Manufacturing

The addition of a new manufacturing line at Lonza’s Portsmouth, NH site enables Alexion to add dedicated product supply for 10 years.

The challenges and strategies of assessing and mitigating risk in biopharmaceutical manufacturing are discussed.

The use of single-use systems in downstream processing offers benefits in filtration and sampling and may reduce the risk of contamination.

The European Union has a challenging task ahead as it strives to harmonize regulations on advanced therapy medicinal products.

The new facility expands the company’s commercial manufacturing capability at its Bend, Ore. site.

Sartorius Stedim Biotech’s Sartoclear Dynamics is a clarification system designed to harvest mammalian cell cultures with high cell densities using single-use technology.

Richard Johnson, President and CEO of the Parenteral Drug Association (PDA) speaks with Biopharm International.

Eric Langer, Managing partner at BioPlan Associates, speaks with BioPharm International about the results from the 12th annual BioPlan Associates survey, and single use technology adoption.

Eric Langer, Managing partner at BioPlan Associates, speaks with BioPharm International about biosimilar development trends.

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

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

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

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

Dennis Brandl, President, at BR&L Consulting, spoke with BioPharm International about what should be expected when transitioning from paper to EBR.

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.

Australian company, Genea Biocells, will open a facility in San Diego, California for cell and culture-media manufacturing and R&D.

The divestment of Nimenrix and Mencevax was to satisfy regulatory clearances when GSK gained Novartis’ vaccines business in an asset swap in March 2015.

IDT Biologika acquired Aeras' vaccine manufacturing facility, and the companies will work together on tuberculosis vaccine development.

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.

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).

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

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.

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

BioSC Lab biochromatography system performs protein purification in batch and continuous modes.