Manufacturing

Experts discuss the advances in single-use technology for downstream bioprocessing applications.

Adopting single-use systems has implications for manufacturing execution systems (MES), process data-analytics tools, and scheduling. Enterprise resource planning and MES must be integrated using standards such as ISA-95. Master and electronic batch records must be designed to capture the details of single-use component assembly to enable traceability.

Researchers are using current understanding of the lyophilization process to predict performance on many levels during both process development and manufacturing.

ALpHA G Capsule Filter for Single-Use Systems

Manufacturers are taking measures to comply with new package safety rules.

For single-use systems, supply chain excellence requires a commitment to problem solving across organization boundaries.

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.