Manufacturing

ISPE’s survey is industry’s first large-scale effort to collect data on patient experiences with clinical trial materials.

Using closed systems opens up many new possibilities for how facilities are designed and operated and may also present lower risk to the operation and, ultimately, the product.

BioPharm International speaks with industry experts about challenges faced in managing the cold chain.

Legislators agree on a limited bill affirming FDA authority over compounders while setting up a process for national drug tracking.

USP is developing and revising distribution standards in response to changes in the global supply chain.

Data from BioPlan Associates' 10th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production suggest that the interest in disposable devices has begun to extend to biopharma operations beyond basic single-use bags and connectors.

The authors discuss the evolution of the purification platform for manufacturing of mAb therapeutics.

The authors discuss how to develop a cost-effective thermally protective packaging system.

Genzyme will build a facility in Massachusetts to expand purification capacity for Fabrazyme (agalsidase beta).

Roche plans multimillion biologic manufacturing expansions in California, Switzerland, and Germany.

PhRMA report reflects robust R&D in vaccine development.

The sterile injectable manufacturer Ben Venue decides to end production despite efforts to remediate cGMP violations.

Advanced Biosciences Laboratories will support the development and production of a novel Shigella vaccine candidate for PATH.

The first part of CPhI's Annual Expert Industry Report examines ADCs, single-use technology, and regulatory failure.

GlaxoSmithKline?s sale of its thrombosis brands is part of a focus on its late-stage pipeline.

Fujifilm Diosynth Biotechnologies? new mammalian cell-culture facility uses primarily single-use technologies.

Manufacturing standards are considered key to preventing drug recalls and shortages.

The authors review the angiopoietin pathway as an alternative for safer and more efficacious anti-angiogenic therapeutics.

The correlation between limulus amebocyte lysate (LAL) assay and rabbit pyrogen test (RPT) targeting recombinant human epidermal growth factor (rhEGF) as active molecule was assessed.

ATMI has invested in sterile-connector and sterile-fill technology developed by Medical Instill Technologies.

GE Healthcare Life Sciences announced that it will build a KUBio modular biopharmaceutical factory in China for JHL Biotech.

FDA Issues Draft Guidance on Patient Counseling Info for Labeling

Following passage in the California Assembly, the California State Senate passes legislation to specify requirements for dispensing biosimilars.

Mike Jenkins, general manager of Catalent Biologics discusses the evolving landscape of the biologics market and hurdles faced in the development and manufacture of these innovative products.

Restricted access barrier systems (RABS) maximize product control but minimize operator interaction in aseptic manufacturing.

Are strategic partnerships in clinical research a model for CMC services?

Novasep's Sius single-use tangential flow filtration skid offers a 100% single-use TFF solution.

New FDA supply chain policies aim to strengthen inspection and oversight processes.

As the complex requirements of manufacturing biologics are manifold, it is important that biomanufacturing companies adopt quality-by-design principles.

Continuous countercurrent tangential chromatography (CCTC) is a column-free process that provides a scalable, disposable, and cost-saving alternative to column chromatography.