Manufacturing, Biologic Drugs

BMS changes its US geographic footprint with R&D investments and closures.

Biosimilars may be the key to CMO growth.

Takeda will invest more than 100 million Euros to build a new manufacturing plant for its dengue vaccine candidate in Singen, Germany.

Avecia is adding drug substance capacity at its Milford, MA manufacturing site.

German biotech ARTES and Iranian biopharma manufacturer BioSun will develop an HPV vaccine.

Astellas will acquire Ganymed and its portfolio of ideal monoclonal antibody candidates.

The Koolit Advanced PCM Gel from Cold Chain Technologies provides cold-temperature protection for drugs and vaccines during transport.

Regulators are tightening up on post-marketing monitoring of biological medicines to detect deficiencies caused by manufacturing problems, particularly those stemming from post-authorization changes in the manufacturing process.

Ravi Limaye gives an overview of the biosimilar industry and projects for 2020.

Aptar Pharma has signed a license agreement with BD to jointly develop and bring a new autoinjector to market.

The agency has adopted guidelines on the pharmacovigilance of biological drugs.

The Phase I trial will test Bavarian Nordic’s vaccine, which is manufactured using a vaccine vector based on smallpox.The recent resurgence of yellow fever incidences over the past six months has prompted health officials to ramp up the fight against the virus. Like the Zika virus, yellow fever is transmitted primarily through the bite of infected female Aedes aegypti mosquitoes.

The vaccine candidate has also won a Priority Medicines (PRIME) status from EMA.

The company will invest €100 million in the expansion of its Athlone facility.

A study shows high levels of ADAs to infliximab at the beginning of treatment were associated with a poor response later on.

Integrating quality and compliance with technology transfer and careful project management are key in starting up a facility and launching a biologic drug.

Aseptic spray drying provides an alternative to lyophilization as an enabling stabilization technology for parenteral biologic formulations.

MilliporeSigma and the International Vaccine Institute in Seoul, South Korea aim to develop more robust, scalable vaccine manufacturing processes.

Studying broadly neutralizing antibodies in infants may lead to new pathways in HIV vaccine development.

The inactivated vaccine, manufactured with a GE FlexFactory system, could be associated with fewer adverse reactions than the live vaccine option.

The wearable devices for the delivery of biologic products are now being manufactured and will be tested in clinical trials in the near future, according to the company.

Experts discuss the key considerations in the development of an autoinjector.

Collaboration and single-use technologies aided the rapid scale-up of Ebola vaccine manufacturing

MilliporeSigma expands its Carlsbad, California-based GMP capacity for viral and gene-therapy products by nearly 90%.

Sanofi will invest in its Geel, Belgium facility in order to support its pipeline of monoclonal antibodies.

A report by Reuters found that four of the top 10 most widely used drugs increased 100% since 2011, while the other six increased 60%.

Global outbreaks energize vaccine R&D and drive production modernization.

Novo Nordisk broke ground on a facility in Clayton, NC, to manufacture APIs for GLP-1 and insulin medicines.

Asking the right questions is crucial to establishing a biopharmaceutical facility design.

Takeda Pharmaceuticals announced the acquisition of a biopharmaceuticals manufacturing plant in Minnesota.