Conference Introduction
Keynote Speech: From Monoclonal Antibodies to Vaccines: Overcoming Barriers and Providing a Rapid Response to Meet Pandemic Requirements

Dr. Jerome Kim, International Vaccine Institute Korea

Vaccines Production

SBL

Panel Discussion and Q&A
Break / Networking Session
Case Study – Celltrion Syringes Visual Inspection Challenges

Won Min Kin, Celltrion

The Way from Manual Inspection to Inspection Supported by AI
Christian Scherer

Christian Scherer, Seidenader

  • Christian Scherer (Executive Vice President - Sales at Körber Pharma Inspection)

    Christian Scherer

    Executive Vice President - Sales at Körber Pharma Inspection
Liquid and Lyophilized Products Inspection Combined in a Single Machine. Enhancing Performances and Flexibility with AI: A Success Story
Andrea Sardella

Andrea Sardella, Pharma Inspection Product Development Manager, Stevanato Group

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

    Andrea Sardella

    Pharma Inspection Product Development Manager at Stevanato Group
Panel Discussion and Q&A
Keynote Speech: COVID Vaccine Development

Nikolai Petrovsky

Q&A
INJECTA, Advanced Robotic Solutions for Multi-Product Manufacturing
Penati AlbertoLuigi Annoni

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.

Penati Alberto, EU Engineering, Senior Director, Patheon Thermo Fisher Scientific
Luigi Annoni, Senior Aseptic Specialist, IMA Life

  • Penati Alberto (EU Engineering, Senior Director of Patheon Thermo Fisher Scientific)

    Penati Alberto

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

    Luigi Annoni

    Senior Aseptic Specialist at IMA Life
Important considerations for aseptic technique

Beth Kroeger, Senior Technical Service Manager (Steris)

Glass Prefillable Syringes: A Manufacturing Strategy to address Bio-Drugs Concerns

Enrico Barichello, Stevanato

Panel Discussion and Q&A
Break / Networking Session
Annex 1 and Data Integrity

EMA Speaker (TBC)

Topic (TBC)

Max Fernandez, Samsung Biologics (Invited)

An Industry's Perspective on the Current Challenges and Potential Solutions for the Registration and Regulatory Lifecycle Management of Biologicals and Vaccines in South Korea
Dr. Christina Juli

Christina Juli, Head of Global Tech, Boehringer Ingelheim
Kavita Ramalingam Iyer, Director/ Team Leader, BioPharm CMC Regulatory Affairs, GSK

  • Dr. Christina Juli (Head of Global Tech at Boehringer Ingelheim Pharma GmbH & Co.)

    Dr. Christina Juli

    Head of Global Tech at Boehringer Ingelheim Pharma GmbH & Co.
Panel Discussion and Q&A
Container Closure Integrity

Hirorito Katayama, Novartis

CCI Case study

Edward Wang, Chief Technology Officer, China Operations, Sirnaomics Inc

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, West Pharmaceuticals

  • 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
Break / Networking Session
Factors Influencing Closure Functional and Moisture Performance

Container Closure Integrity of Parenterals – Past, Present and Future

Andrea Simonetti, Director of Sales & Marketing, Pharma Inspection Equipment, Xepics

Optic Systems / PTI
Panel Discussion and Q&A
Closing Remarks