Manufacturing

The author discusses the current best practices in technical qualification of single-use systems.

New single-use technologies and other filtration systems are beginning to address cost, throughput, and manufacturing footprint demands.

The Pre-Connect Congress will explore pharma industry trends, such as mergers and acquisitions, the biologics market outlook, and innovation in drug delivery among others.

The TRUST project will focus on the process development of Col-Treg, which is TxCell’s autologous collagen type II specific Treg immunotherapy product for the treatment of autoimmune uveitis.

Shire requests a technical transfer from Sanquin to widen its manufacturer base for the production of Cinryze.

Biopharmaceutical company BeiGene plans to build facility in Suzhou to expand its clinical capability and prepare for commercial manufacturing.

Licenses could potentially bring antibody R&D to areas beyond oncology, such as diabetes treatments

WuXi said its biologics manufacturing business will be one of the company’s key growth drivers over the next several years.

  Juno Therapeutics shared some of its business strategies related to process development and manufacturing in a second-quarter earnings call on Aug. 12, 2015. According to CEO Hans Bishop, the company believes its progress in the manufacture of chimeric antigen receptor (CAR or CAR-T) T-cell products will drive the company’s success for all of its product candidates and will be especially important for JCAR015, its investigational treatment for acute lymphoblastic leukemia (ALL). FDA cleared the investigational new drug application for JCAR015 on July 30, 2015.

The partnership will help divert 840 tons of waste related to single-use products from landfills or incineration during the next year alone.

CMC Biologics will manufacture monoclonal antibodies (mAbs) and provide process development services for the PATH Malaria Vaccine Initiative.

The company closed its Zebulon-based plant after routine testing of a cooling tower revealed the presence of the bacterium responsible for Legionnaire’s disease.

GEA's self-contained homogenizer is designed for laboratory applications, including cell dispersions.

Deal includes rights to Inovio’s INO-3112 HPV cancer vaccine and preclinical collaboration to develop additional cancer vaccine candidates.

Flexion will have a dedicated manufacturing suite at Patheon's Swindon, England facility for Flexion's osteoarthritis injectable steroid drug product.

The new, still unnamed biosciences arm of Emergent BioSolutions will be a separate public company with a focus on novel therapeutics in immuno-oncology.

US generics manufacturer Amneal acquires a former J&J plant in Ireland.

The agreement gives Merck a non-exclusive license to use Codexis’ proprietary CodeEvolver protein engineering platform technology to develop novel enzymes for use in the manufacture of Merck’s pharmaceutical products.

FDA issues draft guidance on dissolution testing for immediate-release solid oral dosage forms.

Industry experts spoke to BioPharm International about the key considerations in the development of a drug-delivery device for a biologic drug, the importance of human factors engineering, the advantages of prefilled syringes, and the challenges in the manufacture of these devices.

Process maps and risk assessments are among the valuable tools operators can apply to reduce the risk of microbial contamination.

A thorough cell-bank testing plan is necessary to certify the safety and purity of a resulting biopharmaceutical product.

The authors explore the use of statistical experimental design and multivariate analysis to develop a drug substance formulation matrix.

Gene and cell therapies represent the next-generation treatments for a wide range of diseases, but one challenge in the development of these therapeutics is the controlled delivery to the targeted site to maximize expression or engraftment while limiting systemic exposure.

FDA and industry support global framework and collaborations to secure the supply chain.

This article discusses cleaning validation of equipment dedicated to the production of a single API.

Industry experts discuss challenges, trends, and innovations in fluid handling.

The new service offering includes feasibility studies, process and analytical development, and scale-up from milligram to gram quantities required for pilot and subsequent commercial scale.

CMC Biologics and River Vision Development announce manufacturing agreement for RV001, a monoclonal antibody to treat Grave’s orbitopathy.