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Biopharma News
News from biopharmaceutical companies, including mergers, acquisitions, drug approvals, drug recalls.
Biopharmaceutical Analysis
Analytical testing methods in pharma manufacturing. Chromatography, UHPLC, chiral. Near-infrared (NIR) and Raman spectroscopy. Anticounterfeiting. Dissolution testing. Cleaning validation. Extracables & leachables.
Downstream Processing
The separation and purification steps of biotech processing, including chromatography and filtration. Vaccine and monoclonal antibody (MAb) manufacturing are also found here.
Equipment, processing, and procedures for biopharmaceutical manufacturing.
Manufacturing Systems, Single-Use
The advantages and disadvantages of disposables, along with cost-benefit analyses, validation strategies, and implementation approaches.
Trends and best practices in outsourcing, including technology transfer, contract negotiation, project management, auditing providers, and the emerging markets.
Regulatory/GMP Compliance
What you need to know about regulatory compliance, good manufacturing practices (GMPs), and validation, including evolving regulatory policy and developments in biosimilars.
Upstream Processing
Protein expression, fermentation & cell culture, and plant & animal expression methods, along with process development, scale up, and technology transfer for upstream steps.
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