This is a past event. Registration is closed. View other Parenteral Drug Association - Asia Pacific office events.
Welcome Remarks
Javier Camposano
  • Javier Camposano (Vice President - Head of the Global Drug Product Expansion Division at Celltrion, Inc.)

    Javier Camposano

    Vice President - Head of the Global Drug Product Expansion Division at Celltrion, Inc.

    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.

    More information about speaker
Opening Address
Jin-Hyun Jeong
  • Jin-Hyun Jeong (Professor, College of Pharmacy at Yonsei University)

    Jin-Hyun Jeong

    Professor, College of Pharmacy at Yonsei University

    Dr Jeong is a professor at the College of Pharmacy, Yonsei University International Campus, and holds the positions of Executive General of K-NIBERT Project and Director, Graduate Program of Industrial BioPharmaceutical Science. The Yonsei Campus is located near the plants of Samsung Biologics and Celltrion, a world-class bio companies, and Dr. Jeong maintains a close relationship with these two companies, which is expected to greatly contribute to the development of Korean PD.

    More information about speaker
SESSION 1: Aseptic Manufacturing Process in times of COVID-19, Supply Chain, Primary Packaging Materials
Michael Lopez

Opening Remarks by the Moderator

  • Michael Lopez (Former Senior VP, Global Quality at Medytox)

    Michael Lopez

    Former Senior VP, Global Quality at Medytox
Keynote Speech: From Efficacy to Implementation: Regulatory Strategy and COVID-19 Vaccine Development
Jerome Kim

The first wave of COVID-19 vaccines were developed along an accelerated pathway, with stringent National Regulatory Authority (NRA) Emergency Use (EUA) approval within 11 months of initiation of development. While NRA approval was sufficient for use within countries, in a Global Health context additional steps were required, including referral for World Health Organization (WHO) Emergency use listing (EUL). Among stringent NRAs, EUA was given on the basis of safety and efficacy interim analyses, typically after at least 50 clinical endpoints and 2 months (median) of safety information had been collected in Phase III randomized clinical trials involving active agent and placebo. These trials individually or in aggregate involved tens of thousands of randomized volunteers. There are 13(+) vaccine that now have EUA in various countries, and it will be increasingly difficult to justify the use of placebo controls. The pathway for the so-called wave 1a and 2 vaccines (with interim data expected later this year and early 2022) is complicated by the requirement for active comparators. We will discuss the regulatory pathway for these next wave vaccine with regard to dose, schedule, heterologous prime boost, and correlates of protection.

  • Jerome Kim (Director General of International Vaccine Institute)

    Jerome Kim

    Director General of International Vaccine Institute
From Monoclonal Antibodies to Vaccines: Overcoming Barriers and Providing a Rapid Response to Meet Pandemic Requirements
David King
  • David King (Director, Drug Product Operations of Samsung Biologics)

    David King

    Director, Drug Product Operations of Samsung Biologics

    David King holds a bachelor’s in biology and has 29 years of experience in pharmaceutical and medical device industries. He was a microbiologist during first 5 years of his career at filter manufacturer Gelman Sciences and with a parenteral manufacture, Fuji-Sawa. He spent 7 years as a quality engineer with medical device manufacturers (Volcano and Tandem Diabetes) with a focus on sterilization (steam, gamma and ETO), leading the design/validation of a new sterilization process in-line with production. He has managed aseptic filling production facilities (Parke-Davis, Genentech, Jubilant HollisterStier, Samsung Biologics) for 18 years. He has extensive experience that include: complicated formulations, most container closure systems, tight project timelines, and leading manufacturing to profitability. David currently is the Director of Drug Product Operation at Samsung Biologics in South Korea, leading a team of 200+ employees in the introduction of biopharmaceuticals into established aseptic filling lines for both clinical and commercial markets.

