Pharmaceutical Technology Editors

Cell and gene therapy platform company, Locate Bio, has announced that it is set to receive key patents for its IntraStem technology covering the United States and Europe

Solentim and ATUM have announced a technology collaboration agreement that will focus on the creation of an efficient cell line development solution for biotherapeutic drug developers.

Lonza and Takeda have furthered their multiproduct partnership through collaborative efforts on a new cancer treatment-Alunbrig (brigatinib).

The Centre for Process Innovation (CPI) has led an Innovate UK project focused on the establishment of a generic framework and core capability to improve industrial productivity using computer models.

Almac Sciences has announced the expansion of its technology capabilities within its API services and chemical development portfolio through implementation of continuous flow expertise.

The companies will offer an IT platform that enhances the visibility and performance of the overall personalized medicine treatment process.

The agency revised draft guidance to enable more efficient and successful drug development programs for the treatment or prevention of rare diseases.

The Qualit-e Cloud web portal allows for secure uploading and sharing of quality documents for raw materials.

The United Kingdom’s government has emphatically voted against the Prime Minister’s proposed withdrawal deal in the largest defeat the House of Commons has faced in its history. So, what is next for Brexit and, in particular, the pharma industry?

The agreement gives Sanofi access to Biomunex’s proprietary bi- and multi-specific-antibody-generating platform.

The company will invest $4 million to increase topical and transdermal formulation development and performance testing services at its Durham, NC, facility.

Sanofi’s Adacel (tetanus toxoid, reduced diphtheria toxoid and acellular pertussis [Tdap] vaccine adsorbed) is approved for a repeat dose in people 10 through 64 years of age, 8 years or more after the first vaccination.

Pharmaceutical Technology spoke with CatSci Ltd about what their manufacturing process unique.

The company is set to expand biologics and fill/finish capacity at its biologics manufacturing sites in Madison, WI, and Bloomington, IN.

The revised guidance aims to strengthen the agency’s global approach to develop new antibacterial medicines.

The National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) revealed 22 new projects and funding aimed to advance US biopharmaceutical manufacturing.

A new gene therapy can turn certain brain glial cells into functioning neurons, which could help repair the brain after a stroke or during neurological disorders like Alzheimer’s or Parkinson’s diseases, according to researchers at Penn State.

Researchers at the University of Delaware have made a step forward in gene therapy by engineering microparticles that deliver gene-regulating material to hematopoietic stem and progenitor cells, which live deep in bone marrow and direct the formation of blood cells.

The plan details five goals to guide the development of Sentinel, a national electronic system for medical product safety surveillance established as part of the FDA Amendments Act of 2007, over the next five years.

The companies will collaborate to improve the manufacturability for two of Sanofi’s biotherapeutics.

Agenus will leverage Selexis’ SUREtechnology Platform to progress Agenus’ portfolio of next-generation antibody programs.

Boulting’s inspection software is a paperless, cloud-based system for maintenance of equipment in hazardous areas.

Fette Compacting America has introduced the FEC20 Capsule Filling Machine, capable of producing up to 200,000 capsules per hour, to the North American market.

Fujifilm increases capacity of its Bio-CDMO business with an expansion of production in North Carolina.

The $8-billion acquisition will broaden Lilly's oncology portfolio in precision medicines and treatments that target cancers caused by specific gene abnormalities.

Sun Pharmaceutical Industries, Inc. is recalling lots of Vecuronium Bromide for Injection because of glass particulates.

Tornado Spectral Systems, winner of the 2018 CPhI Excellence in Pharma Award for Analysis, Testing, and Quality Control, discusses real-time process measurement for biopharmaceutical and small-molecule drug manufacturing.

The company is recalling 5 lots of Ceftriaxone for Injection, USP, 250mg; 10 lots of Ceftriaxone for Injection, USP, 500mg; 24 lots of Ceftriaxone for Injection, USP, 1g; and 3 lots of Ceftriaxone for Injection, USP 2g because of the presence of particulate matter in reconstituted vials.

The companies entered a license agreement for the Trianni Mouse, a transgenic mouse R&D platform for the discovery of fully-human monoclonal antibodies (mAbs), to support MacroGenics’ discovery programs for mAb-based therapeutics.

A new plasma B cell antibody discovery workflow launched by Berkeley Lights enables the shortening of antibody drug discovery from month to a day.