News

Purna Thakker, founder and CEO of ADPT Solution, discusses common issues that companies face with FDA regulations at CPHI North America.

The company’s presentation at ASGCT includes preliminary data results for a child who received the gene therapy.

Experiments conducted by the downstream technology team at Spark Therapeutics involving metal ion-containing additives showed improved capsid clearance in AAV production.

The company is presenting preclinical data at the American Society of Gene & Cell Therapy annual meeting that supports the potential of the company’s CAP-002 gene therapy for correcting neurological phenotypes associated with genetic epilepsy due to syntaxin-binding protein 1 (STXBP1) mutations.

Novel delivery technologies enhance brain penetration to target neurodegenerative diseases and glioblastomas.

ProPharm and PBL have introduced a fully automated, enclosed cell factory manufacturing device.

The two companies will combine their cell therapy platforms to develop convertibleCAR programs targeting solid tumors.

The request for more information was received weeks after an application to the FTC was refiled to approve the deal.

A new draft guidance issued by FDA covers human- and animal-derived materials used in the manufacture of advanced therapy medicinal products.

Cormica’s first US Acquisition is intended to support to organic growth of TPM laboratories.

Pharmaceutical company, Nanomerics, and several companies that work with the pharmaceutical industry have been recognized by King Charles III for business achievements.

The loan is intended to support Ennogen’s growth as it looks to international acquisitions.

Technological advances are helping advance biologics development and manufacturing and reduce bottlenecks.

Global product manager at Cytiva, Eric Corti, discusses the challenges with designing a new single-use mixing system that ensures leak-free fluid handling operations at INTERPHEX 2024.

The report covers the major achievements of the office during 2023, including notable drug approvals, publications, guidances, workshops, webinars, and meetings.

In the new draft guidance, FDA provides recommendations on cell safety testing of human-sourced allogeneic cells for sponsor companies.

The CDMO plans to expand and upgrade its Philadelphia, Ohio, and Milan facilities to meet the continued growth in demand for high potency handling capabilities.

Key areas to invest include manufacturing process improvements, quality management, and AI.

In this episode fo the Drug Solutions Podcast, etherna’s vice-president of Technology and Innovation, Stefaan De Koker, discusses the merits and challenges of using mRNA as the foundation for therapeutics in oncology as well as for vaccines.

The non-profit initiative puts collaboration at the forefront as it tackles the challenges surrounding recycling primary pharmaceutical packaging.

The agreement, which will allow participants to share confidential information on medical and medicinal products, builds on the cooperation fostered between the two regulatory authorities during the COVID-19 pandemic.

SK pharmteco, a CDMO, will manufacture, test, and release Adstiladrin (nadofaragene firadenovec-vncg), a gene therapy from Ferring Pharmaceuticals for treating bladder cancer.

The collaboration will combine N4’s nanoparticle delivery system with SRI’s molecular guidance system.

The majority of PMCs/PMRs are proceeding according to schedule.

FDA has granted approval for the use of Novartis’ radioligand therapy, Lutathera, to treat pediatric patients with gastroenteropancreatic neuroendocrine tumors.

In a new agreement, Cellares will utilize its Cell Shuttle fully automated cell therapy manufacturing platform to manufacture select CAR-T cell therapies under development by Bristol Myers Squibb.

A panel of experts went over new regulatory requirements for contamination control and gave guidance on implementing a contamination control strategy in cell and gene therapy facilities at INTERPHEX 2024.

Mary Van Gaasbeck, technical services specialist, LS Equipment and Services, at STERIS Life Sciences, notes that automation is key when it comes to effective sterile powder transfer of parenteral drug products.

Andreas Frerix, product management director for Quattroflow at PSG Biotech, discussed the advantages and new challenges SUTs present for pumping systems.

New regulations, including those put forth by Annex 1, require many pharmaceutical manufacturers to rethink their facility designs to promote compliance.