BioPharm International Editors

GSK accelerates delivery timeline for US quadrivalent flu vaccine.

Industry experts from Biocon, PBOA, PCI, and Pharmatech Associates join CPhI annual report for 2015.

AAPS Foundation announces 2015 new investigator grant and graduate student fellowship winners.

Evans Analytical Group expands into the pharmaceutical/biopharmaceutical industry with acquisition of ABC Laboratories.

Mylan issued a voluntary withdrawal of calcium chloride intravenous infusion 10% w/v 10mL prefilled syringe due to difficulties in administration.

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.

Consisting of a needle hub and a needle shield, the new syringe closure system is partly produced by means of a two-component injection molding process of polypropylene and thermoplastic elastomer.

Two companies have been fined a total of GBP550,000 for faulty insulin syringes, which contained no drug and caused the death of a diabetic patient.

The collaboration will address the need for novel analytical approaches for the characterization of glycans.

FDA released news of the ban of Emcure’s Hinjewadi manufacturing plant after it determined the plant did not meet basic quality standards.

The new sizes follow the 2014 launch of the company’s fully disposable purifier.

This collaboration is said to be the first established between the Crick and a pharmaceutical company.

The agency requires early notification of potential drug shortages.

The European Medicines Agency reviews the safety of human papillomavirus vaccines.

The International Conference on Harmonization has moved ICH M7(R1) Addendum to 3 of the ICH process.

The new project will increase fill/finish manufacturing capacity for select products on FDA’s Drug Shortage Index.

Charles Rivers strengthens its endotoxin testing and bacterial identification detection capabilities with the addition of Celsis’ products.

A large health system will use the biosimilar version of infliximab from Hospira after the company offered a discount of 45%.

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.

The addition of a new manufacturing line at Lonza’s Portsmouth, NH site enables Alexion to add dedicated product supply for 10 years.

The new facility expands the company’s commercial manufacturing capability at its Bend, Ore. site.

The agency gives a limited reprieve to dispensers but requires other trading partners to provide product tracing information.

GSK will invest in an additional downstream isolation facility for amoxicillin production in Singapore.

Australian company, Genea Biocells, will open a facility in San Diego, California for cell and culture-media manufacturing and R&D.

The new column features Natrix’s signature macroporous hydrogel.

The US Pharmacopeial Convention hosts compliance seminar at CPhI China 2015.