    More information about speaker
Panel Discussion and Q&A
Jerome KimDavid KingMichael Lopez

Moderator: Michael Lopez
Panelists: Jerome Kim and David King

  • Jerome Kim (Director General of International Vaccine Institute)

    Jerome Kim

    Director General of International Vaccine Institute
  • David King (Director, Drug Product Operations of Samsung Biologics)

    David King

    Director, Drug Product Operations of Samsung Biologics
  • Michael Lopez (Former Senior VP, Global Quality at Medytox)

    Michael Lopez

    Former Senior VP, Global Quality at Medytox
Networking Demo Sessions by PTI and IMA LIFE
SESSION 2: Visual Inspection
DeokSeok Oh

Opening Remarks by the Moderator

  • DeokSeok Oh (QA Lead (NPI and Commercial) at Janssen Vaccines)

    DeokSeok Oh

    QA Lead (NPI and Commercial) at Janssen Vaccines
Visual Inspection Case Study
Won Min Kim

The presentation will discuss the challenges encountered during the qualification of a newly installed automatic visual inspection machine, and most importantly, how these challenges were addressed and overcome to have the system qualified for manufacturing operations.

  • Won Min Kim (Assistant Manager, Bio-Process Team at Celltrion Pharm)

    Won Min Kim

    Assistant Manager, Bio-Process Team at Celltrion Pharm
Visual Inspection in The Japanese Market: How a Standardized Calibration is Useful to see Operator’s Unique Capability in Manual Visual Inspection
Hirohito Katayama
  • Hirohito Katayama (Head of Supplier Relationship Management of Cell & Gene Franchise at Novartis Pharma K.K.)

    Hirohito Katayama

    Head of Supplier Relationship Management of Cell & Gene Franchise at Novartis Pharma K.K.

    Hirohito Katayama is the Head of Supplier Relationship Management of Cell & Gene Franchise in Novartis Pharma KK. He has over 35 years of experience in pharmaceutical formulation & technology development, validation, visual inspection, rapid microbiological testing and manufacturing. He is currently the chair of the PDA Japan Chapter Sterile Product GMP Taskforce Regenerative medicine working team. He has been an active member of PDA since 1996. He was a member of the Japanese Pharmacopeia editors in Microbiological Testing for 14 years. He is the chair of ISO TC198 WG9 in Japan.

    More information about speaker
The Way from Manual Inspection to Inspection Supported by AI
Martin Gabler

Different inspection methods and technologies are used in the pharmaceutical industry to minimize the risk of unintended particles entering the patient during the injection of parenteral medication. This presentation gives a brief overview of the different inspection methods (from manual inspection to AI-assisted inspection) applied in each stage of the product development process. It will also discuss how to assess the inspection results of a fully automated machine compared to a human manual inspection (Knapp test). Furthermore the presentation will highlight, how inspection results can be improved by AI to achieve a better detection rate and reduce costly false-rejects in production.

  • Martin Gabler (Product Manager at Körber Pharma Inspection)

    Martin Gabler

    Product Manager at Körber Pharma Inspection
Liquid and Lyophilized Products Inspection Combined in a Single Machine. Enhancing Performances and Flexibility with AI: A Success Story
Frode PedersenAndrea Sardella
  • Frode Pedersen (Computer Scientist at Stevanato Group)

    Frode Pedersen

    Computer Scientist at Stevanato Group

    Frode Stig Nørgaard Pedersen is a Computer Scientist at Stevanato Group working with Computer Vision problems. His main responsibility is to find solutions for Stevenato projects, with an emphasis on LYO products, using Machine Learning. He has also found solutions through the implementation of more conventional algorithms. Other examples of projects that he has been a part of include the analysis of satellite images of fields to ensure proper growth rates, autonomous driving in simulated environments and an agent that was tasked with learning how to play board games using reinforcement learning and self-play.

