Manufacturing

Ready-to-use components help compounders and manufacturers of small batches overcome economy-of-scale limitations in aseptic GMP manufacturing.

Over a two-year period, FDA inspections at company facilities found repeat problems with quality systems including lack of written procedures, inadequate investigation of out-of-specification conditions and corrective and preventive action, and insufficient cleaning and cleaning validation.

Emphasizing the need for senior management to take cGMP compliance seriously, the agency pointed to “improvisational” validation procedures, lack of compliance with written procedures, as well as inadequate process control, root cause analysis, and corrective and preventive action (CAPA) in its warning letter.

Optima Packaging explains its approach to process design.

Systems-based pharmaceutics case studies, challenges, and new uses were discussed at PSE’s Advanced Process Modeling Forum.

Automated fill/finish and inspection equipment displayed at the 2019 Healthcare Packaging Expo improves quality and efficiency.

The new location is one of the world’s first digital facilities to use intensified, continuous biologics production technology.

Lonza, through its Ibex Solutions, will now cover preclinical and clinical development and manufacturing for a significant portion of Genmab’s pipeline.

On Wednesday Nov. 6, 2019, Gregor Deutschle and Dr. Nicolas Eon, both from Schott, will share insights into ready-to-use solutions for complex biotech drugs.

CPI, the University of Strathclyde, GSK, and AstraZeneca Collaborate on a continuous direct compression digital twin for pharmaceutical formulation optimization.

MilliporeSigma will now be the first company to make acoustic technology available for cell therapy manufacturing.

The new facility raises production capacity by an additional 19,100 m2 and creates 200 new full-time jobs.

The increased capacity will enable the company to guarantee short production timelines.

GSK invested $139 million to its Rockville, MD site to support demand for Benlysta.

The agency has approved Gilead Sciences’ Descovy (emtricitabine 200 mg and tenofovir alafenamide 25 mg) for reducing the risk of HIV-1 infection.

The contraceptive is expected to receive new chemical entity designation from FDA, giving it patent protection beyond 2030. It will be launched in early 2021, pending FDA approval.

Manufacturing of the cell line will take place at Lonza’s GMP facility in Geleen, Netherlands.

The companies agreed to a multi-year research and development collaboration that will focus on AI empowerment and exploration.

Data showed that the drug candidate activated T regulatory cells, believed to serve a crucial role in protecting the body from uncontrolled inflammation or autoimmunity.

The new incubators are set to be operational starting in 2021.

Researchers used advanced animal model lab tests to determine the new vector is 10 times more efficient at incorporating corrective genes into bone marrow stem cells than traditional vectors.

MG America’s Extrudor system for its capsule filling equipment uses only one dosing disk per capsule size for all dosages.

Changing regulatory guidance on generic topical products is expected to lead to an increase in the number of market approvals in the near future.

Establishing OEL data and ensuring appropriate engineering controls are crucial aspects of safe handling.

Advances in fill/finish for parenteral packaging address demands for efficiency and product safety.