From cell line development to advanced analytics, our immersive training programs equip scientists, technicians, and industry professionals with the technical expertise required to succeed in modern biopharmaceutical manufacturing. Combining expert instruction, hands-on laboratory experience, and industry-relevant case studies, these courses provide practical skills aligned with current Good Manufacturing Practice (cGMP) expectations, regulatory standards, and emerging bioprocessing technologies. Developed in partnership with experienced industry practitioners, the program supports workforce development across the biomanufacturing value chain, from upstream process development through downstream purification, quality control, validation, and digital manufacturing.
Course Portfolio
Foundations & Quality Systems
Introduction to Biomanufacturing (3 days)
A comprehensive introduction to biopharmaceutical manufacturing. Participants gain a broad understanding of upstream and downstream operations, aseptic processing, chromatography fundamentals, quality systems, and regulatory expectations while developing practical laboratory skills.
Quality and Compliance (2 days)
Examines the quality systems that underpin successful biomanufacturing organizations. Participants learn quality assurance principles, deviation management, audit readiness, compliance programs, and the critical role of quality culture in regulated environments.
Introduction to Validation (1.5 days)
Introduces validation strategies used to ensure manufacturing systems operate reliably and consistently. Topics include validation lifecycle concepts, regulatory requirements, equipment qualification, environmental monitoring, and applied validation exercises.
Upstream Manufacturing
Introduction to Upstream Aseptic Processing (1.5 days)
Designed for individuals entering bioprocess operations, this course emphasizes aseptic techniques, environmental controls, cell culture practices, and process scale-up methodologies required for successful upstream manufacturing.
Advanced Cell Culture (2 days)
An intensive hands-on course covering mammalian cell culture and upstream bioprocess development. Participants explore CHO cell biology, cell line development, transfection technologies, monoclonal antibody production, cell banking, contamination control, harvest operations, and regulatory considerations essential for commercial biopharmaceutical manufacturing.
Cell Harvest Operations (1.5 days)
Provides foundational training in the technologies used to transition products from upstream cell culture into downstream processing. Topics include centrifugation, precipitation, filtration technologies, process performance metrics, and troubleshooting strategies.
Downstream Processing
Advanced Filtration (2 days)
Explores the principles and industrial application of depth filtration and tangential flow filtration for biotherapeutic manufacturing. Participants develop expertise in process optimization, membrane performance, product recovery, and scale-up considerations through both lecture and laboratory exercises.
Advanced Chromatography (1 day)
Provides a comprehensive and practical understanding of chromatographic purification strategies used throughout downstream bioprocessing. Topics include resin selection, column design and packing, process optimization, and protein purification techniques widely employed in biopharmaceutical manufacturing.
Advanced Purification (2 days)
Focused on commercial-scale purification of therapeutic proteins, this course covers chromatography operations, resin selection, column qualification, process analytics, statistical evaluation, and downstream manufacturing best practices critical to product quality and process consistency.
Analytical Sciences & Product Characterization
Analytical Testing for Biopharmaceuticals (2 days)
Introduces analytical technologies used from raw material qualification through final product release. Participants gain exposure to cell-based assays, ligand-binding assays, analytical chromatography, electrophoresis, spectroscopy, and mass spectrometry while learning the quality and compliance requirements that govern testing laboratories.
Multi-Attribute Method (MAM) Using HRAM LC-MS (3 days)
Introduces advanced liquid chromatography-mass spectrometry workflows for biotherapeutic characterization and quality control. Participants learn how Multi-Attribute Methods enable simultaneous monitoring of critical quality attributes, supporting process development, comparability studies, and product lifecycle management.
Emerging Technologies
Introduction to AI for Biomanufacturing (1 day)
An industry-focused introduction to artificial intelligence and its application across biomanufacturing operations. Participants learn the fundamentals of large language models, AI-assisted process development, validation approaches for regulated environments, and practical deployment strategies that support GxP compliance.
Why Choose this Program?
- Industry-driven curriculum aligned with modern biopharmaceutical manufacturing practices.
- Hands-on training utilizing contemporary bioprocessing and analytical technologies.
- Instruction by experienced biopharmaceutical manufacturing professionals.
- Coverage of upstream processing, downstream purification, analytical testing, quality systems, validation, and emerging digital technologies.
- Professional development opportunities for students, incumbent workers, and industry partners across the biologics manufacturing ecosystem.
- Certificates awarded upon successful completion of applicable courses.