BioHub Maryland®

Courses & Programs

COURSES AND PROGRAMS

For more information on customized courses or to sign up for short courses please contact Alex Haarich, Manager of Workforce Development and Partnerships at Alex@mdtechcouncil.com.

Introduction to Biopharma Manufacturing

This half day session at the BioHub Maryland Education and Training Center at Montgomery County is for anyone interested in learning more about biopharmaceutical manufacturing. It will take attendees through the basics of biopharmaceutical manufacturing as well as some of the most exciting and impactful trends in the industry such as how single-use technologies are being utilized in the sector. Whether you work in the production area, are a hiring manager, a recruitment consultant or a vendor, this course is for you.

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Introduction to Upstream Processing

This course includes both hands-on practical and theory components covering cell vial thaw, aseptic techniques, cell counting, metabolic analysis, scale up, and bioreactor operation. Equipment such as biosafety cabinets, cell culture consumables, wave bag reactors, stirred-tank reactors, as well as single-use bioreactors will all be utilized to reflect the current state of biopharmaceutical manufacturing technology.

Introduction to Downstream Processing

This course includes both hands-on practical and theory components covering topics including clarification, ultrafiltration/diafiltration, viral clearance, and chromatography. Participants will be introduced to the basics of filtration and chromatography in a theory session before building on this knowledge and performing these operations using a practical component.

Introduction to QC Micro Skills for Biopharma

This 3.5-day course is designed to equip QC Microbiology analysts with the main theory and practical experience required to develop their skills in a GMP biopharmaceutical microbiology laboratory.  The course will cover microbiology basics in the classroom-based lectures and lab-based practical sessions, including Growth Promotion Testing and BI Processing, Environmental Monitoring, Water Sampling, Bioburden and Sterility testing (using rapid micro methods) & Endotoxin testing (using recombinant Factor C technology, Microbial Identifications, and Mycoplasma testing). The course will also include an overview of how to approach deviations and investigations.

Introduction to Gene Therapy Manufacturing

This 2.5-day course provides essential knowledge of Gene Therapy manufacturing processes for safe, effective production and regulatory approval. The course offers hands-on experience with the latest technologies for GMP manufacturing of gene therapies. Lectures will cover technologies, processes, and regulatory considerations for gene therapy manufacturing, ensuring participants are well-prepared for gene therapy production.

Introduction to Cell Therapy Manufacturing

This 2.5-day course provides essential knowledge of Cell Therapy manufacturing processes for safe, effective production and regulatory approval. The course offers hands-on experience with the latest GMP technologies for CAR-T and stem cell therapy manufacturing. Lectures will cover technologies, processes, and regulatory considerations for cell therapy manufacturing, ensuring participants are well-prepared for cell therapy production.

Introduction to ATMP Manufacturing

Understanding Advanced Therapy manufacturing processes is crucial for safe, effective production and regulatory approval. This course, provides practical, hands-on experience with the latest technologies for manufacturing of gene therapies, CAR-T cell therapies, and stem cell therapies. In addition, and to facilitate deeper theoretical understanding, lectures will cover technologies, processes, and regulatory considerations for Advanced Therapy manufacturing.

Introduction to Commissioning, Qualification, and Validation

This comprehensive 2-day course introduces the typical Commissioning, Qualification, and Validation (CQV) concepts and activities employed in a modern biopharmaceutical manufacturing facility.

This course delivers theory covering CQV, Process Validation Lifecycle, and Validation Risk Analysis. The hands-on practical sessions compliment this theory with topics covering Commissioning, FAT/SAT, Installation Qualification (IQ), Operation Qualification (OQ), and Continuous Process Verification (CPV) at an introductory level.

Biomanufacturing Masterclass

Join BioHub Maryland for the biopharma skills masterclass designed to give trainees a detailed insight into the skills and knowledge needed to progress into a career in this exciting and expanding field. After this masterclass, participants will have gained knowledge and understanding of potential career paths and areas of interest for future focus and studies. Individuals will take part in lectures and hands-on practical sessions over a two-week period covering topics such as lab safety, documentation practices, contamination control, gowning for biologics operations, growth of cells, quality testing, and more.

Workshops with Industry Partners

BioHub Maryland will be collaborating to offer workshops with industry partners on specialized topics. These workshops will typically include lectures, lab tours, hands-on demonstrations of equipment use, and lunch with networking.