Search results for "outsourcing"
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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.
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Biopharma Advances Demand Specialized Expertise
Also, the increasing trend toward outsourcing of GMP biologics manufacturing ensures bioprocessing and testing is performed by expert manufacturers with proven track records in quality and biomanufact…
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Buffer Management Solutions for Large-Scale Biomanufacturing
This article discusses solutions such as inline conditioning, outsourcing buffer preparation, and more.
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Automation Trend in Fill/Finish Reduces Contamination Risk
Other important trends in fill/finish identified by BioPlan Associates include the adoption of single-use/disposable equipment, improved process lines/equipment, increased outsourcing to contract manu…
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Being Thorough When Transferring Technology
BioPharm: What challenges and/or considerations must be addressed when outsourcing tech transfer and scale up?
Moscariello and Young (CMC Biologics): In process development, it is important to con…
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Aseptic Processing: Keeping it Safe
…t more regulatory control over drugs produced by state-licensed pharmacies, federal facilities, and outsourcing facilities. The documents released by the agency state that medications compounded in a…
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Drug Discovery and Development in India
Changes in the regulatory environment in the same year led to other developments with the emergence of the country as a favorite destination for “chemistry” outsourcing followed by “collaborative drug…
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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)…
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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…
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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…