    More information about speaker
  • Andrea Sardella (Pharma Inspection Product Development Manager at Stevanato Group)

    Andrea Sardella

    Pharma Inspection Product Development Manager at Stevanato Group

    Andrea earned his Degree in Physics from Padua University in 1989 and his Master’s Degree in Nuclear Engineering in 1990. As researcher at the National Research Council (C.N.R.), he developed several optoelectronic and nuclear scientific instruments for Magnetically Controlled Fusion Research setting up international collaboration with UWA Madison (USA) and Garchin IPP (De). After 10 years in the research sector, he moved to the industrial sector developing optical and vision controls for industrial application as CEO of a small-medium company. This experience drove him into the pharmaceutical field, where he started to develop several control applications with vision and spectroscopy tools. After several years, he joined a leading company in this sector as R&D Manager and he developed innovative inspection technology for the inspection machines.

    Since 2008 he has been with Stevanato Group as Pharma Inspection Product Development Manager to develop new automation and inspection products dedicated to the pharmaceutical customers of the group.

    More information about speaker
Panel Discussion and Q&A
Martin GablerHirohito KatayamaWon Min KimDeokSeok OhFrode PedersenAndrea Sardella

Moderator: Deok Seok Oh
Panelists: Won Min Kim, Hirohito Katayama, Martin Gabler, Frode Pedersen and Andrea Sardella

  • Martin Gabler (Product Manager at Körber Pharma Inspection)

    Martin Gabler

    Product Manager at Körber Pharma Inspection
  • Hirohito Katayama (Head of Supplier Relationship Management of Cell & Gene Franchise at Novartis Pharma K.K.)

    Hirohito Katayama

    Head of Supplier Relationship Management of Cell & Gene Franchise at Novartis Pharma K.K.
  • Won Min Kim (Assistant Manager, Bio-Process Team at Celltrion Pharm)

    Won Min Kim

    Assistant Manager, Bio-Process Team at Celltrion Pharm
  • DeokSeok Oh (QA Lead (NPI and Commercial) at Janssen Vaccines)

    DeokSeok Oh

    QA Lead (NPI and Commercial) at Janssen Vaccines
  • Frode Pedersen (Computer Scientist at Stevanato Group)

    Frode Pedersen

    Computer Scientist at Stevanato Group
  • Andrea Sardella (Pharma Inspection Product Development Manager at Stevanato Group)

    Andrea Sardella

    Pharma Inspection Product Development Manager at Stevanato Group
SESSION 3: COVID-19 and Novel Technologies
Javier CamposanoMicheal Schafferius

Opening Remarks by the Moderators

  • Javier Camposano (Vice President - Head of the Global Drug Product Expansion Division at Celltrion, Inc.)

    Javier Camposano

    Vice President - Head of the Global Drug Product Expansion Division at Celltrion, Inc.
  • Micheal Schafferius (Application Specialist for Separation Technologies and Quality at Sartorius)

    Micheal Schafferius

    Application Specialist for Separation Technologies and Quality at Sartorius
Keynote Speech: The COVID-19 Pandemic – Where Did It Come From and Where Is It Going?
Nikolai Petrovsky

Overall, the data indicates that from the earliest isolates SARS-CoV-2 was surprisingly well adapted to bind strongly to human ACE2, explaining its high infectiveness and rapid transmission through the human population. The big question is how did the virus originally get this human adaptation, in nature or through human intervention? This talk will explore the broader significance of these and other unexplained findings on the somewhat unusual SARS-CoV-2 genetic structure, and attempt to answer the question on everyone’s lips – is this a man made virus?

  • Nikolai Petrovsky (Professor of Medicine at Flinders University)

    Nikolai Petrovsky

    Professor of Medicine at Flinders University
Clinical Production of Human Injectable siRNA Nanoparticle Therapeutics
Edward Wang

This presentation will focus on the operational elements for a GMP facility establishment, biologics aseptic production success. Emphasize the importance of investing time and effort in validating a production line, training fill line teams to be operationally the center of excellence. Authors believe it can lead to great economic benefit by significantly reducing risk of un-releasable product batches. Drawing mainly from the author’s experience, insights into contamination control, critical steps for aseptic processing, and what companies need to do and how to do it based on QbD, will be shared as a roadmap to win in biologics FFF and aseptic production.

