Manufacturing

Attendees at the Bio-Process Systems Alliance annual summit discuss the benefits of single-use technology in biopharmaceutical manufacturing.

Cubist Pharmaceuticals voluntarily recalls certain lots of CUBICIN 500 mg in 10 mL single-use vials because of the presence of particulate matter.

Single-domain antibodies are emerging as credible alternatives due to their target specificity, high affinity, and cost-effective recombinant production.

Defining best biopharmaceutical practices is necessary to ensure the safety of the supply chain.

Unique Pharmaceuticals has issued a voluntary recall of sterile compounded preparations, but aired concerns about FDA?s recall demand.

PlantForm and PharmaPraxis announce plans to develop six biopharmaceutical targets for the Brazilian market.

Quantitative Mycoplasma DNA Offers Quality Control

Establishing the CQAs of a mAb product by evaluating impact and uncertainty during risk assessment.

Supplier Audit Program Marks Progress

With globalization, biopharmaceutical companies must establish strategies to minimize vulnerabilities in the raw-materials supply chain.

Challenges in Securing the Biopharma Supply Chain

New toxicology study demonstrates decreased mortality and better tolerability of ADC generated with Smartag platform versus conventional technology.

Aesica Pharmaceuticals S.r.I. collaborates with QAD to meet China's Food and Drug Administration's shortened serialization deadline.

FDA provides advice to supply-chain stakeholders on how to identify suspect drug products and how to notify the agency of those products.

Novartis facility becomes the first US site licensed by the FDA to produce cell-culture influenza vaccines.

The YSI Sitini Online Sampler draws fluids from a bioreactor and delivers the samples to an analyzer.

FDA issues a Form 483 to Wockhardt for quality issues at Morton Grove, IL facility.

Innovative polyethylene film sets new benchmark

PharmaCell has finalized its purchase of the cell therapy production facility from TiGenix.

The European Pharmacopoeia Commission re-evaluates its policy on the development of monographs for finished drug products.

Different approaches to prepare highly concentrated feed media for fed-batch Chinese hamster ovary cell culture are evaluated.

Suppliers see challenges to the adoption of single-use technologies for downstream processing as opportunities.

New formulations and expanded vaccine production are encouraged.

Progress is being made in the development of harmonized best practices for single-use systems.

New approaches to vaccine production are targeting rapid supply for pandemic situations and broadly effective therapeutic treatments.