Regulatory and manufacturing requirements exist to perform product-specific microbial retention testing on sterilizing filters.  The implementation of a Quality by Design approach to microbial retention testing supports a paradigm that would obviate the need for product-specific testing for early-stage products that do not have the quantity of material required to easily and efficiently perform such testing.  Process and product parameters were varied to determine their effect on microbial retention. To minimize the burden of filter validation retention studies for early-stage (Phase 1) manufacturing, it is recommended that manufacturers perform a risk assessment to confirm their product and process conditions are within the established design space.

Presented by Jennifer Juneau, Senior Principal Scientist at Pfizer

Jennifer Juneau is a Senior Principal Scientist with over 30 years experience in Pharmaceutical Research and Development at Pfizer, Andover MA.  She has developed and transferred both liquid and lyophilized drug product manufacturing processes for several commercial products and many clinical products.  Her area of responsibility and expertise include process/product development, scale-up, tech transfer, and filter validation.  She received her Bachelors degree in Chemical Engineering from Worcester Polytechnic Institute (WPI). 

Assuring performance in sterilizing filters: a supplier’s perspective

The implementation of a Quality by Design approach to how sterilizing filters are designed, validated and manufactured illustrates how filters are designed to meet regulatory and industry requirements for sterility assurance. Critical process parameters are monitored to ensure consistent quality of the product, supporting the requirements for sterility assurance. This approach will be discussed, as well as studies that varied process and product parameters (pressure, product concentration, time, temperature) to determine their effect on microbial retention, data which can be used to define a design space for pharmaceutical manufacturers.

Presented by Annie Leahy, Senior MSAT Manager at MilliporeSigma

Annie Leahy is an Senior MSAT Manager in the North American Manufacturing Sciences and Technology (MSAT) group within MilliporeSigma. She leads a highly technical team that ensures successful implementation and ongoing operation of customer applications across the manufacturing process. Her area of expertise focuses on virus and sterilizing filtration operations, supporting customers during their manufacturing process to provide best practices and ensure optimal processing conditions. Annie has over 15 years of experience, which has included developing improved methods for virus spike preparations and mycoplasma retention methods as well as conducting virus and sterilizing filtration applications studies at both small and large scale. She holds a BS in Biology from Dickinson College and an MS in Biotechnology from Northeastern University.

Followed by a live Questions and Answers session

Sponsored by MilliporeSigma

The Life Science business of Merck KGaA, Darmstadt, Germany, which operates as MilliporeSigma in the U.S. and Canada, has more than 27,000 employees and more than 55 total manufacturing and testing sites worldwide, with a portfolio of more than 300,000 products focused on scientific discovery, biomanufacturing and testing services. Merck KGaA, Darmstadt, Germany, a leading science and technology company, operates across healthcare, life science and electronics.

Around 63,000 employees work to make a positive difference to millions of people’s lives every day by providing products and services that accelerate drug development and manufacturing. In 2023, Merck KGaA, Darmstadt, Germany, generated sales of € 21 billion in 65 countries.

The company holds the global rights to the name and trademark “Merck” internationally. The only exceptions are the United States and Canada, where the business sectors of Merck KGaA, Darmstadt, Germany, operate as MilliporeSigma in life science, EMD Serono in healthcare and EMD Electronics in electronics. Since its founding in 1668, scientific exploration and responsible entrepreneurship have been key to the company’s technological and scientific advances. To this day, the founding family remains the majority owner of the publicly listed company.