  • Edward Wang (Chief Technology Officer, China Operations at Sirnaomics Inc.)

    Edward Wang

    Chief Technology Officer, China Operations at Sirnaomics Inc.
Make it Right: Best Practices for mRNA Manufacturing
David Loong

Vaccines and therapeutics based on RNA have the potential to transform disease prevention and treatment. However critical decisions need to be made when developing processes to manufacture mRNA to ensure that the drug substance has consistent performance and safety. This presentation will highlight key quality considerations when manufacturing mRNA for use in pharmaceutical applications.

  • David Loong (Senior Consultant Novel Modalities APAC, Bioprocessing Strategy at Merck Life Science)

    David Loong

    Senior Consultant Novel Modalities APAC, Bioprocessing Strategy at Merck Life Science
Panel Discussion and Q&A
Javier CamposanoDavid LoongNikolai PetrovskyMicheal SchafferiusEdward Wang

Moderators: Javier Camposano and Micheal Schafferius
Panelists: Nikolai Petrovsky, Edward Wang and David Loong

  • Javier Camposano (Vice President - Head of the Global Drug Product Expansion Division at Celltrion, Inc.)

    Javier Camposano

    Vice President - Head of the Global Drug Product Expansion Division at Celltrion, Inc.
  • David Loong (Senior Consultant Novel Modalities APAC, Bioprocessing Strategy at Merck Life Science)

    David Loong

    Senior Consultant Novel Modalities APAC, Bioprocessing Strategy at Merck Life Science
  • Nikolai Petrovsky (Professor of Medicine at Flinders University)

    Nikolai Petrovsky

    Professor of Medicine at Flinders University
  • Micheal Schafferius (Application Specialist for Separation Technologies and Quality at Sartorius)

    Micheal Schafferius

    Application Specialist for Separation Technologies and Quality at Sartorius
  • Edward Wang (Chief Technology Officer, China Operations at Sirnaomics Inc.)

    Edward Wang

    Chief Technology Officer, China Operations at Sirnaomics Inc.
2 Demo Sessions: 1st Networking Demo Session by Oliver Healthcare Packaging || 2nd Networking Demo Session by MERCK

(1) Oliver Healthcare Packaging Demo
TITLE: “The Relationship Between Packaging Adhesives and Particulate Generation in Nested Syringe Tubs”
PRESENTER: Santosh Madival, Senior Principal Engineer, Technical Services (Asia-Pacific)

(2) Merck Demo

SESSION 4: Prefilled Syringes
Gabriele Peron

Opening Remarks by the Moderator

  • Gabriele Peron (Senior Marketing Advisor at Stevanato Group S.p.A.)

    Gabriele Peron

    Senior Marketing Advisor at Stevanato Group S.p.A.
INJECTA, Advanced Robotic Solutions for Multi-Product Manufacturing
Luigi AnnoniAlberto Penati

In today’s pharmaceutical and biopharmaceutical industry, new therapies employ a greater number of different products manufactured in medium-to-low production batches. INJECTA, IMA Life’s innovative approach to handling RTU components, ensures a high degree of flexibility thanks to the intensive use of robotic-driven manipulations. INJECTA responds to the increasing complexity of new drug substances improving product quality, and manufacturing safety and efficiency. Our challenge is to push back the barriers even further to provide the market with a solution offering both agility and compliance, through advanced robotics to achieve true gloveless processing.

