More bioprocessing and biomanufacturing – Page 5
-
ArticleTargeted therapies for chronic lymphocytic leukaemia in an evolving treatment landscape
Dr Mehrdad Mobasher, Chief Medical Officer for Hematology, BeiGene, discusses the evolution of therapies for chronic lymphocytic leukaemia (CLL), the promise of targeted treatments and what could be on the horizon of the therapeutic landscape for this disease.
-
ArticleRegulating therapies for rare diseases – recent approvals
This article summarises some of the recent notable drug approvals in the EU and US, including a gene therapy and an enzyme replacement therapy.
-
ArticleAlzheimer’s drug development roundup – July 2024
From exciting data on cell therapy and monoclonal antibodies, through to new regulatory developments, this article summarises some of the key developments within the Alzheimer’s therapeutic landscape over July.
-
ArticleA holistic approach to safeguard data integrity in Biopharma manufacturing
Data integrity is critical in Biopharma manufacturing yet is often difficult to achieve due to complex regulatory requirements and legacy data management systems, among the many factors. Furthermore, issues such as data accuracy, completeness and security impact product quality, regulatory compliance and ultimately patient safety. Addressing all these challenges demands ...
-
ArticleThe route to enhanced gene therapies
In this article, Roger Palframan, Head of US Research at UCB, delves into the potential of gene therapy and which modalities have the most promise, what the industry should prioritise to advance the field, as well as what is needed to develop the workforce.
-
ArticleImproving aseptic connections throughout the manufacturing process
As companies are adapting to EU GMP guidelines for Annex 1 - Manufacture of Sterile Medicinal products, there have been numerous discussions involving the terms sterile and aseptic, as if they were synonymous. Vanessa Vasadi Figueroa, Chief Microbiologist at VVF Science® and Executive Director of Microbiology & Sterility Assurance at ...
-
ReportPharma Horizons: Formulation
European Pharmaceutical Review’s latest Pharma Horizons report provides insight on key developments within pharmaceutical drug formulation for drug development, pharmaceutical manufacturing and quality control.
-
ArticleUncovering the potential of ADCs to target tumours
Antibody drug conjugates (ADCs) are set to play a pivotal role in the future of oncology, thanks to their potential to offer targeted treatments with a lower risk of side effects. Here, Mary Jane Hinrichs, Senior Vice President of Early Development at Ipsen, examines how ADCs could transform treatment options ...
-
ArticleCleanroom microbiology: single-temperature incubation for EM
Single-temperature incubation has been discussed for a long time in the pharmaceutical industry but only a few sites have implemented this system. Here, Guillaume Pinon, Head of the Microbiology Lab at Servier, discusses the use of single-temperature incubation in an aseptic production facility, outlining the regulatory considerations, strategic approach, challenges ...
-
ArticleProdrugs: seeking perfection in an imperfect world
Balancing safety, efficacy and cost in drug development is challenging. Prodrugs offer potential solutions, but also introduce additional complexities, as Dave Elder explains.
-
ArticleContinuous manufacturing: an evolving technology for drug substance manufacturing
Continuous chemical manufacturing technology has been in use for more than 100 years producing high-volume commodity chemicals. However, it was not until the early 2000s that the technology caught the attention of the pharmaceutical industry in a significant way.
-
ArticleCombining biofermentation and chemical synthesis to manufacture complex molecules in pharmaceutical applications
It is well known that nature, being a rich source of bioactive natural products, offers up a massive number of candidate drugs for the pharmaceutical industry. David Blanco, Industrial BD and CDMO Director at Suanfarma CDMO, reveals why biofermentation benefits from additional processing to produce a viable drug candidate.
-
ArticleGuide to Data Integrity 2024
In this Guide to Data integrity articles explore the role of data integrity in CCS, AI and ML as well as biopharma manufacturing.
-
ArticleQA/QC Microbiology In-Depth Focus 2024
This in-depth focus features articles on single temperature incubation, endotoxin standards and aseptic connections in pharmaceutical manufacturing.
-
ArticleEuropean Pharmaceutical Review Issue 3 2024
European Pharmaceutical Review Issue 3 includes articles on microbiology, downstream bioprocessing and drug development. Register your details now to download this exclusive content.
-
ArticleDrug approval roundup – May/June 2024
This article highlights some of the key regulatory approvals granted in May and June in the EU and US so far this year, including for oligonucleotide and biologic therapies.
-
ArticleBig potential for small molecule drugs in cancer treatment
With recent recommendation of Takeda’s fruquintinib by the European Medicines Agency (EMA), EPR spoke to Dr Sebastian Stintzing, Professor of Medicine, Head of the Department of Hematology, Oncology, and Tumor Immunology (CCM) of The Charité University Hospital in Berlin and investigator on the FRESCO-2 trial, to find out more about ...
-
ArticleModifier gene therapy - clinical development and manufacturing considerations
Expanding on his earlier podcast discussion with EPR, Dr Arun Upadhyay, Chief Scientific Officer and Head of Research & Development at Ocugen, discusses the company’s promising modifier gene therapy candidates for ophthalmic disorders.
-
ArticleDeveloping the EU’s first intestinal microbiota-based biologic
In this final installment of EPR's Microbiome therapeutics: microscope to medicine, Dr Olaia Aurtenetxe, Head of Clinical Research at Mikrobiomik, reveals study data demonstrating why MBK-01, an investigational drug based on faecal microbiota transplantation, presents a promising alternative to the current standard of care for Clostridioides difficile infections (CDI), potentially ...
-
VideoWebinar: Overcoming contamination risks during biologicals production: Mycoplasma & virus testing
Listen to the discussion on contamination risks in biomanufacturing, featuring mycoplasma and virus testing per European Pharmacopoeia and USP standard.