Aseptic Processing ofBiopharmaceuticals:Fill-Finish Technology andPatient-Friendly Devices

12 - 14 October | Korea Standard Time, GMT+9

VIRTUAL CONFERENCE

ASIA PACIFIC

11:00 – 11:10 Welcome & Introduction Richard Johnson, President, PDAMarcel Ewals, Executive Director, PDA Asia PacificJavier Camposano, Steering Committee Chair, Vice President - Head of the Global Drug Product Expansion Division, Celltrion Inc.

This Virtual Conference will give an update on the manufacturing of sterile products and patient-friendly application systems. The goal is to present the latest on new technologies in fill-finish operations with the upcoming GMP regulations (Annex 1) in mind. The conference will also include insights into market and technology trends for more patient-friendly injection systems.

11:10 – 12:40 Session 1: Keynote 1: Aseptic Manufacturing in Times of Covid-19: Supply Chain, People, ManagementThe keynote presentation will address how a risk-based fast development of a vaccine in a pandemic situation could look like. A discussion will address challenges the pharmaceutical industry is facing in this pandemic situation.Moderator: Georg Roessling, PhD, Senior Consultant, Business Development Asia, PDA

11:10 – 12:10 Covid-19 Panel Discussion:Equipment Suppliers and Primary Packaging Material Providers Response to Covid-19 Panelists: Tobias Goettler, Wenzel Novak, Cathy Zhao, Ashwini Bhisikar, Brett Marshall, Matthias Poslovski

Although there have been several vaccine candidates that have entered into Phase III efficacy trials, there remains a slew of considerations that need to be taken into account: What is the greater impact of an approved vaccine on the Pharmaceutical Industry from a supply perspective? How will this affect the launch of other products that are currently in development? And are we logistically prepared as a society to handle the sudden outbreak of another pandemic?

12:10 – 12:40 Implementing a New PFS Line with Isolator during Covid-19Yu Jung Yang, Assistant Manager- Global Drug Product Expansion Team, Celltrion Inc.

12:40 – 13:10 Session 2: Keynote 2: Regulatory This session summarizes the essential aspects of the upcoming GMP regulation on manufacturing of sterile products (Annex 1) and the new requirements and its implications on manufacturing. The document was developed by regulatory experts from European Medicine Agency (EMA) and PIC/S and commented by industry experts e.g. PDA and other organisations from around the world.

Therefore, it will be the global standard for manufacturing of injectables. A panel discussion will follow the keynote presentation which will be given by a European inspector.

Moderator: Georg Roessling, PhD, Senior Consultant, Business Development Asia, PDA

12:40 – 13:10 Regulatory Update: Annex 1 Rico Schulze, GMP Inspector, Saxon State Ministry for Social Affairs and Cohesion

13:10 – 13:25 l Sponsor Demonstration - Charles River Laboratories Korea

13:25 – 14:00 l Break

14:00 – 16:00 Session 3-1: Manufacturing: -Filling Lines and Barrier Systems

This session will give an overview of the current best practices for fill-finish operations of injectables. The presentations highlight the technical developments also including the latest regulatory requirements. Latest concepts will be presented on IPCs, ready-to-use systems, filling systems, digitalisation, data handling, process simulation, change over time reduction, defect avoidance, and barrier systems.

Moderator: Javier Camposano, Vice President - Head of the Global Drug Product Expansion Division, Celltrion Inc.

14:00 – 14:30 Trends in Filling Lines for Injectables Matthias Poslovski, Vice President Sales Turnkey, Optima Pharma GmbH

14:30 – 15:00 Process Reliability meets Zero RejectTobias Wetzel, Area Sales Manager, Bausch + Ströbel

15:30 – 16:00 Panel Discussion and Q&A

16:00 – 16:15 l Break

Aseptic Processing of Biopharmaceuticals:Fill-Finish Technology and Patient-Friendly DevicesMonday, 12. October | Virtual Conference - Korea Standard Time, GMT+9

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Aseptic Processing of Biopharmaceuticals:Fill-Finish Technology and Patient-Friendly DevicesMonday, 12. October | Virtual Conference - Korea Standard Time, GMT+9

16:15 – 18:15 S3-2: Manufacturing: - Smoke Studies and Sampling in Aseptic EnvironmentsProcess validation of injectables requires an aseptic process simulation (APS). This is to ensure that any interventions do not lead to product contamination. The session describes the regulatory requirements and how smoke studies can support APS. Case studies show how interventions and specifically sampling should be done in a way that mitigates contamination risk. An approach which is in compliance with the upcoming Annex 1.Moderator: Javier Camposano, Vice President - Head of the Global Drug Product Expansion Division, Celltrion Inc.

