Manufacturing

Two experts discuss best practices to achieve acceptable sterility assurance levels for aseptically filled products.

The global supply chain for bovine and porcine heparin and regulatory considerations are examined.

Virtual pilot programs examine scenarios that may occur while implementing serialization requirements for the US Drug Supply Chain Security Act.

The authors present a review of the techniques commonly used for glycosylation analysis.

The “next-generation” design for the pods will build on Pfizer’s existing modular prototype for oral solid-dose manufacturing.

The novel antibody-engineering platform works differently than most of the currently employed antibody-modifying technologies, according to UM Baltimore.

ProBioGen plans to develop and scale-up production of a biosimilar to the mAb cancer drug trastuzumab and will transfer the commercial manufacturing process to Indonesia’s government-owned Bio Farma.

Univercells will integrate its single-use bioprocess with the Takeda vaccines production platform to allow local production.

The agency provides terms and recommendations for packaging and labeling of injectable medical products.

Biovest’s mAbVault provides supply-chain redundancy for antibodies that enables customers to lock in price-per-gram protein production.

Regeneron announced additional investments to its Limerick, Ireland biologics production facility.

The agency gives an update on the regulation of combination medical products.

Scottish injectable-drug manufacturer Symbiosis Pharmaceutical Services plans to expand its sterile filling facility.

Avantor released a packaging platform that allows for the direct dispensing of chemicals-such as salts, buffers, and cell culture ingredients-into processing equipment.

Hiroaki Suzuki will lead Vetter’s business activities in the new Tokyo-based office.

Althea is expanding its existing biological drug product manufacturing operations to include highly active materials, such as antibody-drug conjugates, in a new facility near San Diego, CA.

The company presented a portfolio of new products during the meeting in Madrid.

Product labels should include more information on extrapolation, interchangeability, and the original source of clinical trial data, according to a survey of those in charge of dispensing medications.

Cell Therapy Catapult will provide manufacturing scale-up services to enable Asterias’ future clinical trials and commercial supply for Asterias’ allogeneic dendritic cell immunotherapy, AST-VAC2.

The Bothell, WA location will help the company reach its goal of expanding its global capacity by more than 30,000 liters.

The challenge of achieving zero visible defects (i.e., particulates) in parenteral drugs will require a coordinated effort at all stages of the supply chain, particularly in the production and filling of primary containers.

The Cell History File is designed as a “cell passport” for developers and manufacturers of tissue- and cell-based medicinal products.

Probiodrug has signed an agreement with Rentschler Biotechnologie GmbH for the development of PBD-C06, a pGlu-Abeta-specific monoclonal antibody, as treatment for patients with Alzheimer’s disease.

The agency provides recommendations for submitting proposed labeling with abbreviated new drug applications.

BioPharm International eBooksVolume 28, Issue 14 Single-use technologies including polymer film bags, tubing, filter capsules, and appropriate connectors have become widely accepted in bioprocessing of proteins and vaccines.

Isolators offer a safety and economic advantage for next-generation regenerative medicine products.

Rafe Swan/Getty Images; Dan WardIrreproducible preclinical research is a global, expensive, and well-recognized problem that contributes to delays a

The authors present the results of a survey of biologics manufacturers to evaluate how these manufacturers transfer analytical methods.

The author explores a dual-supplier sourcing strategy for single-use products and its ability to mitigate business continuity risk.