Content

BEC 485/585
cGMP Downstream Operations

Course Description

This course focuses on the downstream processing steps used for the manufacture of biological products. Biological products, also referred to as biopharmaceuticals, are a class of extremely effective, life-changing medicines used for the prevention and treatment of a range of diseases. Therapeutic proteins are among the biggest selling biopharmaceuticals and are typically produced by genetically engineered cells. Processes to produce, recover, purify, and formulate these therapeutic proteins require numerous and (sometimes) complex steps.

In BEC 485/585, you will transfer/scale up the downstream processing steps developed in BEC 436/536 for production of green fluorescent protein - our model biopharmaceutical - to BTEC's manufacturing area. You will execute those steps using industry-relevant manufacturing equipment while adhering to current Good Manufacturing Practice (cGMP) regulations.

BEC 485/585 consists of both lectures and lab exercises. Lectures are focused on (i) production-scale equipment used for major downstream operations, such as homogenization, centrifugation, chromatography, and tangential flow filtration; (ii) ancillary downstream processing operations such as equipment cleaning/sanitization, solution prep, and filter integrity testing; (iii) facilities used in biopharmaceutical production; and (iv) cGMP topics such as documentation, deviations, and process validation. Lab exercises build on lecture topics by having students execute the major and ancillary operations required for the production of green fluorescent protein in a simulated cGMP manufacturing environment.

Learning Outcomes

At the end of this course, students will be able to:

• Explain why and how biopharmaceutical production is regulated and the key concepts involved.
• Describe basic considerations in designing a facility for DS cGMP manufacturing.
• Describe equipment used for DS biopharmaceutical production, both for the main process and in supporting operations, including its purpose and important features; set up and operate equipment.
•  Extend process design concepts from BEC 436/536 to transfer BTEC’s model DS GFP process to manufacturing scale.
• Analyze DS process failures to determine root cause and recommend CAPAs.
• Assess whether processes are capable of meeting criteria that ensure product quality.
• Describe QC testing for DS cGMP biomanufacturing operations.

Prerequisites

BEC 436 or BEC 536

Text Requirements

Students will be required to purchase a course pack, which includes lecture materials and laboratory modules.