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  Jin-Hyun Jeong

  Professor, College of Pharmacy at Yonsei University

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.

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  Jerome Kim

  Director General of International Vaccine Institute

Moderator: Michael Lopez
Panelists: Jerome Kim and David King

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  Jerome Kim

  Director General of International Vaccine Institute
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  David King

  Director, Drug Product Operations of Samsung Biologics
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  Michael Lopez

  Former Senior VP, Global Quality at Medytox

Opening Remarks by the Moderator

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  DeokSeok Oh

  QA Lead (NPI and Commercial) at Janssen Vaccines

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  Hirohito Katayama

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

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  Frode Pedersen

  Computer Scientist at Stevanato Group
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  Andrea Sardella

  Pharma Inspection Product Development Manager at Stevanato Group

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?

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  Nikolai Petrovsky

  Professor of Medicine at Flinders University

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.

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  David Loong

  Senior Consultant Novel Modalities APAC, Bioprocessing Strategy at Merck Life Science

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.

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  Luigi Annoni

  Senior Aseptic Specialist at IMA Life
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  Alberto Penati

  EU Engineering, Senior Director of Patheon Thermo Fisher Scientific

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.

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  Enrico Barichello

  Product Manager at Stevanato Group

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.

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  Derek Duncan

  Director of LIGHTHOUSE Instruments
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  Michael Edey

  Principal Engineer, Component Control & Optimization at Pfizer

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

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  Jia Min Boo

  Technical Account Specialist at West Pharmaceutical Services
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  Derek Duncan

  Director of LIGHTHOUSE Instruments
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  Michael Edey

  Principal Engineer, Component Control & Optimization at Pfizer
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  Sok Tiang Koh

  Vice President - Scientific Affairs & Technical Services at West Pharmaceutical Services
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  Max Fernandez

  Vice President of Quality, Regulatory and Compliance at Shenzhen Cheerland Biomedicine Investment Co.

Opening Remarks by the Moderator

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  Max Fernandez

  Vice President of Quality, Regulatory and Compliance at Shenzhen Cheerland Biomedicine Investment Co.

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.

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  Alexander J. Schaefer

  Technical Product Manager at Wilco AG

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.

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  Max Fernandez

  Vice President of Quality, Regulatory and Compliance at Shenzhen Cheerland Biomedicine Investment Co.

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

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  Max Fernandez

  Vice President of Quality, Regulatory and Compliance at Shenzhen Cheerland Biomedicine Investment Co.
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  Kavita Ramalingam Iyer

  Director/ Team Leader, BioPharm CMC Regulatory Affairs of GSK
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  Christina Juli

  Head of Tech RA Germany III at Boehringer Ingelheim Pharma GmbH & Co. KG
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  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