  • Luigi Annoni (Senior Aseptic Specialist at IMA Life)

    Luigi Annoni

    Senior Aseptic Specialist at IMA Life
  • Alberto Penati (EU Engineering, Senior Director of Patheon Thermo Fisher Scientific)

    Alberto Penati

    EU Engineering, Senior Director of Patheon Thermo Fisher Scientific
Important considerations for aseptic technique
Beth Kroeger

The objective of aseptic processing is to maintain sterility of a product, assembled from sterile components, under operating conditions to prevent microbial contamination. The goal is to keep microorganisms and particles out of manufactured products that are injected into humans, yet humans are the biggest contributors, and the impact of poor aseptic technique is not immediately evident. The speaker will draw upon PDA Technical Report 70, Fundamentals of Cleaning and Disinfection Programs for Aseptic Manufacturing Facilities and cover cleaning and disinfection best practices, regulations, SOP development, how to handle unplanned events, and techniques for working in ISO 5/Grade AB spaces.

  • Beth Kroeger (Technical Services Senior Manager, Life Sciences Division at STERIS Corporation)

    Beth Kroeger

    Technical Services Senior Manager, Life Sciences Division at STERIS Corporation
Glass Prefillable Syringes: A Manufacturing Strategy to address Bio-Drugs Concerns
Enrico Barichello

Pre-fillable syringes are the industry’s platform choice to further innovative drug products. Due to the complexity of injectable biologics, several aspects need to be considered when selecting a pre-fillable syringe, like silicone oil, tungsten, other extractables, etc.

To address these concerns, PFS manufacturers implemented an upgraded process based on technological innovations that combine pharmaceutical glass processes and products into high value-added systems.

In this presentation, we will provide an overview of the most advanced glass pre-fillable syringes manufacturing processes, with specific attention on:
Cutting-edge production and inspection technologies;
The integration of Artificial Intelligence to increase process capabilities;
A PFS solution for sensitive biologics;
The available and suggested PFS options offered in the market:
Aspects to include to make the right choice when selecting a pre-fillable syringe.

  • Enrico Barichello (Product Manager at Stevanato Group)

    Enrico Barichello

    Product Manager at Stevanato Group
Panel Discussion and Q&A
Luigi AnnoniEnrico BarichelloRichard ChaiAlberto PenatiGabriele Peron

Moderator: Gabriele Peron
Panelists: Alberto Penati, Luigi Annoni, Richard Chai and Enrico Barichello

  • Luigi Annoni (Senior Aseptic Specialist at IMA Life)

    Luigi Annoni

    Senior Aseptic Specialist at IMA Life
  • Enrico Barichello (Product Manager at Stevanato Group)

    Enrico Barichello

    Product Manager at Stevanato Group
  • Richard Chai (Technical Service Manager at Steris)

    Richard Chai

    Technical Service Manager at Steris
  • Alberto Penati (EU Engineering, Senior Director of Patheon Thermo Fisher Scientific)

    Alberto Penati

    EU Engineering, Senior Director of Patheon Thermo Fisher Scientific
  • Gabriele Peron (Senior Marketing Advisor at Stevanato Group S.p.A.)

    Gabriele Peron

    Senior Marketing Advisor at Stevanato Group S.p.A.
SESSION 5: Container Closure
Sok Tiang KohMax Fernandez

Opening Remarks by the Moderators

  • Sok Tiang Koh (Vice President - Scientific Affairs & Technical Services at West Pharmaceutical Services)

    Sok Tiang Koh

    Vice President - Scientific Affairs & Technical Services at West Pharmaceutical Services
  • Max Fernandez (Vice President of Quality, Regulatory and Compliance at Shenzhen Cheerland Biomedicine Investment Co.)

    Max Fernandez

    Vice President of Quality, Regulatory and Compliance at Shenzhen Cheerland Biomedicine Investment Co.
Use of  Quality Risk Management to Generate a Contamination Control Strategy for Container Closure Integrity of a COVID-19 Vaccine
Derek DuncanMichael Edey

Recent changes in regulatory guidance on container closure integrity (CCI) have triggered an evolution in best practices to ensure that sterile product has good CCI. A science based holistic approach involves not only validating a deterministic CCI test method to generate robust science-based CCI data on the chosen primary packaging components, but also qualifying the vial sealing (capping & crimping) process with an in-process monitoring tool during real time production.

