Manufacturing

BioPharm International spoke with Selexis CEO and Chairman Igor Fisch, PhD about the latest cell-line development advances.

Designing systems using the principles of good documentation practice, including validated audit trails, is a key piece of a manufacturing data integrity program.

A technology management process identifies and evaluates new technologies in biopharmaceutical manufacturing to aid business decisions.

Plant transient expression offers a flexible approach in drug development and enables rapid production and scale up of therapeutics.

Experts discuss recent advances in cell viability testing methods in bioreactors.

The companies will collaborate the manufacture of personalized cancer vaccines.

HHS entered into a contract with BioProtection Systems Corp. for commercial manufacturing tests of an Ebola vaccine.

WuXi AppTec’s new biomanufacturing facility is its third facility in the Philadelphia, PA Navy Yard.

Results from the Phase III POLLUX trial with Janssen’s Darzalex showed that the drug was effective at reducing disease progression in patients with relapsed or refractory multiple myeloma.

The companies are collaborating on the commercialization of two biosimilar candidates in the US and Canada.

A report from the European Union Intellectual Property Office shows that the EU loses approximately €10.2 billion a year due to counterfeit medicines.

The time and resources required to finalize post-approval changes may be preventing manufacturers from modernizing facilities, or even scouting for new technology.

The company announced that it will build a new manufacturing facility at the GMR Aerospace Park at the Rajiv Gandhi International Airport in India.

Constantia Flexibles acquired a flexible packaging business from Lamp San Prospero SPA.

Xellia added laboratory space and personnel in Zagreb, Croatia to work on anti-infective products that combat the antimicrobial resistance problem.

A PESU membrane is now available for Sartorius Stedim Biotech Sartocon benchtop and production-scale filtration assemblies.

Allergan entered into a licensing agreement with AstraZeneca for MEDI2070, an anti-IL-23 monoclonal antibody in phase IIB development for the treatment of patients with moderate-to-severe Crohn’s disease.

The hospital received a five-year $5 million grant from CDC to survey for communicable diseases in children and evaluate vaccine effectiveness.

ViraTherapeutics will develop its VSV-GP therapy alone and in combination with other therapies.

PaizaBio will add aseptic injectable production capacity in Hangzhou, China.

Susan Schniepp, distinguished fellow at Regulatory Compliance Associates, discusses the assessment of risk in the processing of intravenous injectable drugs.

Laser-induced fluorescence, a rapid microbiology method for real-time airborne particle and microbial monitoring, enhances sterility assurance in pharmaceutical manufacturing.

As the pressure to bring drugs to market more quickly increases, companies are faced with the challenge of selecting the most effective cold-chain storage solutions.

High-purity low-endotoxin sugars improve robustness and stability of protein formulation and improve drug product quality.

Multiparticulates are increasingly used due to their flexibility in providing controlled-release, fixed-dose combinations, ease of taste-masking, and suitability for pediatric applications