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Agenda
Agenda
Overview
Downstream process applications in biopharmaceutical processing include a variety of key separations technologies. Through technological innovations, bioprocessing experts anticipate significant improvements in the productivity and efficiency of these downstream processes.
Description
This Course will provide an insight and overview into the fundamentals of Downstream Processing for the biopharmaceutical product recovery operations, e.g., tangential / crossflow (TFF /CFF) filtration through final filling. With an emphasis on traditional downstream purifications processes, attendees will be provided an understanding of both theoretical and practical application of these technologies as well as the protocols and rationales for operational optimization and process scaling. We will explore new and emerging purification technologies such as membrane chromatography and robust virus clearance technologies and applications. Primary focus is on high purity recombinant protein production, applicable smaller molecular purification and scaling up / down are covered topics with issues of validation, regulatory requirements and industry standards.
Rationale
Attendees will learn the latest developments in Downstream Processing products and applications. ‘How-to' apply these technologies to their projects and process operations will be provided by practical applications.
Who Should Attend
Process Development Engineers and Scientists, R&D Personnel, Pilot-Plant Operations, Protein Purification Staff, and QA/RA.
Prerequisites
An understanding of process development, improvements, and scaling will enhance the learning experience of this Course. It is designed for the experienced as well as those new to biopharmaceutical processes.
Learning Objectives
At the completion of this workshop the participant will be able to:
• Define principle parameters governing downstream processes
• Be able to make informed decisions in process optimization.
• Design experiments that reflect large scale optimization / yields.
• Understand regulatory requirements and industry qualification standards.
• Identify relevant applications for membrane chromatography application.
• Understand virus clearance studies to meet requirements.
• Understand the latest trends in DS Single-use disposables technologies.
KEY TOPICS: Main lecture topics and workshop program;
• DS Separation and Purification Processes with practical applications.
• Product separation / clarification and purification processes.
• Use of TFF and membranes for DNA, HCP, viral protein removal.
• Methods for performing viral clearance studies.
Program Schedule
This course begin at 1:30 p.m. and end at 5:00 p.m. on the first day and Starts at 8:00 a.m. and ends at 5:00 P.m. on second day.
Please arrive at your course location approximately thirty minutes before the start of the course to register and receive your course materials. Please be sure to bring your confirmation letter as proof of registration during check-in. You will not be able to attend a course without payment, or guarantee of payment.
A continental breakfast will be served before class beginning 7:30 a.m. Lunch will be provided from 12:30 - 1:30 p.m. Snacks will be provided during the morning break from 10:00 - 10:30 a.m. and the afternoon break from 3:00 - 3:30 p.m.
Presenters
A. Mark Trotter, M.Sc., M.B.A
President and Principal Consultant
Trotter Biotech Solutions
Mr. Trotter, with over twenty years experience in the pharmaceutical and life science industries, has a broad range of work experience, from Pharmacologic chemistry R&D project leader in academia to Marketing Management with laboratory & process equipment manufacturers. He presents technical papers, workshops, seminars and training courses relating to biopharmaceutical topics from membrane filtration, Single-Use disposables, utilities, upstream & downstream processing, polymer leachables and extractables, validation, qualification and regulatory/industry requirements and trends. He publishes technical articles, book chapters and contributed expert comment on these subjects. A member of PDA, ASM American Society of Microbiology, SBE Society for Biologic Engineering, American Society of Quality and ISPE.
Michael Dosmar
Product Manager
Sartorius-Stedim Biotech
He is Product Manager at Sartorius-Stedim Biotech in the Purification Technologies group.
The Sartorius Group is a leading international laboratory and process technology provider covering the segments of biotechnology and mechatronics. The major areas of activity in its biotechnology segment focus on fermentation, filtration, fluid management, purification and laboratory applications.
Mr. Dosmar received his BS from Indiana University and MS from University of Illinois. Mr. Dosmar has broad based expertise in the application development and implementation of filtration technologies as well as the design of laboratory & process scale Micro and Ultrafiltration systems. Having served the biotechnology industry for more than 30 years, he is a frequent speaker, teacher, and workshop leader on the use, application, scale-up, performance optimization and design of filtration equipment in biotechnology processes. He has authored numerous articles and book chapters on a variety of subjects related to filtration as well as serving on the faculty of a number of industry specific courses, seminars and committees.
Registration Fee
Up to and on December 31: $950
On and after January 1: $1250
Government/Academia: 20% discount off above pricing
Group rate: available upon request
Register for both Courses (Downstream Processing & Biosystems Fundamentals at the same time for $1700 until December 31st and $2200 on & After January 1. You must fill out the registration form in the brochure and email or fax it. |
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