Manufacturing

Ronald A. Rader is senior director, Technical Research, at BioPlan Associates.

Eric Langer has over 25 years experience in biotechnology and life sciences strategic marketing management, market research, and publishing. He has held senior management and marketing positions at biopharmaceutical supply companies. He has published and authored many books and reports on topics in Biotechnology, Large-scale BioManufacturing, and bioscience commercialization and communication. He teaches at Johns Hopkins University marketing management, biotech marketing, services marketing, and marketing in a regulated environment. In 1989 he co-founded BioPlan Associates, Inc. to provide market analysis, and strategy to biotech and healthcare organizations.

Articles

This article highlights 15 years of changes in biopharmaceutical manufacturing.

Fifteen Years of Progress: Biopharmaceutical Industry Survey Results

Ronak Savla is scientific affairs manager at Catalent Pharma Solutions.

Claus-Michael Lehr is head of the drug delivery department at the Helmholtz-Institute for Pharmaceutical Research Saarland, SaarbrÃ¼cken, Germany.

Brigitta Loretz is a scientist at Helmholtz-Institute for Pharmaceutical Research Saarland, SaarbrÃ¼cken, Germany.

Olga Hartwig is a PhD student at the Helmholtz-Institute for Pharmaceutical Research Saarland (HIPS), SaarbrÃ¼cken, Germany.

William Wei Lim Chin is a technical specialist, science and technology, at Catalent Pharma Solutions.

Macromolecular drugs are typically injected, but oral dosage forms are being developed to improve the treatment of gastrointestinal conditions such as inflammatory bowel disease.

Oral Delivery of Macromolecular Drugs

This marks the third FDA approval for the company’s second biomanufacturing plant in Incheon, Korea.

Samsung BioLogics Receives FDA Approval for Biologic Drug Substance Manufacturing

The European Commission has approved Zessly (infliximab), a biosimilar to Johnson & Johnson’s blockbuster Remicade (infliximab).

Novartis Gains EC Approval for Infliximab Biosimilar

Valerius Biopharma will use Catalent’s GPEx technology to produce cell lines for biosimilar drugs.

Catalent to Develop Biosimilars for Valerius Biopharma

Celltrion received complete response letters from FDA for its rituximab and trastuzumab biosimilars.

FDA Issues CRLs to Celltrion for Two Biosimilars

The companies have created Syna Therapeutics, a joint venture that will develop biosimilars and new molecules.

Reig Jofre and Leanbio Form Joint Venture to Develop Biosimilars

Sartorius Stedim Biotech has launched a new automated parallel bioreactor system for
perfusion culture. 

Ambr 250 High Throughput Bioreactor System Speeds Up Intensified Cell Culture Process Development

The funding from the Walloon Region will enable Univercells to start developing a manufacturing platform aimed at driving down costs of biosimilars manufacturing.

Univercells to Develop Antibody Production Platform with $2.9-Million Grant

The contract manufacturing company has completed construction on a new aseptic fill/finish facility in Wuxi, China.

Manufacturing, Biosimilars and Biobetters