Manufacturing

The Mobius 2000-L single-use bioreactor from EMD Millipore offers configurable software, hardware, and single-use Flexware assemblies for suspension and adherent cell-culture applications.

FDA released news of the ban of Emcure’s Hinjewadi manufacturing plant after it determined the plant did not meet basic quality standards.

The agency requires early notification of potential drug shortages.

The European Medicines Agency reviews the safety of human papillomavirus vaccines.

The new project will increase fill/finish manufacturing capacity for select products on FDA’s Drug Shortage Index.

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.