Manufacturing

The authors examine the selection process of the contract manufacturing–pharmaceutical relationship and the communication challenges that pharmaceutical firms face prior to and during the CMO selection process.

Andrea Zobel, senior director of product management, clinical trial supply, and logistics at PAREXEL International, examines key issues and questions that sponsors and contract partners must address.

Good project management, budgeting, planning, and clear documentation are the only ways to prevent overruns and project failure.

BioPharm International speaks with a CMO to find out how it is coping with capacity challenges, regulatory authority scrutiny, supply chain reliability, and new requests from clients to incorporate continuous manufacturing into processing lines.

FDA sent a warning letter to Pharmaceutic Labs, LLC for deficiencies in producing sterile drugs.

Operated by BioOutsource, Sartorius’ subsidiary, the Glasgow, UK-based service center will offer physicochemical properties and structural attributes testing and allow clients to perform structural and functional analyses in parallel.

Can bioprocessing runs be consistently replicated in an inherently variable production environment?

Robotic fill/finish systems reduce human intervention, improve flexibility, and allow more gentle handling of containers.

Avid, a wholly owned subsidiary of Peregrine Pharmaceuticals, will upgrade its Myford, California clinical and commercial manufacturing facility with multiple Mobius 2000-L single-use bioreactors from MilliporeSigma, the companies announced on May 1, 2017.

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.