Manufacturing

Catalent’s licensing of Excelimmune’s antibody combination therapy platform can enable more consistent, cost effective production of antibody combinations.

Catalent licenses Excelimmune’s antibody combination therapy platform toenable the manufacture of multiple recombinant antibodies in a single batch culture.

The European Pharmacopoeia has incorporated new provisions to encourage the use of in-process quality control methods.

According to Sartorius Stedim Biotech, this acquisition expands its service offering for process development.

Biogen plans to build a biologics manufacturing plant in northwest Switzerland using next-generation technologies to create efficiency and sustainability.

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.