Manufacturing and QC of Biopharmaceutical Drugs
Duration : 60 Minutes
Barry Rosenblatt, PhD,
Dr. Rosenblatt is a subject matter expert in the chemistry and manufacturing controls (CMC) of bio-therapeutics, with a proven 36-plus year track record in biotechnology and the pharmaceutical industry. He developed, transfer Read more
The manufacture and release of a commercially approved biopharmaceutical drug under cGMP is a complex and expensive operation. The design and construction of a manufacturing plant to handle kilogram quantities of drug substance requires an in-depth understanding of the scale required to support the production, purification, and formulation, as well as the ancillary functions necessary to produce a product that meets the criteria of safety, purity, activity, and batch to batch consistency. This webinar will present a case example of a legacy manufacturing plant designed to deliver a metric ton of monoclonal antibody per annum.
Course Objectives:
• Seeing an example of a large scale manufacturing plant through a pictorial guided tour
• Understanding why the production of biologics is so expensive
• Why microbial control is so important
• In-process testing for a typical biologic
• Release testing for a typical biologic
Why Should You Attend:
An understanding of the complexities and costs associated with the design, manufacturing and release of a biopharmaceutical drug is essential to allow for process development, scale up, launch and commercialization.
Course Outline:
• Overview of development of a drug
• Guided tour through a large scale facility
• Facilities
o Utilities
o Maintenance
• QC/QC activies
o Batch records
o In-Process controls
o Product release testing and CoA
What You Get:
• Training Materials
• Live Q&A Session with our Expert
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points
Who Will Benefit:
• Process Development scientists
• Facility designers
• Manufacturing Personnel and Managers
• QC/QA
• CMC team leaders
Please reach us at 1-888-844-8963 for any further assistance or if you wish to register