A principle laid out in the draft Annex 1 is a requirement for processes and manufacturing activities, that they should be managed in accordance with Quality Risk Management (QRM) to generate Contamination Control Strategies. This is to provide a proactive means of identifying, scientifically evaluating and mitigating potential risks to quality. QRM approach should be applied when developing new product CCIT requirements. Additionally, the use of a QbD approach across the lifecycle of the product results in robust process validation outcomes.

Data was generated for the Pfizer Covid-19 vaccine project which when presented demonstrates a holistic approach of ensuring good CCI. This used a QRM approach by documenting the plan and outcomes in a risk assessment with QbD principles applied. CCI data was generated using test methods based on laser-based headspace analysis while data on the capping and crimping process was generated using residual seal force (RSF) testing. The established correlation between RSF and CCI proved to be instrumental in providing a high degree of assurance of the robust CCI throughout the product – package container life cycle. Generating this data for the Covid-19 vaccine was critical due to a possible risk to CCI posed by the deep cold storage temperature (-80 C). The science based holistic approach described is useful for upcoming therapies needing ultra-cold chain for storage and distribution.

  • Derek Duncan (Director of LIGHTHOUSE Instruments)

    Derek Duncan

    Director of LIGHTHOUSE Instruments
  • Michael Edey (Principal Engineer, Component Control & Optimization at Pfizer)

    Michael Edey

    Principal Engineer, Component Control & Optimization at Pfizer
Factors Influencing Closure Functional and Moisture Performance
Jia Min Boo

Sharing two important quality concerns of rubber closure for pharmaceutical injectables industry.
Particulates have always been one of the top reasons for drug recalls and a focus for the pharmaceutical industry to ensure patient safety and compliance. Therefore, we will explore, in particular, intrinsic rubber particles possibly generated from the rubber stoppers of a vial system; how they are generated, factors resulting in their generation and corresponding ways to reduce the risk.

Lyophilization is a way to increase stability of drug products. An overview of lyophilization technology would highlight the criticality of moisture control for lyo drugs. We will hence examine considerations for moisture control including study data to share some general findings.

  • Jia Min Boo (Technical Account Specialist at West Pharmaceutical Services)

    Jia Min Boo

    Technical Account Specialist at West Pharmaceutical Services
Panel Discussion and Q&A
Jia Min BooDerek DuncanMichael EdeySok Tiang KohMax Fernandez

Moderators: Sok Tiang Koh and Max Fernandez
Panelists: Michael Edey, Derek Duncan and Jia Min Boo

  • Jia Min Boo (Technical Account Specialist at West Pharmaceutical Services)

    Jia Min Boo

    Technical Account Specialist at West Pharmaceutical Services
  • Derek Duncan (Director of LIGHTHOUSE Instruments)

    Derek Duncan

    Director of LIGHTHOUSE Instruments
  • Michael Edey (Principal Engineer, Component Control & Optimization at Pfizer)

    Michael Edey

    Principal Engineer, Component Control & Optimization at Pfizer
  • Sok Tiang Koh (Vice President - Scientific Affairs & Technical Services at West Pharmaceutical Services)

    Sok Tiang Koh

    Vice President - Scientific Affairs & Technical Services at West Pharmaceutical Services
  • Max Fernandez (Vice President of Quality, Regulatory and Compliance at Shenzhen Cheerland Biomedicine Investment Co.)

    Max Fernandez

    Vice President of Quality, Regulatory and Compliance at Shenzhen Cheerland Biomedicine Investment Co.
NETWORKING DEMO SESSION BY OPTEK SYSTEMS: POSITIVE CONTROLS FOR CONTAINER CLOSURE INTEGRITY TESTING, AN INTEGRATED APPROACH AND RECENT ADVANCEMENTS

Presenter: Chris Randon, Head of Micromachining

SESSION 6: Container Closure
Max Fernandez

Opening Remarks by the Moderator

  • Max Fernandez (Vice President of Quality, Regulatory and Compliance at Shenzhen Cheerland Biomedicine Investment Co.)