16:15 – 16:45 Characterization of Air Flow Patterns Morgan Polen, Contamination Control Expert, Microrite

16:45 – 17:15 APS Intervention and Smoke Study – A Case Study DeokSeok Oh, Manager in Technical Operations, Janssen Vaccines, South Korea.

17:15 – 17:45 Sampling in an Aseptic Process – Risk Mitigation & Regulatory ComplianceSomasundaram G., Senior Technical Consultant, APAC, Process Solutions, Merck KGaA

17:45 – 18:15 Panel Discussion and Q&A

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11:00 – 14:00 S3-3: Manufacturing: - Container IntegrityThe fill finish process has to ensure that the containers with the product are properly sealed. The The presentations in this session will describe and discuss the different approaches on how to verify correct container sealing. One of the presentations will also share a new concept of capping of vials, most suitable for freeze-dried products.Moderator: Georg Roessling, PhD, Senior Consultant, Business Development Asia, PDA

11:00 – 11:30 Headspace Applications for Container Closure Integrity (CCIT)Derek Duncan, Director of Product Line Europe, Lighthouse Instruments

11:30 – 12:00 Simulated Leaks for CCIT Positive Control: Differences Between Rigid Glass and Soft Plastic PackagingHenry Lu, Micromachining Manager, OpTek Systems’ Asia Pacific

12:00 – 12:30 l Break

12:30 – 13:00 Best practice CCIT in Manufacturing Oliver Stauffer, CEO, pti

13:00 – 13:30 Container Closure Integrity Evaluation for Sterile Product Packages Boo Jia Min, Technical Account Specialist, West Pharmaceuticals Singapore

13:30 – 14:00 Panel Discussion and Q&A

14:00 – 14:15 l Sponsor Demonstration – MERCK

14:15 – 14:30 l Break

14:30 – 16:30 S3-4: Manufacturing: - Filling SpecificsWhen selecting a filling system, the physical properties for the liquid like viscosity, foaming etc. have to be taken into account. This session gives an overview of current systems and trends. A case study of optimizing a time pressure filling system will be shown.

Moderator: Tan Chin Bin, Head of Technology Management, Asia Pacific, Merck

14:30 – 15:00 Filling Systems for Injectables- From Stainless Steel to A Single Use Filling PathTobias Goettler, Head of Product Management & Marketing – Product Group Pharma Liquid, Syntegon Technology GmbH

15:00 – 15:30 Time Pressure Filling (TPF) System Optimization - A Case Study Tobias Goettler, Head of Product Management & Marketing – Product Group Pharma Liquid, Syntegon Technology GmbHJungWoo Han, Senior Engineer, Janssen Vaccines, South Korea

15:30 – 16:00 Minimizing Contamination Risk In Single Use Final Filtration & FillingSomasundaram G., Senior Technical Consultant, APAC, Process Solutions, Merck KGaA

16:00 – 16:30 Panel Discussion and Q&A

16:30 – 16:45 l Break

16:45 – 18:45 S3-5: Manufacturing: - Visual InspectionAll injectable products have to be 100% visually inspected. This final step in the fill-finish operation is very important to detect any defects resulting from the manufacturing or the container components, therefore it is most important. This session presents approaches for manual and automatic inspection. How to make use of the Knapp test and how deep learning image processing can help to control large and small batches. A discussion with a regulatory inspector will end the session.

Moderator: DeokSeok Oh, Manager in Technical Operations, Janssen Vaccines, South Korea

16:45 – 17:15 Artificial Intelligence for Visual Inspection of Parenterals: Deep Learning image processing in Automated Inspection MachinesJose Zanardi, Senior Manager, Engineering Vision, Syntegon Technology K.K.

