Search results for " 2020"

Article Enhancing Resins Addresses Purification Concerns
29, 2020. 3. N. El-Hajjami, “Plasmid DNA Production for Cell and Gene Therapy,” Cell Culture DISH, Nov. 30, 2020. 4. M. Urabe, et al., Molecular Therapy 13 (4) 823–828 (2006). Ab…

Article Maximum Output Starts with Optimized Upstream Processing
“Prior to the pandemic, large investments in capacity were being put in place with the likes of Cobra Biologics in the UK completing its viral vector production expansion in 2020 and with other signif…

Article Genetic Vaccine Platforms Demonstrate Their Potential
This situation has started to change with FDA granting Emergency Use Authorizations to the mRNA vaccines from Pfizer-BioNTech and Moderna for COVID-19 in late 2020 and approval for the viral-vector va…

Article Reimagining Affordable Biosimilars
Advances in preclinical development play a crucial role in reducing cost for developing biosimilars.  By Anurag S. Rathore, Narendra Chirmule, and Himanshu Malani  Drug development is …

Article Improving Upstream Predictability
One showcase will be Amgen’s facility in West Greenwich, RI, construction of which is expected to be completed in 2020 (1). Leveraging PAT and sensor technology, it will feature a modular design and u…

Article ADC Development Robust Despite Lackluster Performance
The company plans to submit regulatory filings for these indications in 2020 or later (11). In addition to these combination-use clinical trials, Roche is also conducting two Phase III clinical…

Article Biopharma in 2016: Higher Quality Drugs, Less Expensive Manufacturing
Analysts expect the worldwide biosimilars market to reach $25 billion to $35 billion by 2020.2 Many experts recall Trump’s criticism of high drug prices and expect that he will try to control pricing …

Article Framing Biopharma Success in 2016
Corporate restructurings, regulatory initiatives, and biosimilars will shape biopharma development in 2016. By Rita C. Peters The US biopharmaceutical industry turned a new page in 2015 when…

Article Sterilization Trends for Single-Use Consumables
BPSA published background and risk-based testing strategies for SU systems in 2020 (10) and a second paper in 2023 sharing data on a variety of components from multiple suppliers and test labs all ind…

Article Evaluating the Use of Continuous Chromatography
Continuous processes continue to advance in bioprocessing. In downstream processing, continuous chromatography is gaining traction in the purification of protein therapeutics. As the biopharma…

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