Development and Validation of Automated Rapid Protocols to Ensure Mycoplasma-Free Biologics

Development and Validation of Automated Rapid Protocols to Ensure Mycoplasma-Free Biologics

Tuesday, October 8, 2024 2:45 PM to 3:10 PM · 25 min. (Europe/Madrid)
Hall 5 - 5B49
Manufacturing 5.0
Product Innovation

Information

Testing for Mycoplasma is essential to ensure safety of biopharmaceutical products. With over 200 recognized species, Mycoplasmas are common contaminants in manufacturing facilities and cell-derived biologics. Existing compendial methods are complex and lengthy. PCR-based methods, while faster, can be limited in sensitivity. To overcome these challenges, we have developed novel protocols based on the Applied Biosystems™ MycoSEQ Plus quantitative PCR method combined with automated DNA extraction.

Our protocols were validated with live Mycoplasma species to meet regulatory requirements. The sensitivity, sample volume and turnaround time surpass compendial culture method results. Our testing protocols are suitable for testing a variety of samples, including raw materials & final products, samples that interfere with traditional culture and PCR method, and complex samples such as cell and gene therapy products.

This session discusses how our new testing protocols can benefit biologics companies and help accelerate the manufacturing process for cell and gene therapies.

Thermo Fisher Scientific7B18Thermo Fisher Scientific provides industry-leading pharma services solutions for drug development, clinical trial logistics, and commercial manufacturing through our Patheon brand. We partner with customers in the pharmaceutical, biotech, and life science industries as their trusted CDMO to deliver medicine to patients faster. We believe that doing this successfully not only requires science, technology, and world-class expertise, but also requires a strategic partnership - bonded by key elements such as trust, communication and collaboration. We embed these elements into every operation, interaction, and step in the drug development journey. With more than 60 locations around the world, we are committed to providing Accelerator(TM) Drug Development, 360˚ CDMO and CRO solutions, to support our customers' aspirations to get treatments to patients, faster. Our pharma services include API, biologics, cell therapy, viral vectors, formulation, clinical trials solutions, logistics services, commercial manufacturing, and packaging. We couple our scientific and technical excellence in all areas with a strategic partnership, to provide customers of all sizes access to a global network of facilities and dedicated experts across the Americas, Europe, Asia, and Australia. At Thermo Fisher Scientific, we understand that developing novel therapies and moving them from discovery to patients is a complex, high-risk process. Every customer has different needs, and every newly discovered drug has a unique pathway to reach the market. As a global, full-service CDMO and CRO partner, we help our partners bring innovative molecules and life-changing therapies to market as efficiently and safely as possible.

Registered attendees

Bernardo Augusto Estupinan Gaisbauer
Bernardo Augusto Estupinan Gaisbauer
Managing PartnerCDMO Advisor LLC

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