Manufacturing

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.

Cytovance Biologics Inc. announces development and manufacturing deal with NeuroFx for stem-cell-derived cell-free therapy for strokes.

Financial expectations for Baxter’s biopharma solutions arm will drop 10% as the result of a client’s decision to move its manufacturing in house.

A broad indication for GSK’s investigational mAb mepolizumab, coupled with an upcoming FDA decision date, could give the manufacturer a competitive advantage in the biologic asthma market.

The contract is a memorandum of understanding for the manufacturing by MaSTherCell of clinical batches of TxCell’s Ovasave.

Will AbbVie stave off biosimilar competitors by following Teva’s model for Copaxone?

Manufacturers are producing new drugs and vaccines and clinical supplies faster and more efficiently through the development of standards and common practices for single-use technology systems.

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has announced a positive scientific opinion for GlaxoSmithKline’s (GSK’s) malaria candidate vaccine Mosquirix (RTS,S) for use outside of the European Union (EU) in children aged 6 weeks to 17 months.

World Courier receives pharmaceutical storage and transportation accreditation in the United Kingdom.

The $19.7 million contract will assist Emergent with the development of cGMP lots of three Ebola mAbs.

CSafe and AES will support controlled-temperature shipping through the Basel, Switzerland airport from their new service center.

Biogen will take ownership of Eisai's Research Triangle Park manufacturing campus and will manufacture both oral solid-dose and parenteral drugs for Eisai.

Baxter has initiated a voluntary recall of two lots of IV solutions due to the potential presence of particulate matter.

GSK accelerates delivery timeline for US quadrivalent flu vaccine.

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.