Search results for " 2020"

Article Bracing for a Future Wave of Advanced Therapies
With the help of recent investor interest, progression of advanced therapy medicinal products (ATMPs) in the clinical space continues to move forward. Buoyed by the regulatory approval of sever…

Article Report from the 12th Plasma Product Biotechnology Forum
One of the consequences during the lockdown beginning in 2020 was an acute decline in plasma collection, due to donors reluctant to leave their homes, plus also negative effects from the alterations t…

Article Single-Use Technologies Prove Effective for Viral Vector Process Development
Legmann, Cytotherapy, 22(5) Supplement S151 (May 2020). 2. Clive Glover, “Rapid Development and Industrialization of a COVID-19 Viral Vector Vaccine Manufacturing Process,” Pall Biotech Blog, Jan.…

Article Commercial Production of Gene Therapies Using Suspension or Adherent Cell Lines
This article will explore the traditional path from the laboratory to the clinic and how the fixed-bed technology provides an alternative solution to meet commercial demands. By Alex Chatel and …

Article Assessing Manufacturing Process Robustness
18, 2020). About the authors Ajay Babu Pazhayattil is lead consultant, specializing in process validation, with Validant. Sanjay Sharma is vice-president and head of technology transfe…

Article Regulatory Requirements for Safe and Efficient Biologic Drug Development
FDA has issued a lot of guidance earlier in 2020 that’s affected the cell and gene manufacturing area, since we have a huge amount of research and development going on right now in there. And I think …

Article Cytiva Advances Fiber Chromatography Technology with New Launch
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 mat…

Article Remote Monitoring and Big Data Advance Upstream Automation
Connected, integrated bioprocessing enterprises with greater data analytics capabilities are coming. By Cynthia A. Challener As upstream processing drives toward higher efficiencies in meeti…

Article Virus-like Particles as Therapeutic Moieties of the Future
Analytical and functional characterization of virus-like particles enables process reproducibility and product consistency. By Ramesh Kumar, Manidipa Banerjee, Anurag S. Rathore Virus-like…

Article Cytiva and 4Tune Engineering Collaborate on Cell Therapy Quality Risk Management
3, 2020, Cytiva and 4Tune Engineering, a manufacturing-sciences and technology company, announced that they have entered into an agreement to include 4Tune Engineering’s iRISK platform in Cytiva’s cel…

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