Adma Biologics Inc · NASDAQ:ADMA
Adma Biologics — Conference Presentation (2024)
11 slides from Adma Biologics's conference presentation, Mar 22, 2024
Slide 1: Gloveless Robotic Isolator Technology: Mitigating Biopharma Industry's Implicit Biases on Contamination Control
Gloveless Robotic Isolator Technology: Mitigating Biopharma Industry's Implicit Biases on Contamination Control from an Early Adopter of Advanced Aseptic Technology Joseph McCall ADMA Biologics
Slide 2: Disclosure
Disclosure • Joseph McCall, Co-author, ADMA Biologics, Ramsey NJ • Jeffrey Gruenglas, Co-author, ADMA Biologics, Ramsey NJ This content was funded by ADMA Biologics. The authors have no other financial relationships or affiliations to disclose. 2
Slide 3: Contents
Contents • Conventional vs Advanced Aseptic Technologies • Overcoming Barriers to Implementation • Decontamination Cycle Validation • Environmental Monitoring 3
Slide 4: Electric Vehicles (EVs) & Advanced Aseptic Technologies
Electric Vehicles (EVs) & Advanced Aseptic Technologies 4
Slide 5: Conventional Aseptic Processing
Conventional Aseptic Processing • Inherently risky • Fundamentally unchanged since 1960s • Susceptible to external microbial & particulate contamination • Cleanroom personnel pose the greatest risk for contamination of the Critical zone • Extensive training of personnel in aseptic practices, princip
Slide 6: Advanced Aseptic Technology: Closed Robotic Isolator
Advanced Aseptic Technology: Closed Robotic Isolator • Validated vapor-phase hydrogen peroxide (VPHP) auto decontamination cycles • Sterile Single Use product flow path / fill needle • No glove ports • No operator interventions • Non-aseptic set up • Pressurized w/auto leak detection • Prohibits ope
Slide 7: Barriers to Implementation
Barriers to Implementation Validation of Vapor-Phase Hydrogen Peroxide Decontamination Cycles • Standard validation 6-log Biological Indicators (BIs) − >1M CFU (colony forming unit) per carrier • Resistant species: Geobacillus stearothermophilus (thermophile) • Same method as sterilization chamber (
Slide 8: Optimized VPHP Cycle Using 4-Log BIs
Optimized VPHP Cycle Using 4-Log BIs Total Kill analysis method Parameter Initial Optimized • Same species: ~50K CFU per BI Biological >106 endospore >104 endospore • Same BI locations Indicator population population • Lower dose VPHP Dose 8.9 mL 3.3 mL • Shorter dwell time • Higher ppm H2O2 VPHP Dw
Slide 9: Barriers to Implementation
Barriers to Implementation • External contamination risk Cultivation Based Environmental Monitoring eliminated • Closed isolators don’t easily accommodate conventional EM testing • Inherent risk of contaminating the test during handling • Availability of rapid microbiology methods • Exceptionally lo
Slide 10: Environmental Monitoring for Closed Robotic Workcells Used in Aseptic Processing
Environmental Monitoring for Closed Robotic Workcells Used in Aseptic Processing Data to support advanced environmental monitoring strategies “This should be required reading for anyone not using isolation or closed system technologies. If you are using anything less capable than what is described i
Slide 11: Thank you!
Thank you! 11