apceth has completed a major GMP inspection for two medicinal products. The two cell and gene therapy products are now included in the company’s GMP manufacturing license according to §13 of the German Medicines Act (AMG).

BioSC Lab is the first in a line of next-generation chromatography equipment for protein purification in batch and continuous modes.

The agency clarifies its requirements for allowable excess volume and labeled vial fill size in injectables and biologics.

Reach Separations has announced plans to double its laboratory space at its Nottingham facility as a result of increased demand for its specialist purification services.

The combined company has been created through the integration of Huntingdon Life Sciences and Harlan Laboratories announces a new company name.

A new framework featured in the Journal of Clinical Oncology will help physicians compare clinical trial results-and costs-of popular cancer medications.

Pharmaceutical Technology spoke with Monica Caphart, FDA, and Susan Schniepp, PDA, about the 2015 PDA/FDA Joint Regulatory Conference taking place in Washington, DC, in September.

The European Pharmacopoeia adopts six new texts and revises 31 monographs in its 152nd session.

Kite announces that it will collaborate with bluebird bio to develop and commercialize second-generation T-cell receptor product candidates for HPV-associated cancers.

CPhI China and co-located events bring together suppliers of raw materials, ingredients, packaging solutions, machinery, and manufacturing.

The ruling will facilitate the market entry of generic versions of Copaxone, a widely prescribed drug to treat multiple sclerosis.

The agency takes action against websites that illegally sell unapproved medications.

The International Conference on Harmonization finalizes Q&A document on APIs.

NIH provides an interim corrective action plan to correct deficiencies found in its Clinical Center Pharmaceutical Development Section.

Biomax Informatics AG and Pierre Fabre announced that they have entered into a collaboration to create an integrated antibody sequence and knowledge database.

GSK announces it will invest $95 million to launch a US-based non-profit research institute, Altius, to research technologies and approaches in understanding gene control.

EXCiPACT announces that DQS awarded Grace GmbH an EXCiPACT Certificate for its Worms, Germany excipient-manufacturing site.

The agency streamlines risk and mitigation information.

EvaluatePharma's report shows upward trends in R&D and drug approvals.

Lonza’s planned facility will be used to develop and manufacture viral gene therapies and virally modified cell therapies

The agency publishes guidance on the physical attributes of generic tablets and capsules.

MFG Tray names ChemTech International as its first Master Pharmaceutical Distributor.

A new SGS Life Science Services laboratory outside Paris is designed for bio/pharmaceutical quality control testing.

Kythera announces that it entered into a definitive agreement to be acquired by Allergan for $2.1 billion.

Careful choice of wash-water parameters and attention to water quality and basket loading are important for optimal cleaning.

Experts at Eppendorf discuss common challenges in cell culture and share insights on possible solutions.

Stan Matthews, sales manager, processing division at MG America, spoke with Pharmaceutical Technology about trends and concerns in capsule production.

The University of Pennsylvania announces that it will collaborate with WuXi AppTech to research and develop gene vectors derived from recombinant viruses.