Single Use Technology in Sterile Manufacture

PRESENTERS

Recently named a 2015 Top 20 Under 40 Award Winner by ENR Mid-Atlantic,
Matthew Kennedy is a Bioprocess Specialist whose designs have been on the
cutting-edge of technology and have helped to establish him as an industry
expert with specialized knowledge in closed processing, single-use technology
flexible manufacturing, and continuous processing. His facility and equipment
design experience spans the breadth of the iotechnology industry with applications
in monoclonal antibody, vaccine and blood fractionation manufacturing facilities.

Matthew has almost 20 years of facility design experience exclusively in the
biotechnology industry and has held a leading role on several ISPE facility
of the year award winning projects (BioCork 2009, Shire HGT 2011).
He is an active biotech industry member, belonging to groups like the
International Society for Pharmaceutical Engineering (ISPE) and Biotechnology
Industry Organization (BIO). Matthew has been published in Pharmaceutical
Engineering Magazine and has been a regular presenter at Interphex and the
ISPE Annual Meeting.

Mark McElligott is the Founder of PDS Sandbox, as well as Partner
and Principal SU Engineer with PDS Consulting which are companies providing
Single Use technical engineering, QbD/QRM, process/product
development/design solutions for Single Use Technology (SUT)
end users and suppliers alike.

Mr. McElligott has 19+ years of experience in the biopharmaceutical,
medical device and pharmaceutical industries and his consulting expertise
is focused on SUT engineering for cGMP Manufacturing Operations,
SUT Implementation feasibility assessments, Leachables and Extractables
Program Development, Material Science Evaluations, Process Optimization/
Debottlenecking QbD/QRM and Product/Process Development.
Mark has developed and deployed defendable life-cycle based SUT
programs across the globe by working with end-users and suppliers
to establish appropriate and relevant requirements supporting patient
safety and product quality.

A Representative from the TGA Office of Manufacturing Quality will provide a presentation

highlighting trends in observations and issues they have observed

during inspections of GMP regulated manufacturers of sterile medicines both

in Australia and overseas. TGA will also participate in a facilitated

panel discussion with the presenters on topics of interest from delegates at the event.

EVENT DETAILS

This course will cover essential knowledge, best practice and emerging trends in the design, operation and validation of single-use systems utilised for manufacture of sterile products by aseptic methods. The material will cover facility engineering and process considerations, incorporating aspects of quality risk management and validation.

Our presenters are internationally recognized as experts in this area. They have extensive experience and their insights and opinions will present attendees with an opportunity to learn first-hand what it really takes to make aseptic process effective and fully compliant with regulatory expectation.

The material presented will provide insight into how regulators and industry are thinking about and approaching aseptic manufacture in the UK and US markets and provide commentary on emerging trends. The presentation style will permit interaction and discussion with the subject matter experts and others present.

It is recommended that participants should be familiar with basic concepts of sterile manufacturing facilities and operations prior to attending this course.

Who should Attend?
• Quality and validation practitioners, engineers, managers and staff involved in the manufacture of sterile medicinal products
• Technical professionals, management, vendors and operations personnel who support sterile manufacturing operations

Take Back to Your Job

Understanding of best practice for sterile manufacture and expectations incl. emerging regulatory views in US & EU
An overview of essential factors underpinning successful sterile manufacturing facilities and operations
An update on current developments in sterile manufacturing generally (incl. recent ISPE and PDA work in this area)
Understanding of current regulatory focus and concerns of the TGA

