spacer
home > news > detailed info
INDUSTRY NEWS AND PRESS RELEASES

Sartorius Stedim Biotech Launches New Services for Mammalian Cell Bank Manufacturing

Sartorius Stedim Biotech

Integrated package of new and established services saves time and minimizes risks

Based on these new services, Sartorius Stedim Biotech now offers the manufacture of GMP master and working cell banks (MCB/WCB) for mammalian suspension cells. This activity will be conducted in a custom-designed 260 m2 GMP cleanroom facility that has been audited and approved in 2018 by the Medicine and Healthcare Products Regulatory Agency (MHRA) according to the latest guidelines. Exclusively dedicated to mammalian suspension cell lines, the facility uses selected equipment that enables closed-system manufacture of GMP-compliant cell banks, from vial thaw to automated filling. For maximum process reliability and assurance of sterility, this entire manufacturing service is offered as a fully qualified broth technology platform.

The GMP manufacture of master cell banks is a critical step during the development of biopharmaceutical drugs where time is always key. To ensure the best possible timelines, Sartorius Stedim Biotech cell bank manufacturing is offered in a package along with cell bank characterization services that the company has been providing for more than ten years. The combination of its new manufacturing services and its established characterization service for mammalian cell banks allows clients to work with SSB as a single-source provider from vial thaw to released cell banks.

Up to 500 cell bank vials are produced during a manufacturing run, followed by full characterization, genetic stability assessment in compliance with EU and FDA guidelines, and release by the respective qualified person. The cell bank vials produced are then shipped to the client or transferred to a long-term storage facility. In addition, these cell bank manufacturing and characterization services are a perfect match for the cell line development services based on Sartorius Stedim Cellca’s CHO expression platform. With all three services combined – cell line development, cell bank manufacturing, and cell bank characterization – Sartorius Stedim Biotech supports clients as a total solutions provider from DNA to released GMP cell bank within a 10-month timeline.

“We’re really proud that we now offer even more comprehensive services that can be easily combined with those for CHO cell line development and biosafety. As a result, we provide our clients with an integrated package that saves considerable time and minimizes risks. Furthermore, they will benefit from client-focused customer service with a single point of contact throughout their entire development and manufacturing projects,” stated Lucia Rieger, Product Manager for Protein Expression Systems.
phone 01763 227200
web www.tapbiosystems.com
email York Way, Royston, SG8 5WY, UK
 
Print this page
Send to a friend
   
spacer
News and Press Releases

ERT Continues to Drive Innovation in Virtualization for Respiratory Clinical Trials

ERT, the global leader in clinical endpoints data collection, today announced a strategic partnership with Inofab Health, a healthcare technology company designing and developing ultrasonic spirometry technology for in-clinic and at-home use.
More info >>


White Papers

The Emerging Use of Social Media in Orphan Disease Drug Research

Worldwide Clinical Trials Ltd

The use of various social media platforms, such as Twitter, Instagram, Facebook, and LinkedIn, for dissemination of clinical trial information has created a cornucopia of possibilities enabling clinical trial performance. Characterized by a people-to-people immediacy, social media permits extraordinarily adaptive modification of study information in real-time, and it does so in a highly targeted fashion.
More info >>

Industry Events

12th World Meeting on Pharmaceutics, Biopharmaceutics and Pharmaceutical Technology

8-11 February 2021, Vienna, Austria

In continuation of the very successful scientific meetings in Budapest, Paris, Berlin, Florence, Geneva, Barcelona, Malta, Istanbul, Lisbon, Glasgow and Granada, the 12th PBP World will be held in Vienna from 8-11 Feb 2021. This every two year held conference has gained an ever increasing impact among the pharmaceutical scientists: With up to 1000 submitted abstracts and about 1300 participants it has become a well-established major meeting, attracting scientists from all over the world.
More info >>

 
©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement