January 25, 2022
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Pharmaceutical supplies such as glass vials were reprioritized in response to the COVID-19 pandemic, and biopharmaceutical manufacturers must try to predict supply needs accurately, maintain inventory and prequalify alternative sources, says Genezen founder Bill Vincent. A focus on sustainability, the rise of novel therapeutics and technologies, demand for speed, a shortage of skilled labor and precision medicine will also present challenges for manufacturers this year, industry leaders say.
Full Story: European Pharmaceutical Review (UK) (1/19) 
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Process development and manufacturing
The market is growing for small-batch biopharmaceutical products such as complex bispecific antibodies and rare disease therapies, and modern perfusion processes and small bioreactors might offer cost advantages and geographic flexibility, says Trent Munro of the University of Queensland's National Biologics Facility. "Rather than automatically defaulting to a large-scale fed-batch commercial process, we will see molecules being developed with a fit-for-purpose strategy, in terms of both scale and process," Munro said.
Full Story: Genetic Engineering & Biotechnology News (1/19) 
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Lex Rovner, who earned a doctorate at Yale University, is the CEO of Yale spinout 64x, whose VectorSelect machine learning platform analyzes cell lines to determine how well viruses would grow in them, then analyzes gene combinations that make cells highly productive as viral vector factories. Rovner developed the technology after learning about a capacity shortage in viral vector manufacturing that limits the availability of promising therapies.
Full Story: Endpoints News (free registration) (1/19) 
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Center for Breakthrough Medicines will gain commercial rights to certain gene therapy manufacturing and analytics technology in a five-year collaboration with the University of Pennsylvania to help biotechnology companies and universities develop gene therapies.
Full Story: BioProcess International (1/20) 
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Facilities and equipment
Moderna is slated to announce possibly by "next month or so" in which African country it will set up its fill-finish facility to produce COVID-19 vaccines, according to Shannon Klinger, the company's chief legal officer. Moderna forecasts that fill-finish production could begin as soon as next year.
Full Story: Reuters (1/20) 
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GlaxoSmithKline and its partner Vir Biotechnology are set to scale up production of their COVID-19 treatment sotrovimab with the addition of a second manufacturing facility in response to increasing demand for the drug in the US, a move that GSK says was planned before the emergence of the Omicron variant. The companies recently finalized a deal with the US to supply 600,000 additional doses of sotrovimab for an undisclosed amount.
Full Story: Reuters (1/21) 
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UK-based Ori Biotech will build out its quality system, supply chain and manufacturing capacity and hire additional personnel after raising more than $100 million in a Series B financing round, CEO Jason Foster says. The company is automating, digitizing and standardizing the cell and gene therapy manufacturing process, starting at the preclinical stage, to increase throughput, improve quality and reduce costs.
Full Story: Endpoints News (free registration) (1/18) 
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Supply chain management
The Medicines Patent Pool, backed by the UN, said on Thursday that Merck will allow production of the COVID-19 pill molnupiravir, co-developed with Ridgeback Therapeutics, by 27 generic drugmakers so that the drug can be more widely available in 105 developing countries. The agreements with the companies stipulate that they may produce both the drug's raw ingredients and the final product.
Full Story: The Hill (1/20) 
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Carbon capture and storage – and the economy
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Quality and regulatory issues
Mylan Pharmaceuticals is recalling one batch of its Semglee prefilled insulin injection pens due to missing labels. The affected products carry the batch number BF20003118 and have an August 2022 expiration date.
Full Story: The News & Observer (Raleigh, N.C.) (tiered subscription model) (1/20) 
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Research and development
Scientists at the University of Massachusetts Lowell received a one-year, $930,223 grant from the National Institute for Innovation in Manufacturing Biopharmaceuticals to support development of a process to freeze dry messenger RNA vaccines. Lyophilization would enable room-temperature storage and extend shelf life, facilitating the use of mRNA COVID-19 vaccines where cold storage is a challenge and enabling the establishment of stockpiles.
Full Story: European Pharmaceutical Review (UK) (1/24) 
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ISPE update
During the past decade, industry has experienced a proliferation of regulatory divergence regarding the interpretation and implementation of International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines (and control strategies) across geographic regions. See the data that highlight instances where well-established ICH regulatory members diverge from ICH quality guidance in their evaluation of the same scientific data in chemistry, manufacturing, and controls (CMC) regulatory documents submitted by industry. LEARN MORE: Pharmaceutical Engineering
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ISPE announced the release of the ISPE Good Practice Guide: Controlled Temperature Chambers - Commissioning and Qualification, Mapping and Monitoring (Second Edition). This Guide was written to meet changing industry practices, as global distribution of medicines requiring controlled temperatures has increased in complexity since the first edition of this Guide was published. LEARN MORE: ISPE
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