Pharmaceutical Technology Editors

The companies announced a commercial supply agreement following FDA’s accelerated approval.

Biopharma company, Zelluna Immunotherapy, and clinical stage biotech, Glycostem Therapeutics, have entered into a partnership focused on the development and manufacture of allogeneic T-cell receptor guided Natural Killer cell therapies for the treatment of cancer.

Label management specialist, Prisym ID, announced that its clinical trial solution, PRISYM 360, has been chosen by CME to be part of a just in time clinical trials handling system for the Medicines Manufacturing Innovation Centre project.

The company announced it was named the winner of the Analysis, Testing, and Quality Control category.

The new site will be used for the storage of contingency stocks of European Pharmacopoeia reference standards for distribution worldwide in case of major incidents at its main site in Strasbourg, France.

The new API for hypothyroidism treatment will replace the hormones that are ineffectively produced by the human thyroid gland.

New training facilities, laboratories, packaging, gene therapy manufacturing, and biologics manufacturing highlight Thermo Fisher Scientific expansions.

Lubrizol Life Science Health adopts new name and opens commercial manufacturing facility.

BASF launches digital solutions for the pharma industry during CPhI Worldwide 2019.

Fujifilm Diosynth Biotechnologies will add a new building, including gene therapy laboratories, to its facility in College Station, TX.

Schott and W.L. Gore introduced a prefillable, silicone-free glass syringe system, which won an award at CPhI Worldwide.

West introduced NovaPure 3-mL Cartridge components and the SmartDose Gen. II 10-mL injector.

The company showcased its compact robotic nest filling machine at CPhI Worldwide 2019 on Nov.–7 in Frankfurt, Germany.

The agreement paves the way for GSK’s specialty HIV company, ViiV Healthcare, to develop a broadly neutralizing antibody, N6LS, for HIV treatment and prevention.

The companies have entered into a clinical and commercial agreement to use MaxCyte’s ExPERT platform to enable development of up to five of Vor’s engineered cell therapies.

Bora announced the appointment of Samuel Ricchezza as president of its North American operations.

Rentshler Biopharma has begun its expansion project in the United States by putting a single-use bioreactor into operation at the Milford facility in Massachusetts.

Lonza and Cryoport have partnered up to strengthen Lonza’s ‘vein-to-vein’ delivery network by removing supply chain hurdles faced by developers of personalized therapeutics.

During CPhI Worldwide in Frankfurt, Germany, Datwyler launched its Starter Pack, which features its Omni Flex stoppers and Prime Caps along with Schott’s adaptiQ vials, targeted at clients looking to tackle small quantity component needs.

Luxembourg-based company, C2 Pharma (C2P), has expanded its API and botanical extracts product portfolio with digoxin micronized grade and homatropine hydrobromide, and has multiple products under tech transfer and in development.

Beckman Coulter Life Sciences and IncellDx have announced a collaboration aimed at creating awareness for the oncology assays on the cytometry platform for European customers.

GE Healthcare Life Sciences has announced it will be working closely with Pharmadule Morimatsu to expand its KUBio “factory in a box” so that biopharma manufacturers will be able to quickly scale up vaccines, viral vector-based therapies, and other novel modalities.

Sangamo Therapeutics has revealed that the United Kingdom’s Medicines Healthcare Products Regulatory Agency (MHRA) has authorized the first in-human clinical trial evaluating a chimeric antigen receptor regulatory T cell (CAR-Treg) therapy.

According to the first annual resport into clinical trials by the Association of the British Pharmaceutical Industry, the United Kingdom is leading the rest of Europe in early-stage clinical research into new medicines and vaccines.

The agency sent a warning letter to Torrent Pharma after an inspection found violations of current good manufacturing practices that included a failure to thoroughly investigate batch failures.

Countries and partners have announced commitments to vaccinate 450 million children against polio each year and overcome barriers to reaching all children.

Xcelerate Development Services are complete solution services focused on de-risking development and ensuring speed-to-market.

The company introduced its new advanced elastomer, the 4040/40 formulation, and a new line extension of its AccelTRA component program, AccelTRA Select, at CPhI Worldwide from Nov. 5–7 in Frankfurt, Germany.

Through a partnership with the Sobti family, the CDMO will expand is injectable dosage form capabilities.

The new service will assist pharmaceutical companies with quality control and analytical requirements.