While control strategies, including Process Analytical Technology (PAT) and Real-Time Release Testing (RTRT) elements, are common in oral solid dosage forms (with in-process testing and spectroscopic methods widely accepted by health authorities), their application in aseptic manufacturing remains rare. This webinar details a pioneering use case at Roche: the successful integration and regulatory filing of RTRT elements into the release control system of a sterile biotech drug product at a commercial launch site.
Key components of this RTRT control strategy included:
• Implementing a dedicated RTRT sampling point.
• Utilizing Raman spectroscopy as a multi-attribute method.
• Leveraging the existing rapid microbiology toolbox.
The presentation will also address regulatory feedback and lessons learned during this implementation.
Presented by
Lorenz Liesum Head of Analytical Science
Roche
Lorenz Liesum, Head of Advanced Analytical Science at Roche, studied Chemistry and Mathematics in Freiburg and holds a Ph.D. in Physical Chemistry from ETH Zurich. He began his pharmaceutical industry career at Novartis as an analytical scientist in pharmaceutical development. With over 20 years of experience in Process Analytical Technology, he has contributed to several commercial implementations and regulatory filings. Currently, Lorenz works for the global quality control unit at Roche, leading the Instant Release capability team to implement new technologies and control strategies across the internal manufacturing network, with the overall goal of increasing efficiency and reducing lead times in QC.
Followed by
Janosch Antczak Sales Account Manager
Clade
Janosch Antczak is a dedicated sales manager with a passion for the intersection of technology and market success within the biotech and pharmaceutical industries. Currently a Sales Account Manager at CLADE GmbH, he has been integral to the company’s commercial growth since joining in 2020.
Beginning his career at the company (formerly micro-biolytics GmbH) while completing his master’s thesis, Janosch advanced through roles in project management and business development. As part of the business development team, he played a key role in shaping the go-to-market strategy for the biopharma sector. This joint effort led to defining a scalable product line that now constitutes over 90% of new business. In his current sales role, he was part of building a sustainable customer base across Europe and the USA.
Janosch holds a Master of Science in Biotechnical Processes, with a thesis focused on MIR spectroscopy.
Followed by a live Question and Answer Session
Sponsored by
In biopharmaceutical manufacturing, the critical steps of downstream processing and final formulation are often hampered by slow, conventional analytical methods. Optimizing processes like Ultrafiltration/Diafiltration (UF/DF), ensuring correct dilutions, and developing stable formulations requires fast and reliable data. Delays in QC for Drug Substance and Drug Product can create significant bottlenecks, impacting production timelines and costs.
CLADE addresses this challenge directly with a transformative analytical platform. Using advanced mid-infrared (MIR) spectroscopy and intelligent software, we create a complete digital fingerprint of your liquid sample in approximately four minutes. This provides a holistic, real-time view of your product’s state, enabling the simultaneous quantification of multiple critical attributes from one analysis.
Founded in 2001 (as micro-biolytics GmbH), CLADE has over two decades of experience in pioneering spectroscopic solutions. With a dedicated team of over 60 experts, we empower leading biopharmaceutical companies worldwide to optimize their most critical manufacturing and quality control processes.