17:15 – 17:45 Visual Inspection: Establishment of Manual and Automatic Knapp Set DataUwe Schaefer, Area Sales Manager, Seidenader Maschinenbau GmbH

17:45 – 18:15 Regulatory Perspective on Inspection of Injectable Products for Visible ParticulatesSheena Wang, Senior CMC Reviewer, ONDP, U.S. FDA l Center for Drug Evaluation and Research (CDER)

18:15 – 18:45 Panel Discussion and Q&A

Aseptic Processing of Biopharmaceuticals:Fill-Finish Technology and Patient-Friendly DevicesTuesday, 13. October | Virtual Conference - Korea Standard Time, GMT+9

Aseptic Processing of Biopharmaceuticals:Fill-Finish Technology and Patient-Friendly DevicesWednesday, 14. October | Virtual Conference - Korea Standard Time, GMT+9

11:00 – 11:30 S4-2: Container Integrity at Deep Freeze TemperaturesAn increasing number of pharmaceutical products are injectables. In order to improve convenience for patient in home care situations and medical personnel there is a strong trend for the use of pre-filled syringes and increasingly also devices like pens, autoinjectors and wearables. The session will give an overview of the market trends of patient-friendly injection systems and several presentations show technical solutions. A case study will share practical aspects of the development of an autoinjector based product.Moderator: Georg Roessling, PhD, Senior Consultant, Business Development Asia, PDA

11:00 – 11:30 The Contribution of Rubber Adhesion to Sealability at Deep Freeze TemperaturesCathy Zhao, Director of Scientific Insights Lab, West Pharmaceutical Services, Inc.

11:30 – 13:45 S4-1: Container Closure ComponentsThe right selection of container closure components e.g. glass or polymer primary packaging, elastomer and capping system is an important part of the development of injectable products. The selections need to consider interactions of the formulation with the container components but also the machinability/handling in the fill finish process. The session will share details on the selection of the glass container, ready-to-use elastomers, and processing of stoppers. A special case of stoppers for cryogenic stored products will be discussed.Moderator: Georg Roessling, PhD, Senior Consultant, Business Development Asia, PDA

11:30 – 12:00 Integrated Development Approach: From Glass Science to Glass Primary Container Selection Serena Panighello, Senior Scientist, SG Lab Analytics

12:00 – 12:30 RTU Elastomeric Products and State-Of-The-Art Manufacturing Environments for Such StoppersAshwini Bhisikar, Technical Key Account Manager, Datwyler Pharma Packaging India Pvt Ltd

12:30 – 13:00 Elastomer Handling in Aseptic Processing: Washing Siliconization, SterilizationJana-Cathrien Müller, Sales Manager, Atec Pharmatechnik GmbH

13:00 – 13:30 | Panel Discussion and Q&A 13:30 – 13:45 l Sponsor Demonstration - West Pharmaceutical Services

13:45 – 14:15 l Break

14:15 – 14:45 S5-1: Market TrendsModerator: Tae-soo Lee, Director of Drug Product Department, Samsung Bioepis

14:15 – 14:45 Patient-Friendly Injection Systems, Market Trends & DevelopmentsBrigitte Reutter-Haerle, Vice President Product Management & Marketing, Vetter Pharma International GmbH

14:45 – 17:45 S5-2: Safety Syringes, Autoinjectors, Pens and WearablesModerator: Tae-soo Lee, Director of Drug Product Department, Samsung Bioepis

14:45 – 15:15 Safety Syringe in Ready-To-Fill ConfigurationWenzel Novak, Global Senior Director Business Development MDS, Gerresheimer Bünde GmbH

15:15 – 15:45 Development Progress of Autoinjector and Its Usability Feedback - Importance of Container/Closure Integrity in AutoinjectorMinuk Kim, Principal Scientist, DP Group, Samsung Bioepis

15:45 – 16:00 l Break

16:00 – 16:30 Trends in the Self-injection Device Market & Next Generation Platform Technologies Yves Grossenbacher, Business Development Manager, Ypsomed AG

16:30 – 17:00 The “Customizable Platform” Paradox: A Flexible Design and Development Model for Platform Devices Lyndon Wild, Senior Director Commercial Operation, SHL Medical AG

17:00 – 17:15 Manufacturing Line for Wearable Devices - A Case Study for an Insulin ProductChristian Kollecker, Sales Director Aseptic Technology, Höfliger

17:15 – 17:45 | Panel Discussion and Q&A

17:45 Closing Remarks Georg Roessling, Senior Consultant, Business Development Asia, PDA

JAVIER CAMPOSANO (CONFERENCE CHAIR)Javier Camposano serves as the Vice President - Head of the Global Drug Product Expansion Division at Celltrion Inc. Previously, Mr. Camposano worked for Baxter in a variety of Fill and Finish Engineering and Management positions leading Aseptic Filling CAPEX, technology transfers, commercial development projects and supervising cross functional functions.

