Defining and Presenting Overkill Cycle Validation
Sterilization validation must be based on a robust, quality-by-design philosophy; autoclave overkill cycles should be validated by correlating lethality data to support chosen critical process parameters, even when using overkill sterilization.

Disposable Applications in Demand by Biopharma
Data from BioPlan Associates’ 10th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production suggest that the interest in disposable devices has begun to extend to biopharma operations beyond basic single-use bags and connectors.

European Union Introduces GMPs for Excipients
Regulators hope new standards will stop illegal drug imports, but manufacturers fear they may stifle innovation.

Video: Paving the Way for Therapeutic Vaccines
John J. Castellani, President and CEO of the Pharmaceutical Research and Manufacturers of America of the PhRMA Research & Hope awards and creating an ecosystem for promoting new vaccine development.

Where’s the Vaccine for Meningitis B?
The bacterial meningitis outbreak at Princeton University in recent weeks has raised questions about why there is no vaccine in the United States to prevent this deadly disease, and illustrates the complexities of vaccine development, approval and reimbursement at home and abroad.

GlaxoSmithKline Invests in India
GlaxoSmithKline will build a new solid dosage manufacturing facility in India.

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Pharmaceutical Industry Growth Rebounds in Five-Year Outlook
Annual growth in spending for medicines is expected to rise from 2-3% in 2013 to 5-7% in 2017, the highest pace of growth since 2009.

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Merck KGaA Invests in China, Global HQ
Merck KGaA plans to build a new biomanufacturing facility in Nantong, China.

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Catalent Signs RL21 Anti-Cancer Development Deal with Pure MHC
Catalent has signed a product development agreement with immunology company Pure MHC (major histocompatibility complex), which specializes in MHC-based diagnostics and therapeutics.

Pfizer and GlaxoSmithKline Form Pact in Combination Cancer Trial
Phase I/II study to evaluate treatment of patients with melanoma using Pfizer’s and GSK’s trametinib.

Unilife to Supply Hikma with Prefilled Syringes for Generic Injectables
Unilife to begin commercial supply in 2014.

EMA Signs 3-Year Work Plan with EUnetHTA
Plan outlines key areas of collaboration.

Xcelience Appoints Clinical Supplies VP of New UK Site
Xcelience appoints Clinical Supplies VP of its new Birmingham, United Kingdom site.

Pfizer to Close Manufacturing Plant in Puerto Rico by 2017
Manufacturing of products made at the Barceloneta, Puerto Rico plant will be moved to other sites.

CareFusion Expands Specialty Disposables Business with Acquisition from GE Healthcare
CareFusion will acquire GE Healthcare’s Vital Signs division.