samedan logo
 
 
 
spacer
home > ebr > spring 2019 > a new class of innovation
PUBLICATIONS
European Biopharmaceutical Review

A New Class of Innovation

EBR: What promise do advanced therapy medicinal products (ATMPs) offer in terms of treatment?

ATMPs are a rapidly growing, diverse variety of technologies covering a various range of therapeutic areas. The technologies include:

• Autologous cell therapies: Cells removed from a patient, processed in some way, and returned to the same patient
• Allogeneic cell therapies: Cells capable of being banked and can be administered to multiple patients after processing
Ex vivo gene therapies: Autologous or allogeneic cell therapies which are genetically modified as part of the Good Manufacturing Practice process (to correct a faulty gene or target the cell in a predetermined way to, for example, attack a tumour) prior to being returned to the patient
In vivo gene therapies: Direct injection of a viral or nonviral delivery system which will correct one or more faulty genes in the body

Read full article from PDF >>

Rate this article You must be a member of the site to make a vote.  
Average rating:
0
     

There are no comments in regards to this article.

spacer
Dr Angela Osborne is Managing Director at eXmoor Pharma Concepts, which she founded in 2004. Angela has a BSc and PhD in biochemical engineering from University College London, UK, and over 30 years’ experience in biopharmaceutical and cell and gene therapy businesses, processes, and facilities. Her previous roles include Senior Vice President of Pharmaceuticals at Aker Kvaerner and Group Leader of Process Engineering at British Biotech. eXmoor is now a globally recognised biopharmaceutical and cell and gene therapy manufacturing consultancy that has completed more than 300 projects across 12 countries. Angela is also a member of the BioIndustry's Association Cell Therapy Industry Group Advisory Committee and the Manufacturing Advisory Committee as well as the co-founder of the ATMP Manufacturing Community.
spacer
Dr Angela Osborne
spacer
spacer
Print this page
Send to a friend
Privacy statement
News and Press Releases

Nemera joins IPAC-RS as an Associate Member

Nemera is excited to announce that it has become an Associate Member of the International Pharmaceutical Aerosol Consortium on Regulation & Science (IPAC-RS). Nemera’s decision to join IPAC-RS is part of its commitment to advance science and innovation. Nemera is committed to enhancing better patient outcomes by seeking innovative solutions and contributing actively to discussions about the future of drug delivery devices. Its membership in IPAC-RS will facilitate this important commitment.
More info >>

White Papers

Driving ROI: The Case for Investing in Contract & Site Regulatory Document Management Services

DrugDev

With tight timelines and complicated regulatory documentation requirements, getting a clinical trial up and running quickly is easier said than done. Key milestones can be achieved only after the successful negotiation of clinical trial agreements and completion of essential regulatory documents. Many clinical trials are hindered by inefficient, labor-intensive processes. Prolonged, inefficient activation can hamper investigator satisfaction and, ultimately, have a negative bottom-line impact for sponsors and CROs. In addition, the Sunshine Act is heightening the importance of financial disclosure in clinical trials. Without a robust financial disclosure strategy, sponsors cannot ensure that physician self-reported financial disclosure data are aligned with the payment data being reported through the Sunshine Act, increasing financial and regulatory risk.
More info >>

 

 

 

©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement