Manufacturing

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.

Automated, electronic systems for raw materials tracking improve efficiency and prevent mistakes in biopharma manufacturing.

Software systems can help validate pharmaceutical manufacturing and steer the most appropriate design of processes in the right direction.

PPD is expanding its bioanalytical lab in Richmond, VA, to enhance its immunochemistry, biomarker, and chromatography services.

Cellink’s BIO X6, a six-printhead bioprinting platform, offers the capability to combine more materials, cells, and tools to enhance research applications across the bioprinting field.

The new device decreases the chances of filter leaks and room contamination while ensuring the lowest possible energy consumption.

The new line can fill, band, and check the weight of 80,000 to 120,000 capsules per hour.

The inspections took place at the company’s Charnwood, UK, Craigavon, Northern Ireland, and Audubon, PA, locations.

GSK’s expanded R&D and manufacturing facility in Upper Merion, PA houses a new analytical lab and flexible manufacturing equipment, including single-use bioreactors.

The new site will provide employees with more space, enhanced R&D facilities, and a fully functional sanitary products training center.

Pii is now responsible for commercial drug product production of fulvestrant, a breast cancer drug, while Sagent Pharmaceuticals, its abbreviated new drug application holder, will sell, market, and distribute the drug product in the United States.

The companies will focus on identifying peptides applicable to the affinity chromatography process used in the purification of biopharmaceuticals.

A request has been made to the CHMP by the executive director of EMA to provide guidance on how to avoid the presence of nitrosamine impurities in human medicines.