Manufacturing Chemist’s Post

Catch up with Pharma 5.0 with this edition of the Editor's Pick. #Pharma5 #ManufacturingChemist #Pharmaceuticals #PharmaNews

The pharmaceutical industry is shifting towards a digitalised approach, with many companies adopting novel #AI and machine learning technologies to enhance productivity, accelerate the therapeutic time to market and improve data handling accuracy. However, the regulatory landscape surrounding such technologies is rapidly evolving, and companies must keep up with these changes. Timothy Bubb, the Technical Director at imed , discusses how companies can adhere to the global AI regulations — including the novel EU AI act. #digitalisation #pharma #AIinpharma #AIregulations #medicaldevices #medicalAI

ISO 13485 is the internationally recognised standard for the design and manufacture of medical devices, and assures that products are consistently produced and delivered to meet regulatory and patient requirements. Daniel Gardiner, Quality Manager at Alexander Battery Technologies discusses the impact that such a regulation has had on medical battery manufacturing, and how companies can stay compliant effectively. #pharma #pharmamanufacturing #medicaldevices #ISO13485

As the industry demand for peptide synthesis increases, manufacturing organisations must keep up to remain competitive. There are a range of ways in which companies can produce such proteins at scale, including recombinant and synthetic methods — each with their own pros and cons. In this article, Dr Philipp M. delves into the details of each process, and which may be suitable for your business. #peptidesynthesis #recombinantsynthesis #syntheticsynthesis #proteinmanufacturing #peptidemanufacturing

MedPharm Ltd and Tergus Pharma have joined forces to create a novel CDMO that will operate in the topical and transepithelial #pharmaceutical sector. The strategic merger will combine the expertise of each established #CDMO to bring end-to-end solutions to customers — from the development and manufacture of hormone-based, high-potency drugs to commercial production, serialisation, in vitro testing, clinical manufacturing and existing formulation development. #pharma #drugdevelopment #drugmanufacturing #drugformulation

Eli Lilly and Company has entered into a USD $3.2bn deal to acquire Morphic Therapeutic, a biopharma company specialising in the development of novel therapeutics for a range of #autoimmune, #fibrotic and pulmonary hypertensive diseases. The company's lead asset, MORF-057, targets inflammatory bowel disease through the inhibition of α4β7 integrin, a protein commonly associated with IBD's disease pathology. #IBD #boweldisease #autoimmunedisease #pulmonaryhypertensive #biopharma

Tagrisso plus chemotherapy has been approved by the European Commission for the treatment of adults with EGFR-mutated advanced non-small cell lung cancer (NSCLC) after the positive results of the #FLAURA2 Phase III trial. Tagrisso-chemo exhibited a 38% increase in progression-free survival (PFS) compared with monotherapy. #Tagrisso #cancer #lungcancer #NSCLC #EUapproval #pharmaceutical https://lnkd.in/efuebHeV

CSL Behring B.V. has treated patients with haemophilia B with gene therapy for the first time in Europe. The novel one-time treatment, which stimulates a patient's production of Factor IX (a protein intimately involved in the clotting process), could offer patients a significant improvement in quality of life. #hemophiliaB #haemophiliaB #haemophilia #factorix #genetherapy #celltherapy #blooddisorder https://lnkd.in/eM2JewCU

Freeze drying in the pharmaceutical manufacturing process can pose many risks to employee safety, and stringent regulations must be adhered to. Automation and robotics can assist manufacturers in this, explains GEA Group. #freezing #freezedrying #automation #robotics #pharmamanufacturing #pharma

As #pharmaceutical companies look to reduce the time to market of their drugs while producing quality formulations, the benefits of outsourcing formulation development have become more apparent. Colin Lorimer, Associate Director of Formulation Development at Almac Pharma Services, discusses why companies should consider outsourcing this portion of the development process. #drugdevelopment #pharma #outsourcing #drugformulation Almac Group