AGENDA

Monday

8:45am – 9:00am	Registration/Coffee
9:00am	Welcome, Introduction and program overview
9:15am – 10:00am	Session 1, Matthew Kennedy – Overview of Applications • Biopharm Unit Operations • Mixing • Heat Transfer • Fluid Transfer • Scale of Operation Drivers for Implementation • Speed to Market • Flexibility • Low Barrier to Entry • Scaling Out not Up
10:00am – 10:30am	Session 2, Mark McElligott – Single Use Technology Market Survey – Part 1 • Bags / Films • Tubing / Tubesets • Aseptic Connection Devices • Valves • Instrumentation • Pumps • Single Use Mixers
10:30 - 10:45am	Break
10:45 – 11:30am	Session 3, Mark McElligott – Single Use Technology Market Survey – Part 2 • Single Use Bioreactors • Harvest / Recovery • Chromatography • Tangential Flow Filtration • Virus Filtration • Final Filling / Freeze Thaw
11:30am - 12:00pm	Session 4, Matthew Kennedy – Economic Evaluation • Capital Cost • Operating Cost • Total Cost of Ownership
12:00pm	Lunch– Sponsored by
1:00pm – 2:00pm	Session 5, Mark McElligott – Uncovering the hidden costs of Single Use Technology Implementation • Associated Business, Technical and Quality realized costs Impacts to the Organization • Process Development • Supply Chain • Warehouse / Logistics / Waste Management • Validation / Change Control • Quality Assurance
2:00pm - 3:00pm	Session 6, Mark McElligott – New Challenges and Failure Modes through SUT implementation • Need for better understanding of CPPs/CQAs, etc • Visibility of bag contents and tubing raises new questions • System Integrity and Testing Needs/Challenges and Risk Reduction • QC and MFG SU Component/Part Inspection • What is a failure? A crease? A pit? A black spec or visible particulate? Best Practices for Handling and Inspection of Single Use Technology
3:00pm - 3:15pm	Break
3:15pm – 4:15pm	Session 7, Matthew Kennedy – What not to do….! • Technology Limitations • Tubing Management • Instrumentation Accuracy • Automation • Equipment Layout Challenges
4:15pm – 4:30pm	Wrap-up, questions and discussion
4:30pm – 5:30pm	Networking drinks and Canapés

Tuesday

8:00am – 8:30am	Registration and coffee
8:30am – 8:45am	Agenda Overview
8:45am – 9:30am	Session 8, Matthew Kennedy – Process closure • Case Study for Process Closure Analysis • Risk Assessment • Downstream Controls • Impacts to Environmental Classification
9:30am – 10:15am	Session 9, Matthew Kennedy – Industry Technology Trends • Cell Culture Amplification with ATF Technology • Acoustic Cell Separation • Multi-column Chromatography • Single Pass Tangential Flow Filtration
10:15am	Break
10:30am – 11:15am	Session 10, Mark McElligott & Matthew Kennedy - Facility considerations for SUT implementation: • Just-in-Time Warehousing • QC Inspection • Storage Conditions • Disposing of the Disposables • Materials Handling • Filter Holders, Pump Carts, tubing trays, etc for consistency of installation initiatives • Tubing Pass Thrus • Ergonomics • RMNCMR (Raw Material Non-Conforming Material Requests) • Holding/testing/disposition
11:15am – 12:00pm	Session 11, Matthew Kennedy – Designing the Facility of the Future • Review of a Next Generation Monoclonal Antibody Facility based on continuous, closed single use processing
12:00pm	Lunch – Sponsored by
1:00pm – 1:45pm	Session 12, Mark McElligott – Industry Guidance – Requirements and the Testing Relevance • USP Class VI vs USP 88 and ISO 10993 Parts 6, 10 and 11 • USP 87 • USP 85 • USP 788 • ADCF • Extractables and Leachables • ASTM and EP alignment
1:45pm – 2:30pm	Session 13, Mark McElligott – Defending SUT implementation during an agency inspection • Quality System Implementation: • SUT URS Guidelines • Quality SUT DR/RA • SUT Subcomponent classification • E&L program • Technical Quality Agreements • Vendor Auditing
2:30pm	Break
2:45pm – 3:30pm	Session 14, Mark McElligott - Life Cycle Approach to Single Use Implementation through effective Quality Risk Management – TGA perspectives
3:30pm – 4:30pm	Session 15, TGA: - TGA perspectives
4:30pm – 4:45pm	Wrap up, questions and conclusion

NB: Schedule times may be varied during the course with the agreement of delegates to ensure content is adequately covered.

Single Use Technology in Sterile Manufacture

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Single Use Technology in Sterile Manufacture

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