After joining Celltrion in 2011 he co-led a new Drug Product Division to fill and finish Biosimilar products. He was responsible for the alignment, development and establishment of Celltrion's DP manufacturing standards, procedures, in compliance to international regulatory requirements.

In 2013 and 2016 Celltrion's first mAb Biosimilar Remsima, was respectively approved by the EMA and the US FDA for commercial market distribution, first in the world. In 2014 Mr. Camposano assumed the leadership of the DP Division becoming responsible for the DP global commercial manufacturing operations. In 2017 Mr. Camposano begun overseeing the expansion of the division into PFS applications including Auto injectors and in December 2018 the GDPE division was created to expand Celltrion's manu-facturing operations overseas.

As head of this division Mr. Camposano is responsible for the evaluation and selection of future Celltrion DP manufacturing facilities. Mr. Camposano holds a BS in Mechanical Engineering from the University of California at Davis and a MBA from Pepperdine University - California.

DEOKSEOK OHDeokSeok is a manager of aseptic & sterilization team in Technical Operations department at Janssen Vaccines Incheon site and is responsible for aseptic processing and New Product Introduction supporting. DeokSeok has about 15 years experience in Quality & Aseptic area and diverse experiences in project which are plant construction project, new-line project and overseas project before joining in J&J. DeokSeok has also diverse inspection experiences including Korean (MFDS), UK (MHRA) and WHO.

DeokSeok has been a PDA member since 2007.

STEERING COMMITTEE

MIN HONGJIN(CHARLES RIVER LABORATORIES)Hongjin Min has been working with Charles River since 1996 in various roles such as a Sales and Marketing Manager and an Asia Pacific Technical Manager. Today however, he oversees the sales organization of Charles River Microbial Solutions in Asia Pacific as the Sr. AP Managing Director. Hongjin Min is well acknowledged in the field as an expert and a specialist in successful technical education, training, and in some R&D involvement including international endotoxin standard harmonization work across Asia Pacific. Given his credentials, Hongjin Min has also given multiple endotoxin testing lectures in the region and was involved in government projects as well.

Hongjin Min received his B.S. and M.Sc. from Seoul National University, and finished his Ph.D program in Bio Regulatory Science at Korea University.

STEERING COMMITTEE

TAESOO LEE(SAMSUNG BIOEPIS)Tae-soo Lee is working as director of Drug Product department in Samsung Bioepis. He joined Samsung Bioepis since 2008, and his specialties are development and tech. transfer regarding Purification, Formulation, Fill/Finish and Combination product.

Recently, he was deeply involved in the development and approval from EMA and FDA for the combination products of pre-filled syringe and autoinjector, such as Enbrel biosimilar and Humira biosimilar.almost 30 years and he received the PDA Honorary Membership.

STEERING COMMITTEE

DR. GEORG ROESSLING (PDA)Georg Roessling has been a consultant since 2017. From 2006-2017 he held the position of Sr. Vice President of PDA Europe, where he started the office in Europe and developed a number of conferences and training courses together with regulatory agencies, pharmaceutical industry and suppliers. Before that he worked from 1984-2005 with Schering AG in various positions. These roles included head of pharmaceutical devlopment of parenterals and head of Global CMC Technology office.

Georg is a chemist by training, has a PhD in Physical chemistry from the university of Karlsruhe and was a post-doc in Chemical Engineering in Berkeley, USA. He has been a PDA member for almost 30 years and he received the PDA Honorary Membership.

2020 PDA APAC KOREA SPONSORSPLATINUM SPONSORS

Company Name:CHARLES RIVER LABORATORIES KOREA

Charles River Microbial Solutions portfolio of Endosafe® endotoxin testing, Celsis® rapid microbial detection, and Accugenix® microbial identification and strain typing products and services facilitate confident and objective decision making, ensuring the integrity of your microbial data and minimizing the risk to your patients.

