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VACCINE supplies are currently making headlines for all the wrong reasons as delays in deliveries from drug manufacturers have sparked rising tensions in Europe and increased concerns about “vaccine nationalism”.
While some of the delays are due to manufacturing, others relate to the fill and finish process. In an effort to explain the challenges faced, volunteers from the International Society for Pharmaceutical Engineering UK Affiliate (ISPE UK) and IChemE’s Pharmaceutical Special Interest Group have published the following guide aimed at explaining to the public the process of fill and finish, and drug product release:
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
21 dicembre 2020 13:54
Fonte: Adnkronos
#economia-e-finanza
SHANGHAI and WUPPERTAL, Germany, Dec. 21, 2020 /PRNewswire/ WuXi Biologics ( WuXi Bio ) (2269.HK), a global company with leading open-access biologics technology platforms, and Bayer, today announced an acquisition deal, under which WuXi Biologics will take over and operate the Drug Substance (DS) facility at Bayer s Wuppertal site. The companies also plan to enter into a long-term sublease agreement and a transition service contract. The volume of the transaction, including the sublease agreement, amounts to approximately 150 million euros.
The 30,000-square-meter DS facility (MFG19), including 3x1000L perfusion and 6x2000L fed-batch capacity with independent downstream suites, will further enhance WuXi Biologics global network to supply COVID-19 vaccines and other biologics. Together with the Drug Product facility in Leverkusen (DP7), this new DS facility will be used for commercial manufacturing, allowing WuXi
WuXi Biologics to Acquire Drug Substance Facility in Wuppertal, Germany from Bayer
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The DS facility (MFG19) with 3x1000L perfusion and 6x2000L fed-batch capacity for vaccines and biologics is expected to be GMP ready in late 2021
Complements WuXi Biologics existing DP capacity in Germany
Capacity expansion allows WuXi Biologics to meet growing client demand worldwide, demonstrating strong commitment to its Global Dual Sourcing strategy
SHANGHAI and WUPPERTAL, Germany, Dec. 21, 2020 /PRNewswire/ WuXi Biologics ( WuXi Bio ) (2269.HK), a global company with leading open-access biologics technology platforms, and Bayer, today announced an acquisition deal, under which WuXi Biologics will take over and operate the Drug Substance (DS) facility at Bayer s Wuppertal site. The companies also plan to enter into a long-term sublease agreement and a transition service contract. The volume of the transaction, including the sublease
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What You Need to Know: Late on December 11, 2020, the Food and Drug Administration issued the first emergency use authorization (“EUA”) for a vaccine for the prevention of COVID-19 in individuals 16 years of age and older. Under the EUA, the Pfizer-BioNTech COVID-19 Vaccine can be distributed in the U.S. and shipment has begun this weekend.
The scope of the EUA is limited as follows:
Pfizer Inc. will supply Pfizer-BioNTech COVID‑19 Vaccine either directly or through authorized distributor(s), who will distribute to emergency response stakeholders as directed by the U.S. government, including the Centers for Disease Control and Prevention (“CDC”) and/or other designee, for use consistent with the terms and conditions of this EUA;