Manufacturing

Recent legislation and PDUFA initiatives aim to streamline oversight and testing requirements.

The unique structures of fusion proteins lead to expression, heterogeneity, and stability issues.

Continuous downstream bioprocessing is proving its worth, but connecting different operations and integrating upstream remains a challenge.

Improving the bioreactor growth environment increases the rigor of bioprocessing runs.

Lonza revealed it received a warning letter from FDA for its cell therapy manufacturing plant.

Cobra will increase capacity in response to customer demand for DNA and viral vector production.

The agency issued its recommendation for the influenza virus strains European vaccine manufacturers should include for 2017.

The company announced the expansion of its global shipping program, which now allows companies to ship dangerous goods between 36 countries.

GE Healthcare continues to ramp up its offerings in the bioprocessing space with the purchase of Asymptote and a continued partnership with Zenith Technologies.

In a new study, researchers from Boston Children’s Hospital study responses to pneumococcal vaccine in infant monkeys.

MilliporeSigma’s new high-area cartridge filters and single-use capsules are suitable for feed streams with high levels of particulates.

Chromatography modeling can enhance bioprocessing efficiencies.

The author discusses the impact of prefilled syringe product contact materials and the filling and stoppering process on protein aggregates.

OrlaSURF technology can be used for the development of target-binding assays to monitor the binding of an ADC to its antigen.

As regulators strive for balance in cGMPs for cell, gene, and tissue therapies, risk-management principles must guide decisions involving process media and additives.

Including next-gen antibodies in pharma pipelines is considered essential for future success.

Understanding the purpose of the biological indicator can guide the development of an effective sterilization process.

The mAb is the first approved treatment that targets the progressive form of the disease.

Tony Pidgeon, process technology director at Patheon discusses challenges associated with and recent innovations in the fill/finish process for biopharmaceuticals.

The facility in Britley will now manufacture the company’s automated systems, enabling the company to better serve European markets and shorten the supply chain.

The Mobius MyWay portfolio offers off-the-shelf and configured-to-order single-use assemblies.

The company has signed two separate agreements with the Agency for Science, Technology, and Research (A*STAR) and the Nanyang Technological University (NTU) to progress its therapeutic stem cell pipeline.

The Basel office will house the clinical development team and other functions to progress the company’s lead compound emapalumab.

In a FDAVoice blog post, CBER Director Peter Marks discusses the new designation for cell therapies that treat life-threatening diseases.

Richard D. Braatz, PhD, will discuss using mathematical models to design a continuous drug manufacturing plant and the differences between batch and continuous operations for biologics.