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Article Concentrating Feed—an Applicable Approach to Improve Antibody Production
Four experimental cocktail solutions composed of cDNA synthesis reaction and SABiosciences RT2 qPCR master Mix (Qiagen) were dispensed into 4 × 96 wells (10 µL/well) in 384-well PCR unfolded protein r…

Article Challenges in Analytical Method Development and Validation
According to Yong Guo, professor of pharmaceutical sciences at the School of Pharmacy, Fairleigh Dickinson University (FDU), analytical development and cross-functional development teams should work t…

Article Q&As with Industry Leaders
…nternational  Christopher Woolstenhulme, Lead Analytical Scientist of Manufacturing Sciences, Cytiva Tools and Methodologies for Smarter Downstream Process Development Gayle S. Pu…

Article Biopharma Takes a Nervous Glance Over Its Shoulder
These factors include a competitive corporate tax rate; private funding of R&D in early stage and emerging companies; robust government investment in basic R&D; a strong R&D and science, technology, e…

Article Raw Material Variability
For the manufacturers cross-functional teams covering operations, quality control, quality assurance, purchasing, and manufacturing science are now best practice to ensure all perspectives are taken i…

Article Early Communication with Regulators is Essential for SMEs
“The people running SMEs know the science and technology of the area in which they are doing business,” explains Hooshang Zavareh, founder of ChemPharmServe, Cambridge England, a company that speciali…

Article Best Practices in Adopting Single-Use Systems
About the Author John Schmitz, director of strategy and business development, life sciences, Saint-Gobain Performance Plastics.

Article State of Quality and Compliance in the Biopharmaceutical Industry
More complexity does not make better science. Paperwork and bureaucracy have increased to a point where they impede proper functioning of the quality and production systems. Management must look for n…

Article Report from India
Sujay Shetty, executive director and India pharma life sciences leader of PricewaterhouseCoopers, comments, "As NLEM drugs account for nearly 60% of the market, value erosion of the pharmaceutical mar…

Article Quality by Design: A CMO's Perspective on Gaining Knowledge Faster and Better
Clinton Weber is associate director of BioProcess Sciences, Ashok Kumar is principal scientist, Lisa Joslin is process validation manager, and Roland Ashton, James Schmid, and Michael Larson are devel…

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