samedan logo
 
 
 
spacer
home > pmps > winter 2003 > reinventing biopharmaceutical manufacturing with single-use disposable systems
PUBLICATIONS
Pharmaceutical Manufacturing and Packing Sourcer

Reinventing Biopharmaceutical Manufacturing with Single-Use Disposable Systems

Advancements in biotechnology and bioprocessing are driving the rapid development, commercialisation and availability of biopharmaceuticals globally. The US Department of Commerce reported in 2003 that there were more than 370 biotech drugs and vaccines in clinical trials in the US. Additionally, of the 155 biotechnology drugs and vaccines that have received regulatory approval from the Food and Drug Administration (FDA) to date, 70 per cent of these have been in the last six years (1).

Technological breakthroughs have resulted in an unprecedented number of drugs and biologics currently in research and development phases. Biopharmaceutical manufacturers face increased pressure to commercialise new and unique therapies faster and at lower cost. As a result, production demand is outpacing available manufacturing capacity. To meet existing and future demand and maintain a competitive advantage, many manufacturers are striving to develop increased efficiencies within their manufacturing processes.


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
By Carolyn Franceschi, Medical Business Unit Manager at Colder Products Company

Carolyn Franceschi is Business Unit Manager for Medical Products at Colder Products Company. Carolyn is a member of the Biomedical Engineering Institute at the University of Minnesota, MNBIO, and Medical Alley. She holds a BS in Biology from Rochester Institute of Technology.

spacer
Carolyn Franceschi
spacer
spacer
Print this page
Send to a friend
Privacy statement
News and Press Releases

Janssen Announces Phase 1 Results for Bispecific Antibody Amivantamab in the Treatment of Patients with Advanced Non-Small Cell Lung Cancer Harbouring Exon 20 Insertion Mutations

BEERSE, BELGIUM, May 18, 2020 The Janssen Pharmaceutical Companies of Johnson & Johnson today announced results from the Phase 1 CHRYSALIS study evaluating amivantamab (JNJ-6372) in the treatment of patients with advanced non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) Exon 20 insertion mutations.[i] Amivantamab is an EGFR and MET-targeted bispecific antibody, which targets activating and resistance EGFR mutations, and MET pathway activation.[ii],[iii] Investigators assessed efficacy using overall response rate (ORR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1), duration of response, as well as the safety profile of amivantamab,1 which were the basis of the U.S. Food and Drug Administration (FDA) Breakthrough Therapy Designation granted earlier this year.[iv]
More info >>

White Papers

A Rules Based Approach to Labelling and Artwork Management

Kallik

Many organisations today are experiencing unprecedented demands from regulatory authorities and consumers alike for product labelling to be made clearer and more informative. Forthcoming regulations (including the new EU MDR regulations coming into force May 2020) also require that labelling content to be published electronically in addition to print. As companies seek to continuously differentiate themselves in established markets as well as gain entry into new territories, the increase in both volume and complexity of product and market variations will have a direct impact on labelling.
More info >>

 

 

 

©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement