Charles River EndoSafe PTS/MCS system for Endotoxin Testing

RAPID MICRO METHODS PPAR 2013 Jeffrey W. Weber, PAT Project Manager Kalamazoo, MI Oct 2013 Biologics II: RMM Rapid micro-biologic testing - Success stories: in-line TOC, etc.. Value, gaps, and roadblocks - RMM testing and continuous mfg 2 Rapid Micro Methods are ~ 5 years behind PAT systems. J Weber

Opportunity to take lessons learned and apply to RMM arena. Unfortunately consultants are reaping the benefits ($) Lack of guidance and understanding 3 USP <1117> It should be noted that microbiology is a scientifically based discipline that deals with biological principles substantially different from those of analytical chemistry and engineering disciplines. Many times it is difficult for individuals without specific microbiological training to make the transition. 4

PPAR Survey 5 PPAR Survey what is the biggest gap for RMM systems? Staffing Environmental Monitoring 6 Current Micro Lab Testing Other 2% Water 9%

Finish ed 3% 7 Who owns RMMs? RMM Manufacturing (PAT) In-plant testing Raw materials screening Process decisions EMA / EP support QC (Micro Labs) Lean labs More automation Less micro training USP / FDA aligned

Is this an opportunity to align micro with PAT and engineering? 8 Current Micro Testing Raw Materials Discrete point sampling Process / Plant Peopl e

EM Raw Materials Personnel Sterility testing Limited temporal information Retrospective Product Patient 9 all or nothing Silos

Future Micro Testing Raw Materials In t el li ge n Continuous monitoring Holistic control Process /

Plant Raw material characterization is part of process Peopl e ce -b as Product e (I d bM M ) an uf ac

tu ri n Extreme temporal information Infinite sublots g Patient Real Time Release Testing (parametric release) 10 Future RMM Platforms Enhanced COA data

Raw Materials In t el li ge n Automated plate reader Process / Plant Aerosol cytometry Personnel Automated Sample

Peopl e ce -b as Product e (I d bM M ) an uf ac tu ri n Liquid

Bioburden Automated Water Testing Online Water BioBurden Enhanced LIMS / SPC / Cpk - MVDA g Patient 11 Model Implementations Online Total Organic Carbon for Water Minimal regulatory impact to online testing Improved process control over grab samples No guidance from USP, EP or JP initially

for use of online testing ASTM guidance E2656-10 Companies have moved to RTRt water release Business benefit 12 Successful Platforms Technology: Chromogenic Limulus amoebocyte lysate, or LAL assay. USP <85> and EP 2.6.14 Method D. A simplified and rapid endotoxin testing method. Recommended Applications Compendial endotoxin testing Development studies In-process testing System Roles Water testing (routine and post-maintenance) Buffer hold times

Cleaning verification Endotoxin removal efficiency Final Product testing 13 RMM Challenges RMM systems are orthogonal to compendial testing Different units CFU versus BioCounts How to react to new information? Regulatory requirement (i.e. heavy metals) Product Quality Interaction with Regulatory Agencies 14 Industry Perspectives

Pfizer would like to see the development Online Water Testing At-line bioburden BioBurden Testing Simplified testing Online Endotoxin Environmental Monitoring 15 Questions? 16 Traditional Micro Challenges Classic culture assay is

less than perfect! Limi Gro tation o w th Med f ia 106 1 gr o r 1 a m s am 00 m p L wa le ter Microorganisms

103 Culturable Microorganisms Risk Analysis 1 Sampling Limitations http://www.enviroliteracy.org/article.php/58.html 17

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