePharma (2/11) 
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TCG GreenChem, a new contract drug manufacturing subsidiary of India-based TCG Lifesciences, has secured 3,000 square feet of lab space at Virginia Commonwealth University's Biotechnology Research Park and 54,000 square feet of lab and office space at Princeton South Corporate Center in New Jersey. The CDMO will make active pharmaceutical ingredients, including for COVID-19 antivirals.
Full Story: Endpoints News (free registration) (2/11) 
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Sanofi is selling the former Genzyme biomanufacturing plant in Allston, Mass., to National Resilience and moving manufacturing to its Framingham site. Resilience, a San Diego-based contract manufacturer, will continue making products at the plant for Sanofi through the end of the year.
Full Story: The Boston Globe (tiered subscription model) (2/10) 
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Information systems
The SolarWinds megahack compromised networks worldwide and highlighted the fragile state of enterprise security that allows a "moderately skilled attacker [to] decimate an internal corporate network long before they are discovered," writes Thinkst founder Haroon Meer. Enterprise networks that have multiple components cobbled together offer hiding places for attackers, and customers should demand more of their IT vendors, Meer writes.
Full Story: ZDNet (2/10) 
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Supply chain management
ReiThera, a small biotech company near Rome, recently finished a small trial of a COVID-19 vaccine and is competing with larger producers for critical materials, such as single-use bags and glass vials, says Stefano Colloca, chief technology officer. Italy has invested about $98 million in the company, and ReiThera is collaborating with Germany-based Leukocare and Belgium-based Univercells on its vaccine or to help produce a vaccine for another company, says Leukocare CEO Michael Scholl.
Full Story: The Washington Post (tiered subscription model) (2/13),  Reuters (2/15) 
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Quality and regulatory issues
Allay Pharmaceuticals has failed to show it corrected problems at its tablet manufacturing facility in Hialeah, Fla., uncovered in a May inspection, according to a warning letter from the US FDA, which recommended hiring a consultant. The agency found problems with blending that resulted in inconsistent potency, active pharmaceutical ingredient testing inconsistencies and production of biologic drugs without FDA approval.
Full Story: Regulatory Focus (2/12),  FiercePharma (2/10) 
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ISPE update
The usual form for modern vaccines is a liquid (normally sterile water) containing a number of identical fragments of the organism, protein or RNA strand which the body's immune system will use to train itself to identify the real organism and build antibodies to fight the infection. This liquid and a few chemical additives to help keep things stable are altogether called the vaccine. Full Story: ISPE
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Health authorities and regulators are increasingly looking for much higher levels of traceability during the manufacture of parenteral medicines as modern manufacturing operations are now becoming increasingly complex processes. Today, if a problem is identified during a process step, manufacturers are unable to define exactly which products may have been impacted. As a result, they adopt either an "over segregation" or "full batch write-off" policy. Full Story: iSpeak
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