Opening Remarks by the Committee Chairperson

• 

  Hue Kwon

  VP, Head of Quality, Samsung Bioepis

Dr. Marasa's presentation will cover a high-profile summary of the most common observations (Inspection Findings) related to sterility assurance seen by Facility Inspectors as summarized in forms 483 and discussed with Facility Management during Pre-Approval Inspections or For-Cause Inspections.

• 

  Bernard Marasa

  Pharmaceutical Scientist, Center for Drug Evaluation and Research, Food and Drug Administration

As of August 25th of this year (effective date of EU/PICS Annex 1), there is a regulatory requirement to provide continuous viable monitoring not only in the Grade A environment, but the surrounding Grade B areas as well. In the realm of microbiology, Environmental Monitoring often requires multiple days to more than week to collate and evaluate data to determine contamination counts and identifications of recovered microorganisms. This presentation will offer potential methodologies to improve the time-to-detection of viable contamination results as well as moving towards real-time analysis of the environment.

• 

  Marc Glogovsky

  Business Unit Manager - Microbiology Consulting, Valsource Inc

The presentation will focus on Hanmi’s experience in operating an Aseptic Manufacturing Process for prefilled syringe production within Fill and Finish products. It will also discuss control strategies used for aseptic process in prefilled syringe production from an industry perspective. The presentation will feature case presentations on how the company improved its existing operating system in response to the revised regulations of the EU Annex 1. The hardware required to build a Contamination Control System and the direction of improving the operating system will also be discussed. In addition, case studies on investigation and CAPA activities against deviations experienced during RABS operations for aseptic process control will be presented.

• 

  Hyun Cheol (Charles) Kim

  Vice President and Head of Plant, Pyeongtaek Bio Plant, Hanmi Pharm. Co., Ltd.

• 

  Marc Glogovsky

  Business Unit Manager - Microbiology Consulting, Valsource Inc
• 

  Hyun Cheol (Charles) Kim

  Vice President and Head of Plant, Pyeongtaek Bio Plant, Hanmi Pharm. Co., Ltd.
• 

  Wayne Lee

  Fast Trak™ Validation Services Leader, Global, Cytiva
• 

  Seung Hwan Oh

  Site Quality Head, Quality, Janssen
• 

  Mohammad Rashedi

  Data Scientist, Amgen

This proposal was devised from the work of PDA Technical Report 44, Quality Risk Management for Aseptic, and was put forward by one of the original Technical Report members, Mr. Harold Baseman, ValSource LLC.

The proposed standard draft document is intended to provide a lifecycle approach using a holistic evaluation of contamination control systems designed to prevent contamination during aseptic processing and ultimately ensure the safety of the products when delivered to the patient. The proposed standard is applicable to aseptic processes used to manufacture sterile, microbiologically controlled, and low bioburden regulated health care products. It is applicable to pharmaceutical, biological, and ATMP (Advanced Therapeutic Medicinal Products). This proposed standard does not supersede or replace national regulatory requirements, such as Current Good Manufacturing Practices (CGMPs) and/or compendial requirements that pertain to a particular national or regional jurisdiction.

During the 20 minutes discussion, the team will discuss on the background of what the proposed standard is intended to serve besides the benefits of adopting this to identify quality risks for Aseptic processing and management of those risks, proactively.

• 

  Amanda Bishop-McFarland

  Senior QRM and Microbiology Consultant, ValSource
• 

  Noel Long

  Senior Sterility Assurance Adviser, Cytiva
• 

  Ivy Louis

  Founder, VIENNI® TRAINING & CONSULTING LLP
• 

  Christine Roberts

  Senior Standards Manager, Parenteral Drug Association

The release of FDA draft guideline 'Inspection of Injectable Products for Visible Particulates' led to a heightened focus within pharmaceutical industry. This guideline clearly delineates the expectations that industry must achieve a profound understanding of the sources of particulates, utilize appropriate analytical methods for rigorous monitoring, and deploy effective strategies to ensure that the final product is essentially free of visible particulates.

