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- Welcome & Introduction | Korea Standard Time, GMT +9
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.
Richard Johnson, President, PDA
Marcel Ewals, Executive Director, PDA Asia Pacific
Javier Camposano, Steering Committee Chair, Vice President - Head of the Global Drug Product Expansion Division, Celltrion Inc. - Keynote 1: Aseptic Manufacturing in Times of Covid-19: Supply Chain, People, Management
Ashwini Bhisikar•Tobias Goettler•Brett Marshall•Wenzel Novak•Matthias Poslovski•Yu-Jung Yang•Cathy ZhaoThe keynote presentation will address how a risk-based fast development of a vaccine in a pandemic situation could look like. A discussion will address the 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-19
Yu Jung Yang, Assistant Manager - Global Drug Product Expansion Team, Celltrion Inc.
Ashwini Bhisikar
Technical Key Account Manager., Datwyler Pharma Packaging
Tobias Goettler
Head of Product Management & Marketing - Product Group Pharma Liquid, Syntegon Technology GmbH
Brett Marshall
Head of Quality Assurance, Zuellig Pharma
Wenzel Novak
Glob. Sen. Director Business Development MDS, Gerresheimer Bünde GmbH
Matthias Poslovski
Technical Sales Director, Optima pharma GmbH
Yu-Jung Yang
Assistant Manager - Global Drug Product Expansion, Celltrion Inc.
Cathy Zhao
Director of Scientific Insights Lab, West Pharmaceutical Services, Inc.
- Keynote 2: Regulatory
Rico SchulzeThis 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
Rico Schulze
GMP Inspector, Office of the Stateminister of Saxony, Germany
- Sponsor Demonstration: Charles River Laboratories Korea
- Break
- Manufacturing: Filling Lines and Barrier Systems
Richard Denk•Matthias Poslovski•Tobias WetzelThis 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. The latest concepts will be presented on IPCs, ready-to-use systems, filling systems, digitalization, data handling, process simulation, change overtime 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 Reject
Tobias Wetzel, Area Sales Manager, Bausch + Ströbel
15:00 – 15:30
Draft Annex 1 Requirements for Barrier Systems like Isolators
Richard Denk, Senior Consultant Aseptic Processing & Containment, SKAN AG
15:30 – 16:00
Panel Discussion and Q&A
Richard Denk
Senior Consultant Aseptic Processing & Containment, Skan AGMatthias Poslovski
Technical Sales Director, Optima pharma GmbH
Tobias Wetzel
Area Sales Manager, Bausch + Ströbel
- Break
- Manufacturing: Smoke Studies and Sampling in Aseptic Environments
Somasundaram G.•DeokSeok Oh•Morgan PolenProcess 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 Compliance
Somasundaram G., Senior Technical Consultant, APAC, Process Solutions, Merck KGaA
17:45 – 18:15
Panel Discussion and Q&A
Somasundaram G.
Senior Technical Consultant, APAC, Merck KGaA
DeokSeok Oh
Manager in Technical Operations, Janssen, Johnson & Johnson
Morgan Polen
Contamination Control Expert, Microrite
- Manufacturing: Container Integrity | KOREA STANDARD TIME, GMT+9
Jia Min Boo•Derek Duncan•Henry Lu•Oliver StaufferThe fill-finish process has to ensure that the containers with the product are properly sealed. The presentations in the 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 Packaging
Henry Lu, Micromachining Manager, OpTek Systems’ Asia Pacific
12:00 – 12:30 | 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
Jia Min Boo
Technical Account Specialist, West Pharmaceuticals
Derek Duncan
Director of Product Line Europe, Lighthouse Instruments
Henry Lu
Manager, OpTek Limited
Oliver Stauffer
CEO, PTI - Packaging Technologies & Inspection
- Sponsor Demonstration: MERCK
- Break
- Manufacturing: Filling Specifics
Somasundaram G.•Tobias Goettler•JungWoo HanWhen 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 Path
Tobias 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 GmbH
JungWoo Han, Senior Engineer, Janssen Vaccines, South Korea
15:30 – 16:00
Minimizing Contamination Risk In Single Use Final Filtration & Filling
Somasundaram G., Senior Technical Consultant, APAC, Process Solutions, Merck KGaA
16:00 – 16:30
Panel Discussion and Q&ASomasundaram G.
