Content

Hands-On Single-Use Processing for Biopharmaceuticals

• Registration is unavailable at this time.

Delivery methods

	50% Lecture
	50% Hands-on lab experience

Course content

	20% Fundamentals and concepts
	40% Industry applications
	40% Emerging technologies

Upstream

Downstream

This course can count toward your Professional Certificate in Biomanufacturing Science.

Why should you attend?

This course will provide hands-on training in a single-use biomanufacturing process using mammalian cell culture and the latest technologies spanning upstream and downstream operations. Participants will gain laboratory experience in media and solution preparation using single-use mixing systems, cell culture in single-use systems (single-use bioreactors in rocker, stirred-tank, and fixed-bed configurations), cell growth in fed-batch and perfusion modes, cell harvest by single-use depth filtration, purification by single-use chromatography, as well as other downstream operations. In addition to extensive hands-on experience with the process, the course will also address many of the common concerns when implementing single-use processes (i.e., sterile connections, leachables and extractables, environmental impact, and process economics).

Attend and you will learn

• Setup and operation of single-use options for both upstream and downstream processing steps;
• Advantages and disadvantages of single-use technologies relative to multi-use equipment;
• Process scenarios in which single-use technologies offer advantages over traditional multi-use equipment;
• Current technical limitations to single-use technology and how these limitations might impact your process design;
• Basic cost calculations to compare single-use options to more traditional multi-use set ups, to provide justification for single-use technologies;
• Validation expectations important to single-use systems, including testing of extractables and leachables.

Who should attend

The course covers material that is relevant to anyone in the biopharmaceutical manufacturing industry involved in the implementation of single-use technologies. Individuals that should consider attending:

• Scientists and engineers (BS, MS, PhD, or equivalent experience) working in upstream and downstream biopharmaceutical process development and manufacturing science
• Manufacturing managers interested in knowing more about how the processes in their suites are designed
• Process validation staff and quality assurance professionals
• Suppliers of components and contractors providing services to companies using single-use technologies

Attend and you will receive

• 22.5 hours of instruction (2.25 Continuing Education Units)
• Notebook containing all course lecture and lab materials
• Morning coffee and tea
• Lunch
• Afternoon beverage break
• Certificate of completion

Instructors

• Gary Gilleskie, Ph.D.
• Laurie Overton

Fee

$3,875

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