    Max Fernandez

    Vice President of Quality, Regulatory and Compliance at Shenzhen Cheerland Biomedicine Investment Co.
Container Closure Integrity of Parenterals – Past, Present and Future
Andrea Simonetti

Main items to be discussed
• Why Container Closure Integrity (CCI) is Needed?
• Worldwide regulatory guidances and standards on CCI:
• How to keep up with regulatory and quality requirements
• How to ensure product quality and patient safety through equipment, deterministic methods and
testing strategies
• What impact these regulations have on pharmaceutical manufacturers
• Decision tree for the most appropriate method
Agenda
1. Regulations, Standards and Guidance Overview
➢ History
➢ EU Annex 1 – Manufacture of Sterile Medicinal Products
✓ Broadening the coverage over sterile products
✓ Relevant aspects
➢ USP <1207> - Sterile Product Package Integrity Evaluation
✓ New structure
✓ New Concepts and Details
o Product life cycle package testing
o Leak test method risk-based selection criteria
o Leak test instrument qualification, method development and validation
o Leak test methods details, applications and studies
➢ New PDA TR on Package Integrity Testing
➢ Latest news from FDA and EU Regulatory Agencies
2. Technology overview and in-depth discussions
➢ Systems currently available on the market
✓ Description and scope
✓ Applications
✓ Leak size detection limit
✓ How to deal with parameters: configuration, validation, operation
✓ Advantages and limitations
✓ Side by side comparisons
3. Applications
➢ Product and Container VS test method
➢ Choose the most appropriate metho

  • Andrea Simonetti (Independent Pharmaceutical Advisor)

    Andrea Simonetti

    Independent Pharmaceutical Advisor
Automated Inspection of Vials with Lyophilizates
Alexander J. Schaefer

If you have ever wanted to automate your visual inspection of lyophilized vials and are wondering how you can integrate container closure integrity testing with it, then this content is made for you.
In this presentation, the author, Alexander J. Schaefer, will give you an insight into his experience in past projects from inception of the idea until the production of the first commercial batches.
The presentation has two major parts, the first giving an overview on how an equipment manufacturer arrives at the final design of the solution, starting from initial requirements as presented by clients, over the creation of the mutual baseline up to the inspection station design.
The second part dives deeper into container closure integrity testing, namely the design of HeadSpace Analysis (HSA) and Near-Infrared Spectroscopy (NIR) and presents the latest findings of WILCO’s Lab and R&D.

  • Alexander J. Schaefer (Technical Product Manager at Wilco AG)

    Alexander J. Schaefer

    Technical Product Manager at Wilco AG
Panel Discussion and Q&A
Max FernandezAlexander J. SchaeferAndrea Simonetti

Moderator: Max Fernandez
Panelists: Andrea Simonetti and Alexander J. Schaefer

  • Max Fernandez (Vice President of Quality, Regulatory and Compliance at Shenzhen Cheerland Biomedicine Investment Co.)

    Max Fernandez

    Vice President of Quality, Regulatory and Compliance at Shenzhen Cheerland Biomedicine Investment Co.
  • Alexander J. Schaefer (Technical Product Manager at Wilco AG)

    Alexander J. Schaefer

    Technical Product Manager at Wilco AG
  • Andrea Simonetti (Independent Pharmaceutical Advisor)

    Andrea Simonetti

    Independent Pharmaceutical Advisor
Networking Demo Session by West Pharmaceutical Services
Session 7: Accelerating Approvals through Regulatory Convergence in APAC
Michael Lopez

Opening Remarks by the Moderator

  • Michael Lopez (Former Senior VP, Global Quality at Medytox)

    Michael Lopez

    Former Senior VP, Global Quality at Medytox
A Review of Current Regulatory Requirements for the Licensure of Biosimilars, in the US and in China
Max Fernandez

