University of Wisconsin–Madison

Continuous Manufacturing – Select Lectures from the 2018 June Land O’ Lakes Conference

Developed & Conducted by the Division of Pharmacy Professional Development, School of Pharmacy, University of Wisconsin-Madison.

People attending a Pharmacy Conference

The 60th Annual Formulation Development and Drug Delivery Conference was held in Madison, Wisconsin on June 6-9, 2018.  The topic for 2018 was “Technical and Regulatory Considerations for Development and Commercialization of Drug Substance and Drug Product Continuous Manufacturing.” While it is impossible to capture the essence of the entire conference, these 3 lectures were selected to give you a snapshot of the meeting and useful information that you can apply to your own CM processes.

Registration Information

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Refund Policy

Register by: Jun 30, 2019
Course date:Aug 9, 2018 - Jun 30, 2019
Location:
Course fee:

$50 per individual lecture

or

$125 for series of 3

Course Objectives

Lecture 1: Introduction and Overview of Continuous Manufacturing by Johannes Khinast

Professor Johannes Khinast of the Graz University of Technology is one of the foremost experts on process and particle engineering especially in a continuous manufacturing setting. In this lecture Prof. Khinast provides a comprehensive overview of continuous manufacturing with special consideration for formulation development.

Lecture 2: Development and Control Strategy Considerations of Continuous Manufacture by Nick Falco

Nick Falco is an Engineering Manager and CMC Technical Leader at GlaxoSmithKline. There are significant benefits for switching drug API manufacturing from a batch to continuous process. Drawing from his experiences Nick outlines the basics of the transition and provides detailed information on control strategy considerations that drug manufacturers should keep in mind. 

Lecture 3: Regulatory Updates and Perspectives by William Kluttz

The final day of the June Land O’ Lakes Conferences focuses on regulatory perspectives that are critical for the pharmaceutical industry. This lecture series William Kluttz PhD,  a Senior Research Advisior at Eli Lilly & Co, provides a detailed overview of Regulatory Updates and Perspectives related to Continuous Manufacturing.

Course Outline

Lecture 1

Introduction and Overview of Continuous Manufacturing by Johannes Khinast

This presentation is designed to provide an introduction to biologics including: historical perspectives, current approaches to biotherapeutic product development, and an overview of the value chain of biologic drug development. Learners will gain an understanding of how the operational elements of biotechnology development and the interdependency of specialty skills are synchronized to maximize the probability of success.

Speaker: Johannes Khinast, PhD, Professor, Institute for Process and Particle Engineering and Director of Research Center Pharmaceutical Engineering, Graz, University of Technology, Graz Austria

Lecture 2

Development and Control Strategy Considerations of Continuous Manufacture

Since the Biologics Price Competition and Innovation Act (BPCIA) was signed into law in 2010 the US health system thus far has seen only a small number of biosimilar medications brought to the US market through the 351(K) approval pathway. Approvals included two (2) molecules in 2017 and two (2) additional molecules YTD in 2018. The expectation among both consumers and manufacturers has been that biosimilars will usher in a new era of competition and ultimately cost savings for the US Healthcare system. With four biosimilars currently available within the US market and up to seven additional innovators drugs under risk of biosimilars this lecture will explore the economics behind biosimilars and the implications for both pharmaceutical manufacturers and those responsible for paying for medications within the United States.

Predicting the actual cost savings has been difficult. We will explore whether the cost savings has met expectations of payers. The presentation will also cover unique aspects of cost modeling for biosimilars. Lastly, we will discuss what the future holds for manufacturers and consumers.

Speaker: Nick Falco, Engineering Manager and CMC Technical Leader, GlaxoSmithKline, King of Prussia, PA

Lecture 3

Regulatory Updates and Perspectives

This lecture focuses on the pharmacology, safety and preclinical PK of monoclonal antibodies and on how these data are integrated to propose a first dose in humans. To that effect, a/ the salient points of relevant guidelines will be reviewed; b/ the type and use of preclinical pharmacology data will be discussed and c/ a strategy to integrate preclinical PK data (Species, Dose, Disposition, Target compartment) as well as preclinical pharmacology and safety data to select a first dose will be described.

Speaker: William Kluttz, PhD, Senior Research Advisor, Global Regulatory CMC, Eli Lilly & Co.

Instructors

Nick Falco, Engineering Manager and CMC Technical Leader, GlaxoSmithKline, King of Prussia, PA

Johannes Khinast, PhD, Professor, Institute for Process and Particle Engineering and Director of Research Center Pharmaceutical Engineering, Graz, University of Technology, Graz Austria

William Kluttz, PhD, Senior Research Advisor, Global Regulatory CMC, Eli Lilly & Co.

Program Coordinator

Eric Buxton, PhD

Division of Pharmacy Professional Development
777 Highland Avenue
Madison, WI 53705
(608) 262-2431 FAX
(608) 265-2259
eric.buxton@wisc.edu