5 microbiology spotlight sessions to be covered at Pharma Micro


SMi Pharma is excited to 5 spotlight sessions that will be covered at Pharmaceutical Microbiology West Coast Confex taking place in San Diego this June.

The 5 spotlight sessions being covered at this years West Coast Pharmaceutical Microbiology are by Roche, Genentech, Xellia Pharmaceuticals, Bristol-Myers Squibb and Celgene Corporation, sessions will cover contamination control & microbial identification, Endotoxin testing & LER and Contamination Control considerations for special drug products:

1. Opening Address on Day One: Strategic approaches to contamination control
Regulatory expectations for a contamination control strategy
Types and potential sources of microbial contamination
Best practices in management of microbial contamination, to include best practices in materials management, personnel training and gowning as well as equipment, process, and facility design
Lucia Clontz, Quality Director, Xellia Pharmaceuticals

2. Low Endotoxin Recovery (LER)
What is Low Endotoxin Recovery (LER)?
PDA Technical Report No. 81 Low Endotoxin Recovery
LER impact on product quality
Quality control strategies for LER
Friedrich von Wintzingerode, Senior Manager gASAT Microbiology, Global QC, Roche/ Genentech

3. Just in time release of CAR-T Cell therapies
A patient centric approach for release of CAR-T Cell therapies
Overview of rapid sterility testing of CAR-T therapies
Overcoming challenges and scope for the future
3 key lessons learned from a case study
Irving Ford, Head of CAR T QC Laboratories, Celgene Corporation

4. New endotoxin testing methods – A mass spectrometry based approach
• Mass spectrometry-based testing methods
• Impact of new testing methods on routine practices
• Case study of implementation
Farnaz Nowroozi, Scientist and Manager, Genentech, Inc

5. Implementation of RMM into an effective EM programme
Overview of RMM uses in effective EM programmes
Overcoming issues of implementation
Ensuring compliance
Take away points from a recent case study
Chris Knutsen, Associate Director, Microbiology, Bristol-Myers Squibb PRI

This confex is ideal for those who are interested and work as Senior Microbiologist, Lead Scientist, Laboratory Manager, QA Specialist Drug Substance External Manufacturer, Business Development Manager – Testing, Pharmaceutical Microbiology Consultant, Higher Pharmacopoeial Scientist, Analytical Standards Specialist.

If you are interested in attending you can visit the website http://www.pharma-microbiology-usa.com/PR2, there is also an early bird saving of US$200 which expires on March 29th.

THE EVENT IS SPONSORED BY: Associates of Cape Cod, bioMérieux, Bioscience International, Charles River, DuPont, FujiFilm & Microbiologics

If you are interested in sponsoring, exhibiting or speaking at this event, please contact Alia Malick, Director, on +44 (0) 20 827 6168 or email amalick@smi-online.co.uk

For media enquiries, contact Simi Sapal on +44 (0) 20 7827 6000 or ssapal@smi-online.co.uk

Pharmaceutical Microbiology West Coast
June, 5 – 6 June 2019
Hyatt Regency Mission Bay Hotel, CA, USA

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