Manufacturing

Eric Langer, Managing partner at BioPlan Associates, speaks with Pharmaceutical Technology about biosimilar development trends.

Bill Hartzel, Director Strategic Execution, Advanced Delivery Technologies at Catalent Pharma Solutions, spoke with Pharmaceutical Technology about blow-fill-seal for aseptic processes.

Brady Cole, VP of Commercial Operations, at ABEC, spoke with Pharmaceutical Technology about biopharmaceutical manufacturing processes.

Gordon Haines, Chief Executive Officer, and Kay Thiele, Head of Product Optimization, at Rottendorf Pharmaceuticals, spoke with Pharmaceutical Technology about the human element in pharmaceutical manufacturing.

Barry Holtz, Principal, at Holtz Biopharma Consulting, and Klyo Collaborative, spoke with Pharmaceutical Technology about collaborative success strategies for biopharm companies.

The agency gives a limited reprieve to dispensers but requires other trading partners to provide product tracing information.

GSK will invest in an additional downstream isolation facility for amoxicillin production in Singapore.

The new column features Natrix’s signature macroporous hydrogel.

The 12th Annual Report and Survey of Biomanufacturing is now available.

More biopharma companies choose outside service providers for assay testing.

Novasep's new antibody drug conjugate facility at its site in Le Mans, France will be commissioned in 2016.

Pharmacy associates say more education regarding the transactional requirements of DSCSA is needed.

ACG Worldwide discusses current and future uses of capsules in a video interview with Pharmaceutical Technology.

L.B. Bohle discussed tablet coating in a video interview with Pharmaceutical Technology.

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.

Monoclonal antibodies can facilitate the entry of radiopharmaceuticals into cells, David Scheinberg said at BIO 2015.

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

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

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

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

Presenters at IVT's Microbiology Week discussed best practices and recent guidance publications for microbial control in sterile and non-sterile pharmaceutical processes.

Although full traceability is not required by law in the US until 2023, companies could benefit from implementing it now.

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

Nic Michel, General Manager of Pharma Technology, Inc., spoke with Pharmaceutical Technology about the application of external lubrication in tablet production.

Catalent’s Singapore facility is awarded GMP certification.

Vetter completes on-site expansion activities of visual inspection and in-process control at Chicago facility.

West Pharmaceutical began construction on its component manufacturing facility located in Waterford, Ireland.