Company Website: www.criver.co.kr

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2020 PDA APAC KOREA SPONSORSPLATINUM SPONSORS

Company Name:JANSSEN | JOHNSON & JOHNSON

At Janssen, our fight against infectious diseases is a global effort. From viral hepatitis and human immunodeficiency virus (HIV) to pathogens of global concern. We strive to discover and develop novel therapeutics and vaccines to help prevent, treat, and ultimately cure infectious diseases worldwide, improving treatment outcomes and patients’ lives.

Company Website: www.janssen.com/

Company Name:MERCK

Merck, a life science leader, is a business of Merck KGaA, Darmstadt, Germany. Our comprehensive portfolio supports customers during all stages of the drug manufacturing process. With our broad range of products, applications and services including single-use manufacturing, filtration, chromatography and purification, virus reduction, pharma and biopharma raw materials, drug delivery compounds, and engineering and validation services we are committed to best support your goals of intensified, connected or continuous bioprocessing. Our industry expertise and regulatory know-how help you get to clinic faster, allowing you to focus on what matters most — delivering safe, effective therapies sooner to the patients that need them most.

Company Website: www.merckmillipore.com

2020 PDA APAC KOREA SPONSORSPLATINUM SPONSORS

© 2020 Merck KGaA, Darmstadt, Germany and/or its affiliates. All Rights Reserved. Merck, the vibrant M, Millipore, and NovaSeptum are trademarks of Merck KGaA, Darmstadt, Germany or its affiliates. All other trademarks are the property of their respective owners. Detailed information on trademarks is available via publicly accessible resources.

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MK_AD6566ENPDA Korea 32855 10/2020

Company Name:WEST PHARMACEUTICAL SERVICES

West Pharmaceutical Services, Inc. is a leading manufacturer of packaging components and deliv-ery systems for injectable drugs and healthcare products. Working by the side of its customers from concept to patient, West creates products that promote the efficiency, reliability and safety of the world's pharmaceutical drug supply. West is headquartered in Exton, Pennsylvania, and supports its customers from locations in North and South America, Europe, Asia and Australia. West's 2019 net sales of $1.84 billion reflect the daily use of approximately 100 million of its com-ponents and devices, which are designed to improve the delivery of healthcare to patients around the world.

Company Website: www.westpharma.com

2020 PDA APAC KOREA SPONSORSPLATINUM SPONSORS

For more information, contact West today. www.westpharma.com

FluroTec Film May Help to: Improve compatibility between the elastomeric

closure and the drug

Provide lubricity without the need for free silicone oil when used in combination with B2-coating

Ensure predicatable break loose and extrusion forces in syringe systems

Reduce stopper clumping incidents during autoclave sterilization

Prevent stoppered vials sticking to shelves in lyo chambers

Enhance Component Compatibility and Improve PerformanceWest FluroTec® barrier �lm helps protect drugs by providing a barrier that minimizes interaction between the drug and the closure while maintaining container closure integrity. In addition, the �uoropolymer �lm reduces absorption and adsorption of the drug product, an important bene�t for maintaining the strength and shelf life of most drugs.

North America 1-800-345-9800 option 8 | South America +55 11 4055 6061 | Europe +49 (0) 2403-7960 | Asia Paci�c +65 6862 3400

West and the diamond logo, and FluroTec® are registered trademarks of West Pharmaceutical Services, Inc. in the United States and other jurisdictions. FluroTech technology is licensed from Daikyo Seiko Ltd. Copyright © 2020 West Pharmaceutical Services, Inc. #10313 0617

Company Name:OPTEK SYSTEMS

Headquartered in the UK, OpTek Systems is a specialist in precision micromachining. In the field of Container Closure Integrity Testing (CCIT), OpTek specializes in the provision of simulated leaks used as positive controls during process validation and qualification. Services include laser drilling and capillary processing, the provision of orifice plates, wires, micropipettes, and optical and flow-based measurement and CoC reporting..

Company Website: www.opteksystems.com

2020 PDA APAC KOREA SPONSORSEVENT TRACK SPONSOR

Company Name:VETTER PHARMA INTERNATIONAL GMBH

Vetter is a global leading CDMO, headquartered in Ravensburg, Germany, with production facilities in Germany and the United States. The company has long-term experience in supporting biotechnology and pharmaceutical customers both large and small. Vetter services range from early-stage development support including clinical manufacturing to commercial supply and numerous packaging solutions for vials, syringes, and cartridges.

Company Website: ow.ly/mhwq50bwnoa

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