Development

Anna Kireieva/Shutterstock.comSpeed to market is essential in the biopharmaceutical industry today.

Despite GxP and data-management challenges, pharma is moving toward new models for clinical trial logistics.

Siliconization is a key process step in the manufacturing of prefilled syringe systems.

As part of the $900-million deal, Incyte will pay $150 million upfront to develop and commercialize an anti-PD-1 drug candidate from biopharmaceutical company, MacroGenics.

AbbVie will pay a $205-million upfront payment and have the option to develop and commercialize two antibody targets globally.

The company has opened new facilities and an innovation center in Singapore, China that will focus on the development of plant-based products.

The collaboration aims to improve the pharmacokinetics of anti-C3 proteases developed by Catalyst to develop therapeutics for severe eye disorders.

Inovio has reported results from a study with non-human primates that showed 100% effectiveness with a DNA vaccine the company is developing with the US Army.

The use of external retainers to enhance the seal between connectors and tubing is an essential component in single-use manufacturing systems.

The $72-million investment, part of a larger $850-million investment into its US operations, will allow the drugmaker to replace an outdated insulin vial-filling line and to upgrade technology at its Indianapolis manufacturing plant.

Through the support of the Japanese agency, Daiichi Sankyo intends to further develop its genetic vaccine platform focused around its new nucleic acid delivery technology.

The companies have entered into a strategic collaboration to establish a new cell therapy and regenerative medicine manufacturing platform, which includes a new manufacturing facility in Belgium.

NIH has entered a five-year, $215-million collaboration with leading biopharmaceutical companies to advance the development of cancer immunotherapies.

BARDA has entered a $12-million contract with biopharmaceutical firm Achaogen for the late-stage development of an antibiotic against resistant bacteria, and as a potential treatment for biowarfare agents.

Gelest, a manufacturer and provider of silane, silicone, and metal-organic compounds, released a range of dual-function poly(ethylene glycol) (PEG) reagents that enable new approaches to PEGylation for bioconjugates.

Virgin Atlantic Cargo and Delta Cargo have opened a new Pharma Zone at their joint facility at London Heathrow Airport for the handling and storage of pharmaceutical shipments.

There is a lot of interest in delivering biologics via non-invasive routes in attempt to improve patient compliance and convenience.

Nemera is now authorized to handle, assemble, sterilize, and store pharmaceutical drugs and medicinal products for autoinjector combination products at its facility in Neuenburg, Germany.

UPS has revealed a new system to improve drug supply chain security, in compliance with the Drug Supply Chain Security Act (DSCSA).

Ajinomoto Althea opens manufacturing suites in new high potency and antibody drug conjugate commercial facility.

The authors review methods for generating monoclonal antibodies for research and development.

Traditional planar culture formats are being superceded by microcarriers for large-scale cell therapy manufacturing.

A case study demonstrates that affinity chromatography can offer efficiency and scalability for gene therapy manufacturing using viral vectors.

Consider automation early in the rollout of clinical translation and scale up of clinical-trial protocols.

This review examines how microfluidics has been used in the formulation, preclinical, and clinical development of gene-delivery nanoparticles.

J&J’s Janssen ends a 2015 collaboration with Achillion Pharmaceuticals with a strategic decision to discontinue further development of a hepatitis C therapy in favor of pursuing hepatitis B therapeutics.

Genentech gets priority review for its application seeking a new indication for its anti-cancer drug, Gazyva (obinutuzumab), in treating follicular lymphoma.

The generic pharmaceuticals firm has sold its Baddi, India formulations manufacturing facility following a recent fire at its joint-venture plant in Algeria.

The US Patent and Trademark Office issued three new patents that extend protection for Alexion’s rare-disease drug, Soliris, for an additional 10 years.

The acquisition adds sterile manufacturing capability to the CDMO’s services, which include API formulation and manufacturing.