Single use systems and process aids play a key role in the manufacturing process of biopharmaceutical products. These components are often used in critical part of the process and consistent performance and quality level is required to meet the expectations of regulatory agencies and end-users. Change and variability in the design, manufacturing or final treatment may result in a modification of the functional and quality profile of the material and it can influence the quality attributes of the drug substance and the drug products. In this webinar, we will review the strategies to monitor and control variability in process materials and assess the impact on biopharmaceutical products.
Presented by Paolo Grisostomi, Senior Engineer, Materials Science at Biogen

Paolo Grisotomi joined Biogen in 2018 and he currently holds the position of Senior Engineer, Materials Science, at the Biogen Next Generation Manufacturing site in Switzerland. In his role, Paolo has oversight of several areas of raw materials, single use systems, materials investigation, and serves as SME for Extractables and Leachables at the site. Previously, he covered leading position in chemistry, biophysics and analytical development groups in pharmaceutical companies where he gained extensive experience in process development and material characterization and design. Paolo has 20 years of experience in the pharmaceutical industry and he holds a master’s degree in Pharmaceutical Chemistry and Technology from Univerità degli Studi di Camerino (Italy)
Donald Young, Sr. Product Manager at Thermo Fisher Scientific

Donald Young is the Senior Global Product Manager for BioProcess Containers, at Thermo Fisher’s BioProduction Division facility in Logan, Utah.  Don has 14 years’ experience as a product manager as well as 12 years of experience working as a medical science liaison in the pharmaceutical industry.  Don helps in the management of pricing, supply chain, film portfolio, training, and product customization at Thermo Fisher Scientific’s BioProduction Division in Logan, Utah. Don holds and Bachelor of Arts degree in Biology, and a Master of Science degree in Public Health.

x-ray processing as a gamma irradiation modality – overview and preliminary results

Single-Use Technology (SUT) product usage in large-scale manufacture of biopharmaceuticals is a result of their demonstrated performance, cost-saving, and time-saving benefits. These advantages reached new heights during the SARS-CoV2 pandemic.  The pandemic exposed several weaknesses in the SUT product supply chain.  In addition to material shortages, access to gamma irradiation processing – which is central to SUT’s ready-to-use convenience – was identified as a process constraint.  The finite supply of Cobalt-59 and its conversion to Cobalt-60 constrained the SUT product supply chain in ways not considered, pre-pandemic.
SUT suppliers quickly identified x-ray processing as a method to achieve the same gamma irradiation modality.  Common to both food and medical device industries, x-ray has proven performance record, but was never considered by the SUT market. The recent pandemic changed that.  SUT product suppliers are now pursuing x-ray processing as an alternate gamma irradiation technology.
This presentation discusses x-ray as a method to achieve the same irradiation modality and describes one supplier’s characterization strategy as well as sharing some preliminary testing results.
Dr. Sona Kovackova, Study Director Small Volume Parenteral applications, Nelson Labs Europe

Dr. Kovackova holds a PhD degree in Organic Chemistry from the University of Chemistry and Technology, Prague, Czech Republic. She started her career as a Scientist at the Rega Institute for Medical Research KU Leuven, Belgium and later worked in Quality Control of medicines at the Belgian Institute of Public Health.
In 2017, Dr. Kovackova took the position of Study Director at Nelson Labs Europe. Sona currently specializes in Extractables & Leachables studies with a main focus on injectable applications.

The new PQRI-PDP Recommendations and Biologics: what is there to learn and what is the impact on the study design for an E/L study?

Earlier this year, the final recommendations of the Product Quality Research Institute (PQRI) were published for Parenteral Drug Products (PDP’s). Apart from the wealth of information and considerations on how to design extractable & leachable studies for parenteral drug products in general, it also contains a lot of valuable information on specific considerations for biological products. For biological products, not only the safety but also the quality of the product and related concerns about immunogenicity and leachables reactivity come into play. With this presentation, we will provide an overview on the recommendations that can be found in the PQRI-PDP document and how it could affect the design of an extractable & leachable study for the primary packaging of biologics.
Sponsored by Nelson Labs and Thermo Fisher Scientific

 
About Nelson Labs
Nelson Labs, A Sotera Health company, is the leading, global provider of lab testing and expert consulting services. We perform microbiological and analytical laboratory tests across the medical device, pharmaceutical, and tissue industries. The company is regarded as a best-in-class partner with a strong track record of collaborating with customers to solve complex problems. We have over 700 scientists, technicians, and service specialists who diligently perform more than 700 rigorous tests in 13 global laboratory locations.
Based in Belgium, Nelson Labs Europe specializes in providing premium Extractables & Leachables testing services to the pharmaceutical and medical device industries. We also support pharmaceutical companies across the globe in developing worldwide compliance testing strategies to qualify container/closure applications and pharmaceutical production equipment from an Extractables & Leachables perspective.
About Thermo Fisher Scientific
Thermo Fisher Scientific supports developers and manufacturers of biological-based therapeutics and vaccines with a world-class product portfolio that spans the bioprocessing workflow from discovery through large-scale commercial production. Starting with production-grade raw materials and supply chain logistics, we provide solutions and services across the manufacturing value stream and through QC release of finished goods, including upstream cell culture, downstream purification, analytical and QC testing, end-to-end single-use technologies, and comprehensive measurement and control solutions.