Search results for " Outsourcing" in Articles / App Notes

Article What's in Your SOP?
What’s in Your SOP? SOPs need to reflect a company’s specific manufacturing or other operations, says Susan Schniepp, distinguished fellow at Regulatory Compliance Associates. …

Article Biopharma Advances Demand Specialized Expertise
Jun 15, 2015 By BioPharm International Editors BioPharm International eBooks Volume 28, Issue 13 Contract service providers share insights on biopharma market developments and the impl…

Article Buffer Management Solutions for Large-Scale Biomanufacturing
Learn how different approaches can resolve buffer management challenges in large-scale biomanufacturing. This article discusses solutions such as inline conditioning, outsourcing buffer preparation,…

Article Automation Trend in Fill/Finish Reduces Contamination Risk
Aseptic fill/finish is crucial in biopharma manufacturing and is optimized through automated technology. By Feliza Mirasol  Aseptic filling is a crucial process in biopharmaceutical …

Article Being Thorough When Transferring Technology
Communication and taking the time to develop the process are key to successful transfer and scale up of biologics. By Susan Haigney Editor's note: The following is an extended version of the…

Article Aseptic Processing: Keeping it Safe
By Randi Hernandez, BioPharm International Humans represent the greatest risk for microbial contamination in an aseptic process. Aseptic processing has garnered some increased scrutiny…

Article Drug Discovery and Development in India
Apr 01, 2015 By Jane Wan BioPharm International Volume 28, Issue 4 Indian pharmaceutical companies’ entry into the drug discovery and development field dates back to the early 1990s …

Article Advancing QbD in the EU
EU authorities are stepping up their efforts to incorporate QbD principles. The European Commission (EC) and the European Medicines Agency (EMA), have been supporting quality-by-design (QbD)…

Article Discovering the unknown: How does in silico process development change PD scientists’ work?
In silico process development for chromatography is a paradigm-shifting approach that redefines the routine work of process development scientists. But what does it actually mean to perfor…

Article Developing oligonucleotide therapeutics with confidence
In this video, we will look at key considerations for oligo therapeutic developers entering the market, such as scalability, flexibility, regulatory concerns, insource/outsource consideratio…

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