Leveraging Janssen's experience in FDA inspection approvals, this presentation aims to share Janssen's approach to meet industrial standard. This involves the initiation of a comprehensive risk assessment to scrutinize the sources of particles, distinguishing between intrinsic and extrinsic particles. Additionally, highlighting the significance of adopting a life cycle management approach, enabling the industry to proactively identify and mitigate risks associated with visible particulates, thereby ensuring product quality and safety throughout the product's life span.

• 

  MinYoung Kwon

  Engineer, Manufacturing Science and Technology (MSAT), Janssen Vaccines

Gene and cell therapy medicinal products are different from traditional medicinal products in terms of their novelty, complexity, and technical specificity. Therefore, EU/US/Korea has new regulations for gene and cell therapy medicinal products; REGULATION (EC) No 1394/2007 21 CFR Subchapter F Biologics, 21 CFR part 1271—HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS, and Advanced regenerative medical treatment and Advanced Biopharmaceutical Safety and Support Act. Korea ATMP regulation has different Requirements, Scope, and Characteristics distinguished from EU and US. Uniquely, Korea ATMP requires a special license of the company which manufactures Human Cells as a drug substance of ATMP.

• 

  Heonho Jung

  Associate Director, Novartis Korea

Aseptic Processing and ATMPs how does this match. Looking into the latest published guidelines like the PIC/s Annex 2 A for ATMPs, Microbiological or Particular Contamination should be avoided even the cells received from the patient might be already contaminated. How to prevent additional Contamination? Currently the manufacturing takes often place within BSC “Bio Safety Cabinets” working with open products and manual operations which pose the highest risk to the product and patient. Closed technologies like singe use system, Barrier or higher automation does reduce this risk and will be explained with their important to consider implementing strategies.

• 

  Richard Denk

  Senior Consultant Aseptic Processing & Containment, Skan AG

• 

  Hue Kwon

  VP, Head of Quality, Samsung Bioepis

Making quality improvements in aseptic operations requires a way of thinking that leads to efficient and highly reliable supplies of products. This presentation looks firstly at the ‘Why’ adopting a higher level of maturity benefits all stakeholders and then covers the ‘How’ to make the change. Finally, the presentation will show ‘What’ a Quality Management Maturity Model looks like in practice. As the US FDA prepares to publish its current thinking of QMM, there are equally important drivers to embarking on growing your maturity model.

• 

  Michael Cutter

  Chief Quality Officer, Biocon Biologics ltd

As the healthcare manufacturing sector looks into the near future, leaders are concerned that there will be a shortage of technical experts in the area of sterility assurance. Sterility assurance, in its broad sense, includes a number of sterility modalities – aseptic processing, irradiation, steam, and gas. Without an adequate number of people with varying degrees of technical knowledge, skill and expertise, it is the patients who will be most acutely affected.

To help remedy this lack of skilled professionals, the Society for Sterility Assurance Processionals was formed to identify knowledge, skills, and experiences that individuals, manufacturers, regulators, and educational delivery organizations can use to help ensure there is an adequate number of people in these critical roles.

This presentation provides the background for SfSAP and its efforts to help develop the next generation of sterility assurance professionals.

• 

  Arthur Dumba

  Director and General Manager, The Society for Sterility Assurance Professionals (SfSAP)

• 

  Jinwoo Kim

  Compliance Manager, Samsung Bioepis
• 

  Bobby Crawford

  Director, Business Development, Quality Executive Partners

Much like modular autoinjector platforms, modular assembly, testing, and final assembly equipment platforms leverage the competitiveness associated with traditional platforms –speed, scale, and comparatively lower costs – while offering additional flexibility to accommodate a range of designs and development models. Featuring a standardized equipment base, the modular approach results in machine bases that can be adjusted to process a mix of different products, or several versions of the same product, at speed, on a flexible scale, and with consistent quality. This Tech Talk will address the technology and benefits of the modular platform strategy and also provide a guide to the most suitable assembly, testing, and final assembly solutions for different medical device projects.

