Outsourcing regulatory activities in pharma
Here, EPR's Caroline Peachey explores some key considerations, approaches and strategies for pharmaceutical companies looking to outsource regulatory activities.
List view / Grid view
Here, EPR's Caroline Peachey explores some key considerations, approaches and strategies for pharmaceutical companies looking to outsource regulatory activities.
To facilitate Quality by Design (QbD) in becoming a true standard approach for drug development, pharma should attend regulatory expectations and pursue innovative frameworks that guarantee high-quality levels, researchers urge.
The new acquisition grants AstraZeneca rights to a new CAR-T cell therapy with a differentiated manufacturing process that could provide a potential best-in-class blood cancer treatment.
Driven by technological advances there is now increased scope for point-of-care manufacturing of CAR T-cell therapy. Arnon Nagler, Professor of Medicine at Tel Aviv University, discusses key benefits, challenges and lessons learned from developing an in-house programme.
Contract development and manufacturing organisation, Piramal Pharma Solutions, has expanded its antibody drug conjugate manufacturing facility in Scotland.
Caroline Peachey chats with Mahesh Bhalgat, COO at Syngene International Limited about the role of new technology in biotherapeutics production.
EPR wraps up the year with a selection of top stories from 2023, highlighting key trends and topics such as environmental monitoring (EM), quality (QA/QC), manufacturing, regulation and clinical development.
The facility in Athlone, Ireland, will give Novo Nordisk additional capacity to manufacture oral products.
15 December 2023 | By Lonza Capsules and Health Ingredients
Pharmaceutical companies are under constant pressure to create improved, lower risk and cost-effective drugs faster. The Lonza Capsule Application Lab services can augment your existing research and development to meet stringent requirements.
Lek Pharmaceuticals, part of Sandoz, has started building a $400 million biologics manufacturing centre in Slovenia.
In this video, experts from Curia discuss trends in the pharmaceutical industry, including move to adopt continuous flow chemistry processes for both mRNA and small molecule manufacturing.
Interested in scientifically sustainable endotoxin testing? Discover more about Endosafe® Trillium™ recombinant cascade reagent (rCR)
Krishna Venkatesh, Global Head Sterile Operations at Dr Reddy's Laboratories discusses how and why the pharma industry is embracing automation.
In this podcast, Dr Salim Benkhalifa, Medical Affairs Lead, Celltrion Healthcare France reflects on biosimilars development.
(Bio)pharmaceutical manufacturing is changing considerably, with key innovations enabling companies to rethink R&D, manufacturing, quality control and quality assurance (QC/QA) operations. The spotlight is squarely on process analytical technology (PAT), which underpins the successful transition towards highly effective advanced manufacturing strategies. Martin Gadsby, Chairman of Optimal Industrial Technologies, looks at how this transformative approach…