US legislative update: takeaways for European pharma
Keith A Zullow and Jenny J Zhang from Goodwin Procter examine upcoming US pharmaceutical regulation and how, if passed, it could impact European pharma/biopharma looking to access the US market.
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Keith A Zullow and Jenny J Zhang from Goodwin Procter examine upcoming US pharmaceutical regulation and how, if passed, it could impact European pharma/biopharma looking to access the US market.
4 November 2022 | By
Could the new wave of taxane chemotherapies succeed where traditional chemotherapies have failed? Colin Freund, Chief Executive Officer of Modra Pharmaceuticals, reveals the benefits of this emerging generation of anticancer treatment.
First-in-human clinical verification is one of the first critical milestones in drug development. Abhijeet Sinha, Senior Scientist at Lonza Small Molecules, exemplifies the imperative of solving drug development challenges in the early phases.
27 October 2022 | By
Articles in this drug formulation In-Depth Focus explore the design of formulations using cyclodextrins, plus the development of orally-delivered taxane chemotherapies.
In this Guide to Outsourcing & Testing, EPR explores trends in the pharmaceutical outsourcing market. Plus, Charles River discusses solutions for tracking, trending and microbial identification and Associates of Cape Cod International showcases its endotoxin testing capabilities.
Size exclusion chromatography (SEC) is routinely used in the pharmaceutical industry to characterise the higher and lower molecular weight species proteins. Here, Gregory Webster, Senior Principal Research Scientist in Analytical Research and Development at AbbVie, explores the challenges, opportunities and optimisations needed to execute design of experiment studies to project…
Having recently conducted a project to implement more sustainable, reliable and efficient bacterial endotoxin testing across the global Roche corporation, those involved in the project discuss with EPR’s Hannah Balfour the key takeaways from their implementation and validation, as well as current trends in bacterial endotoxin testing.
Are you leveraging all the information from your QC data? A secure, compliant and powerful data management tool is critical for maintaining a state of control.
Identification of environmental isolates is a regular requirement in pharmaceutical manufacturing, and strain differentiation can be valuable in a variety of circumstances. There have been huge advances in the technology available for sequencing bacterial genomes, which has fed through to the analyses that are available to pharmaceutical microbiologists. NCIMB’s Identification…
Cyclodextrins are a frequently used excipient in the pharmaceutical industry, employed in multiple dosage forms and with multiple purposes simply because of their numerous positive properties, including being generally well tolerated and safe. In this short article, René Holm, Professor in pharmaceutical physical chemistry at the University of Southern Denmark,…
A new age of sustainability: discover how ACC’s PyroSmart NextGen® recombinant Cascade Reagent (rCR) enhances bacterial endotoxin testing (BET).
Here, Jason Fontenot, Chief Scientific Officer of Sangamo Therapeutics, discusses with EPR’s Hannah Balfour how the industry is developing chimeric antigen receptor (CAR) T regulatory cells (Tregs) as a potentially paradigm-shifting therapeutic option for conditions driven by the immune system, such as autoimmunity and transplant rejection.
Pharma 4.0 is coming and is further driven by the recent update of the EU GMP Annex 1 regarding manufacturing of sterile medical products, setting new regulatory expectations in all manufacturing processes. Here, Isabella Jul-Jørgensen from the University of Denmark focuses on sterile water quality and how the new requirements…
Dave Elder explores US patent developments amid growing concerns that current approaches potentially delay generic drugs and biosimilars entering the market.
Features in this in-depth focus review the advances in bacterial genome sequencing and its role in pharmaceutical microbiology, as well as key considerations for when implementing and validating recombinant Factor C (rFC) endotoxin testing. Plus, coverage of how proposed US pharmaceutical regulation could impact European companies, in-house lentiviral vector manufacturing…