• 

  Lyndon Wild

  Global Head, Project and Program Management, SHL Medical AG

The rising demand for prefilled syringes is attributed to the growing prevalence of chronic diseases, technological advancements, rising adoption of self-injection and supporting government regulations. In this session, we will walk you through the latest updates on TR-43-2 and focus on how speed to market has become a differentiating factor for success in the pharma industry. To quickly bring new drug delivery devices to market, pharma companies, device suppliers, and contract manufacturers must build strong and efficient partnerships and establish robust supply chain channels. Finally, the session will provide valuable insights on how to cope with challenges related to primary and secondary packaging components on device assembling process from a CDMO perspective. The audience can expect to hear highlights about some of the key market and manufacturing issues and adopted solutions linked to drug devices, packaging and more.

• 

  Gabriele Peron

  Senior Marketing Advisor, Stevanato Group S.p.A.

This paper will illustrate a case study about challenges and solutions faced in a joint project to bring to the market an innovative autoinjector 1ml/2.25ml. A deep analysis of unmet needs of biopharmaceutical clients and patients pushed two leading companies in device design/manufacturing to combine their efforts in a collaboration to enhance the resilience of supply chain.

In the presentation the following critical points will be investigated:

- How to reduce risk through dual sourcing options
- Introducing auto-adjust plunger technology to allow for various fill volumes and both the 1ml/2.25ml PFS
- How to guarantee control and continuity on providing end-to-end support from primary container, to manufacturing, analytical services, and final assembly equipment/support
- Define a set of key learnings and recommendations based on real experience

• 

  Michael Earl

  Director of Pharmaceutical Services, Owen Mumford
• 

  Steven Kaufman

  Vice President, Drug Delivery Systems, Stevanato Group S.p.A.

• 

  Susanne Hall

  Director, Secondary Packaging & AVI Projects, VETTER PHARMA
• 

  Bettine Boltres

  Director Scientific Affairs & Technical Solutions, Glass Systems, West Pharmaceutical Services
• 

  Steven Kaufman

  Vice President, Drug Delivery Systems, Stevanato Group S.p.A.
• 

  Gabriele Peron

  Senior Marketing Advisor, Stevanato Group S.p.A.
• 

  Michael Earl

  Director of Pharmaceutical Services, Owen Mumford

• 

  Michael Lopez

  President and CEO, HSL BioTechnologies Inc

EU GMP Annex 1 of the European Medicines Agency (EMA) is the governing regulatory document related to manufacture of sterile medicinal products. The latest revision, which came into force in August 2023, is a significant update with stronger focus on risk management and the implementation of a contamination control strategy.

Among other methods Container Closure Integrity Testing (CCIT) and Process Analytical Technologies (PAT) can be used for confirming the effectiveness of contamination prevention and is as such a part, if not a corner stone of the contamination control strategy.
Within the presentation novel methods confirming container integrity and sterility during the aseptic filling process as demanded by the revised Annex will be shown. Data from feasibility studies, both in-house as well as from pharmaceutical companies, will be presented confirming a method for holistic container closure integrity testing, data driven results as well as the potential for time and cost savings.

• 

  Matthias Hiddemann

  Technical Product Manager, Wilco AG

• 

  Matthias Hiddemann

  Technical Product Manager, Wilco AG
• 

  Michael Lopez

  President and CEO, HSL BioTechnologies Inc
• 

  Paul Lopolito

  Senior Manager, Technical Services, STERIS
• 

  Lyndon Wild

  Global Head, Project and Program Management, SHL Medical AG
• 

  Carina Van Eester

  Global Platform Leader of Prefilled Syringes and Cartridges, Datwyler