Monday, September 28, 2020 Daily Archives

eBook: Trends in Facility Design — In-House Manufacturing Considerations for Cell and Gene Therapy Production

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Manufacturing and facility challenges facing cell and gene therapy companies are similar to but more complex than those encountered by companies that produce traditional biopharmaceuticals such as vaccines, monoclonal antibodies, and other therapeutic proteins. A single product can have multiple components, manufacturing of which may or may not be outsourced. Project timelines are short, production technologies are new and evolving, and clinical demands change rapidly. Increasing competition for contract manufacturing services requires reserving capacity far in advance, which in most…

September 28, 2020

New Data Analytics Tools Can Improve Bioprocess Workflows — If Applied Correctly

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Biotherapeutics are a hot topic right now — and for good reason. But even before the COVID-19 pandemic, the biotherapeutics field, like every other manufacturing sector, was exploding with all the data that are being generated by recent innovations in equipment, systems, and processes. Advances in biomanufacturing analytics, analytical technology, and machine learning have tried to keep pace; however, such tools too often are misunderstood and applied suboptimally. Thus, many companies struggle with confusion and missed opportunities when they should…

September 28, 2020

Three Ways to Successfully Scale-Up Your Bioprocessing Production

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When developing a biopharmaceutical manufacturing process, an R&D or process development team may fall into the trap of developing a process in the lab which is difficult to scale to work with larger volumes in production, leading to delays and costly additional development later on. It is therefore crucial that, where possible, technology is used at small-scale which can be scaled alongside the process in a consistent manner. Taking a thoughtful and strategic approach can help biopharmaceutical products get to…

September 28, 2020

Single-use tech “unstoppable†if suppliers can meet soaring demand, says GSK

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COVID-19 has further increased already soaring demand for single-use tech according to a GSK expert who says boosting supply is key. Most biopharmaceuticals are made in stainless steel systems. But the past decade has seen interest in using disposable single-use systems increase. Initially the focus was in clinical supply. However, as Weibing Ding, director of GSK Pharma in King of Prussia, Pennsylvania told BPI East virtual conference delegates, a growing number of companies are trialing single-use systems for commercial-scale production.…

September 28, 2020