Senior Technical Consultant, APAC, Merck KGaATobias Goettler
Head of Product Management & Marketing - Product Group Pharma Liquid, Syntegon Technology GmbH
JungWoo Han
Senior Engineer, Janssen Vaccines, South Korea
- Break
- Manufacturing: Visual Inspection
Sheena Wang•Jose Zanardi•Christian SchererAll 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 Machines
Jose Zanardi, Senior Manager, Engineering Vision, Syntegon Technology K.K.
17:15 – 17:45
Visual Inspection: Establishment of Manual and Automatic Knapp Set Data
Christian Scherer, Executive Vice President - Sales/Business Unit Inspection Machines, Seidenader Maschinenbau GmbH
17:45 – 18:15
Regulatory Perspective on Inspection of Injectable Products for Visible Particulates
Sheena 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
Sheena Wang
Senior CMC Reviewer, Office of New Drug Products (ONDP), U.S. FDA | Center for Drug Evaluation & Research (CDER)
Jose Zanardi
Senior Manager, Engineering Vision Technology, Syntegon Technology K.K.
Christian Scherer
Executive Vice President – Sales / Business Unit Inspection Machines, Seidenader Maschinenbau GmbH
- Container Integrity at Deep Freeze Temperatures
Cathy Zhao11:00 – 11:30
An increasing number of pharmaceutical products are injectables. In order to improve convenience for the 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
The Contribution of Rubber Adhesion to Sealability at Deep Freeze Temperatures
Cathy Zhao, Director of Scientific Insights Lab, West Pharmaceutical Services, Inc.Cathy Zhao
Director of Scientific Insights Lab, West Pharmaceutical Services, Inc.
- Container Closure Components
Ashwini Bhisikar•Jana-Cathrien Müller•Serena Panighello•Cathy ZhaoThe 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 the processing of stoppers. A special case of stoppers for cryogenically 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,
Stevanato Group S.p.A.
12:00 – 12:30
RTU Elastomeric Products and State-Of-The-Art Manufacturing Environments for Such Stoppers
Ashwini Bhisikar, Technical Key Account Manager, Datwyler Pharma Packaging India Pvt Ltd
12:30 – 13:00
Elastomer Handling in Aseptic Processing: Washing Siliconization, Sterilization
Jana-Cathrien Müller, Sales Manager, Atec Pharmatechnik GmbH
13:00 – 13:30
Panel Discussion and Q&AAshwini Bhisikar
Technical Key Account Manager., Datwyler Pharma Packaging
Jana-Cathrien Müller
Sales Manager, Atec Pharmatechnik GmbH
Serena Panighello
Senior Scientist/SG Lab Analytics, Stevanato Group S.p.A.Cathy Zhao
Director of Scientific Insights Lab, West Pharmaceutical Services, Inc.
- Sponsor Demonstration: West Pharmaceutical Services
- Break
- Market Trends
Brigitte Reutter-HaerleModerator: Tae-soo Lee, Director of Drug Product Department, Samsung Bioepis
14:15 – 14:45
Patient-Friendly Injection Systems, Market Trends & Developments
Brigitte Reutter-Haerle, Vice President Product Management & Marketing, Vetter Pharma International GmbH
Brigitte Reutter-Haerle
Vice President Product Management & Marketing, Vetter Pharma International GmbH
- Safety Syringes, Autoinjectors, Pens and Wearables
Yves Grossenbacher•Minuk Kim•Christian Kollecker•Wenzel Novak•Brigitte Reutter-Haerle•Lyndon WildModerator: Tae-soo Lee, Director of Drug Product Department, Samsung Bioepis
14:45 – 15:15
Safety Syringe in Ready-To-Fill Configuration
Wenzel 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 Autoinjector
Minuk 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 Product
Christian 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
Yves Grossenbacher
Business Development Manager, Ypsomed AG
Minuk Kim
Principal Scientist, Drug Product, Samsung Bioepis
Christian Kollecker
Director Aseptic Technologies, Harro HöfligerWenzel Novak
Glob. Sen. Director Business Development MDS, Gerresheimer Bünde GmbHBrigitte Reutter-Haerle
Vice President Product Management & Marketing, Vetter Pharma International GmbH
Lyndon Wild
Senior Director of Commercial Operation, SHL MEdical AG