Manufacturing

An environmental study of single-use process technology for biopharmaceutical manufacturing offers a comprehensive examination of environmental impacts across the full process train using lifecycle assessment.

A novel approach to sterile drug product manufacturing that uses a single-use assembly in a multi-product final filling suite with isolator technology offers benefits of efficiency and flexibility.

FDA provides recommendations for submitting analytical procedures and methods validation data.

Thirteen companies are accepted for participation in the supply chain program.

Tandem Diabetes Care expands its voluntary recall of select lots of insulin cartridges used with t:slim insulin pump.

EMA releases an update on its flu vaccine guidance.

Studies show diminished cell growth properties associated with some biocontainer or bioreactor films.

With numerous biologics set to come off patent soon and the percentage of new therapeutics based on biomolecules growing, demand for contract manufacturing in the biopharma space is heating up.

A packaging defect has led to Merck voluntarily recalling all lots of Liptruzet tablets in the United States.

Key considerations for implementing single-use components or platforms when moving from research to process development.

Single-use systems and other technologies drive process efficiencies, but there is room for improvement.

Agency issues precautionary recall due to manufacturing fault.

Agency issues precautionary recall due to manufacturing fault.

Partnering with CDMOs can help bridge the innovation gap.

FDA details efforts to evaluate potential risks from use of nanomaterials in drug products and discuss analytical considerations, impact on stability, safety, and toxicology effects.

Alvotech plans investment in biosimilars portfolio and manufacturing facility.

TxCell has received manufacturing accreditation status of its cell-therapy production site in Besancon, France, from the French National Agency for Drug Safety (ANSM).

Drug Quality and Security Act gives FDA authority over compounding pharmacies.

A prototype Protein A resin is evaluated for purification performance, reusability, and cost performance.

New policies and products seek to maintain access to pain medicines while curbing rampant abuse.

Wolfgang Weikmann of Vetter Pharma discusses the implementation of quality by design in sterile manufacturing.

Criticality is used as a risk-based tool to drive control strategies.

The international “Fight the Fakes” campaign will raise awareness about the dangers of counterfeit medicines.

Almac releases an enhanced third-party logistics customer billing application.

GlaxoSmithKline plans to invest nearly $41 million to expand its operations at its facility in Montrose, the United Kingdom.