The abbreviated licensure pathway afforded biosimilar products presents a growing commercial opportunity not just for global manufacturers, but for Chinese producers who have, or are building, the capacity and technical capability for large-scale manufacturing of biologics such as monoclonal antibodies. Since the Biosimilar User Fee Act (BsUFA) was authorized in 2012, the US FDA has drafted several guidances for industry that have enabled sponsors and applicants to clearly chart a pathway for commercialization of biosimilars in the US. In contrast, China’s National Medical Products Administration (NMPA) has only recently made it clear how biosimilars, which are important to the strategic growth of the domestic biotech market, are afforded the same abbreviated licensure pathway. In this presentation, which should be of interest to anyone considering licensure of biosimilars in China, Max Fernandez compares and contrasts the regulatory basis for licensure of biosimilars in the US and in China; notes key considerations for biosimilars product development; and reviews the current status and future prospects for commercialization of biosimilars in China.

  • Max Fernandez (Vice President of Quality, Regulatory and Compliance at Shenzhen Cheerland Biomedicine Investment Co.)

    Max Fernandez

    Vice President of Quality, Regulatory and Compliance at Shenzhen Cheerland Biomedicine Investment Co.
An Industry's Perspective on the Current Challenges and Potential Solutions for the Regulatory Lifecycle Management of Biologicals and Vaccines in South Korea
Kavita Ramalingam IyerChristina Juli

CMC post-approval strategies are the approaches companies take to meet the needs of global health agencies for example when improving manufacturing processes, increasing capacity. Considering the growing complexity, time and resources needed for getting CMC changes approved globally for biopharmaceutical products, it would be in the best interests of patients, health authorities and MAHs to work together to ensure the greatest possible level of patient access to the medicines that will save or improve their lives. This presentation illustrates the complexities and impact of the current post approval change management situation, current mitigation strategies and transformational recommendations for driving improvement.

  • Kavita Ramalingam Iyer (Director/ Team Leader, BioPharm CMC Regulatory Affairs of GSK)

    Kavita Ramalingam Iyer

    Director/ Team Leader, BioPharm CMC Regulatory Affairs of GSK
  • Christina Juli (Head of Tech RA Germany III at Boehringer Ingelheim Pharma GmbH & Co. KG)

    Christina Juli

    Head of Tech RA Germany III at Boehringer Ingelheim Pharma GmbH & Co. KG
Panel Discussion and Q&A
Max FernandezKavita Ramalingam IyerChristina JuliMichael LopezXiaoXiao Yue

Moderator: Michael Lopez
Panelists:
Max Fernandez
Christina Juli
Kavita Ramalingam Iyer
XiaoXiao Yue, Head of the Drug Administration Department, Market Regulation Bureau of Huangpu District, Guangzhou, China

  • Max Fernandez (Vice President of Quality, Regulatory and Compliance at Shenzhen Cheerland Biomedicine Investment Co.)

    Max Fernandez

    Vice President of Quality, Regulatory and Compliance at Shenzhen Cheerland Biomedicine Investment Co.
  • Kavita Ramalingam Iyer (Director/ Team Leader, BioPharm CMC Regulatory Affairs of GSK)

    Kavita Ramalingam Iyer

    Director/ Team Leader, BioPharm CMC Regulatory Affairs of GSK
  • Christina Juli (Head of Tech RA Germany III at Boehringer Ingelheim Pharma GmbH & Co. KG)

    Christina Juli

    Head of Tech RA Germany III at Boehringer Ingelheim Pharma GmbH & Co. KG
  • Michael Lopez (Former Senior VP, Global Quality at Medytox)

    Michael Lopez

    Former Senior VP, Global Quality at Medytox
  • XY

    XiaoXiao Yue

    Head of the Drug Administration Department at Market Regulation Bureau of Huangpu District
Closing Remarks

Note: This program is correct at the time of the release but may be subject to changes without prior notice.