Manufacturing

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.

PSE, a supplier of advanced process modeling software and services, plans to become part of Siemens Digital Industries.

The company will supply its heparin sodium injection in prefilled syringe form.

The new program, Cornerstone, integrates process development expertise and novel technology to remove development bottlenecks in the manufacture of gene therapy medicinal products.

The Industry 4. 0 tools of augmented and virtual reality aid pharmaceutical fill/finish equipment design, training, and troubleshooting.

The Phase III clinical studies for the drug candidate, elenbecestat, were discontinued based on a recommendation by a data safety monitoring board.

Starting on Oct. 1, 2019, CMC Pharmaceuticals will focus on upgrading laboratory SOPs and documentation practices to comply with FDA guidelines.

EMA plans to issue new guidance, as US and European regulators respond to reports of nitrosamine contamination in H2 blockers, including Zantac, that contain rantidine.

The venture will focus on single-use and modular systems designed to develop novel biotherapeutics.

Nephron Pharma and the University of South Carolina plan to build a sterile compounding lab at the University for research and training.

TrakCel and McKesson have formed a collaboration that is aimed at accelerating commercialization of cell and gene therapies by leveraging services to enable a more efficient development pathway.

FDA approved the drug after a successful open-label study of children aged six to 11 years and living with the condition.

The supply agreement comes after an eight-year collaboration between the companies.

The company’s Custom Single Run product line now has available bioreactors with working volumes of up to 6000 L.

Bayer will use ProBioGen’s GlymaxX technology to maximize the potency of its antibody drug candidate in development for oncological indications.

The new antibody, Citryll’s CIT-013, could offer new treatment options for various human diseases including lupus, vasculitis, pulmonary fibrosis, and organ damage due to sepsis.

Fette Compacting introduced its next-generation platform of tableting equipment with the F10i for small batches.