Manufacturing

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.

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.

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.

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.

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.

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

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.

The drug displayed improvement in progression-free survival and increased the time patients lived without disease progression or death by a median of 18.9 months.

The new facility, located in Ness Ziona, Israel, will support clinical phage manufacturing and can be expanded in the future to support commercial-scale manufacturing.