Defining and Presenting Overkill Cycle Validation
Autoclave overkill cycles should be validated by correlating lethality data to support chosen critical process parameters.

Disposable Applications in Demand by Biopharma
Interest in chromatography innovation continues to decline.

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Control of Elemental Impurities
The European Pharmacopoeia Commission has decided to change its approach on elemental impurities.

Video: The Impact of Biosimilars on the Innovator Market
Jill E. Sackman, D.V.M., PhD, senior consultant at Numerof & Associates, Inc. discusses the market forces impacting biopharmaceutical manufacturing.

European Medicines Agency Revises Orphan Drugs Policy
EMA revises its policies on fee reductions for orphan drugs for 2014.

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LSNE Appoints New COO
LSNE appoints Shawn Cain as COO, a new position within the company.

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New L.B. Bohle Technology Center Advances Development of Continuous Pharmaceutical Processing
Facility in Germany provides space for evaluating continuous pharmaceutical processing equipment.

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Drug Quality Screening Technology Recognized
PharmaCheck, a portable tool designed to detect poor-quality medicines, has been selected as one of the World Changing Ideas of 2013.

Wockhardt Receives FDA Warning Letter
FDA cites cGMP violations and data-integrity issues and raises concerns over the company's ability to implement a robust and sustainable quality system.

Alvotech Plans Multimillion Biosimilars Investment
Alvotech plans investment in biosimilars portfolio and manufacturing facility.

USP Labeling Standards Highlight Patient Safety
Standards for ferrules and cap overseals focus on explicit warnings.

JJHL Biotech Installs GE Healthcare FlexFactory Biomanufacturing Platform
The flexible biomanufacturing system uses single-use technology.