Latest News

Biologic Facility Upgrade

Written by: Life Science Associates On: May 25th, 2010 Posted in: Case Studies
Problem

This was a brown field site that urgently required upgrading if it was to remain viable. Previous designs had involved expanding outside the footprint of the existing site or moving to a green field site. None of these designs could be justified because of unattractive cost benefit scenarios. Upgrading within the footprint of the original site had previously been considered impractical.

Solution

We worked with the client and their consulting engineers over a period of two months on the problem. Using some advanced design techniques we were able to help the client produce a modular design within the existing footprint of the site. This meant that the site could be upgraded in a modular fashion with minimum disruption to production. The cost of the design process was estimated to be in the region of 30% of the spend using a more traditional engineering approach and was completed in a third of the time. After a number of unsuccessful attempts over the last 6 months to secure the funds to upgrade the facility, the project was finally approved by the board.

Lonza Accelerates Clonal Cell Line Constructions – Jan 2010

Written by: Life Science Associates On: May 19th, 2010 Posted in: Life Science News

Scientists at Lonza Biopharmaceuticals have developed a new cell line construction process that rapidly generates clonal cell lines to deliver cGMP materials in 14 months from the receipt of DNA sequence. Called “One-Step,” this cell line construction process uses chemically defined, non-animal origin components; the process also includes cell line stability testing, stringent selection to isolate high-yielding cell lines, procedures and datapack to support monoclonality and regulatory support.“This new clonal cell line construction process … gives customers high-quality results faster than ever before,” said Allison Vernon, head of Lonza Biopharmaceuticals Mammalian R&D Services, in a press statement.

LSA Comment – We are very proud of the fact that 3 LSA associates Smith, Schurr and Yeomens worked with the Lonza Biologic’s team on this breakthrough project. We helped the Lonza  design team to apply generic design concepts to the design of this new process. Adrian Haines, Ph.D., Senior Group Leader, Cell Culture Process Development,  Lonza; will be speaking in San Francisco about some of the scientific and technological aspects of this project at the IBC’s 6th annual conference on Cell line development and engineering taking place June 21 – 23, 2010 · San Francisco Airport Marriott · Burlingame, CA.

March 10-12 QbD Advanced Skills Event – BBTC Newcastle University

Written by: Life Science Associates On: May 19th, 2010 Posted in: Life Science News

LSA’s Smith and Schurr conducted a successful QbD advanced skills training event at the Biopharmaceutical Bioprocessing Technology Centre, University of Newcastle. The course was attended by representatives from both industry and research. The 2 days provided the participants with a framework for applying QbD principles to both new and existing products/ processes. Delegates were able to test this framework by applying it to a practical simulation. The course was very well received by the participants and the framework that was used during the course is already being piloted by one of the delegates in their own organisation. This initiative was part of a broader collaboration between the BBTC and LSA. LSA associate Craig Smith is working closely with BBTC to help them realign their post-graduate curriculums to support industries attempt to manage their products and processes within the context of the QbD philosophy.

High Performance Lab – Large Molecules

Written by: Life Science Associates On: May 17th, 2010 Posted in: Case Studies
Problem
Average lead times in the QC laboratory exceeded 30 days resulting in high levels of raw material inventory
Result
We worked with the client to reduce lead times by 50% and inventory was reduced by 1 million Euros.