DeokSeok is a QA Lead (NPI and Commercial) at Janssen Vaccines Incheon site. DeokSeok has about 15 years experiences in Quality & Aseptic area and diverse experiences in project which are plant construction project, new-line project and overseas project before joining in J&J. DeokSeok has also diverse inspection experiences including Korean (MFDS), UK (MHRA) and WHO.More information about speaker
Isolators are widely used in the aseptic industry to create a closed, contained and controlled environment. The increasing use of isolator technology is an emerging trend in the pharma and biotech sectors.
During the presentation, you will get an introduction about general isolator working principals and decontamination principals as well as the differences in the design for high-potency vs. non high-potency isolators. In addition, the advantages of CFD and VHP simulations including integrated FAT to minimizing risk and reducing time to the market will be presented.
No-Touch-Transfer (NTT) has become established as a GMP and QRM compliant alternative methodology to introduce pre-sterilized RTU containers into aseptic filling environments. This alternative approach does not rely on disinfection steps applied on outer packaging layers. It is based on multi-layered packaging, sterility maintained through the supply chain and a process design of material transfers through changing GMP grades. In this process, the contents from the secondary bag packaging is ejected without direct contact or exposure to a lower grade of environmental control than the zone the material is entering into. With this methodology there is no need for in-process material disinfection steps like vaporized hydrogen peroxide or e-beam. The system design requirements and qualification approaches for this methodology will be presented to provide practical guidance for application with respect to contamination control zones and airflow characterization.
To keep up with injectable market evolution, pharmaceutical companies and CDMOs need to be able to manage a wide range of toxic/biological risks in different products and packaging types. When an injectable product includes highly biologically active components with e.g. viral vectors, the production process and the entire facility may have to comply with BSL-2 or even BSL-3 requirements, the increasing the complexity of equipment and processes tends to limit production flexibility. At the same time, any high-potent components, such as antiblastic products or monoclonal antibodies linked to cytotoxic components (ADC), may require the entire fill-finish system to qualify up to OEB level > 5, i.e. with release of contaminants outside the isolated environment in amounts lower than 1 µg/m3.
The presentation intends to demonstrate, through a case study, how it is possible to create innovative aseptic isolated production lines able to achieve this goal, using isolator with “full one-pass” ventilation approach. This solution makes possible to treat highly toxic products or products with a high biological risk, minimising the risk of cross-contamination in the ventilation and filtration system. The one-pass design required the creation of innovative balancing chambers and pressure control systems, capable of handling air flow rates three times higher than traditional isolators, while maintaining high pressure, temperature and humidity control requirements.
Thanks to the one-pass design, it is also possible to reduce the duration of tradition decontamination cycles even if a very low hydrogen peroxide residue (less than 0.2 PPM) is requested. A series of studies were carried out for the optimization of the decontamination cycles with spectrometric instruments for analysing the concentration of hydrogen peroxide up to residues of 100 ppb, to avoid any risk towards easily oxidizable products.
Finally, it is analysed the inlet and outlet filter configuration, wash-in-place automatic systems and how the same isolated line can switch from hazardous to non-hazardous products, leveraging the pressure cascade flexibility between the isolator chambers.
Glove Integrity Testing is becoming an increasingly common testing procedure for every pharmaceutical company that has to work with barrier systems for containment and aseptic processing. Regardless the barrier system, the weakest point lies in the gloves.
Since 2008 “EU GMP Annex 1” reiterated the importance of performing glove integrity testing: ”Monitoring should be carried out routinely and should include frequent leak testing of the isolator and glove/sleeve system”. As an updated Annex 1 is about to come out in its final release, the importance of this test will be more relevant than ever.
Considering that Gloves Integrity Testing is going to be almost a daily routine test for every company involved with isolation technologies, it has to be carried out with a validated procedure.
The presentation is going to show the complexity of this test, proposing a repeatable and reliable validated procedure based on the Pressure Decay Method. This method, which follows the international standard ISO 14644-7 Annex E.5, foresees the inflation of the glove up to a target pressure (1000 Pa) and the monitoring of the pressure decay. A correlation between pressure and pinholes size can be proven.
Considering a very frequent testing routine, the test has to be both reliable and fast. Data and results obtained during several experimental campaigns will be presented, allowing to understand the different variables that can influence the testing procedure.
This presentation will focus on innovations in the manufacturing of parenteral packaging components to address the demanding needs for packaging sensitive drugs such as biologics.
The agenda of presentation will include.
• Common concerns in the pharmaceutical industry surrounding parenteral packaging
• Advancements in products and processed to achieve best-in-class specifications, with a focus on ‘zero-defects’
• A quality by design approach for manufacturing components to mitigate industry concerns that relate to particulate and silicon contamination
Environmental Monitoring (EM) is one of the main microbiological controls that the biotechnology and pharmaceutical industries perform.
This ensures the safety and efficacy of pharmaceutical products and is a critical control to consider when companies release their finished drug products to market.
So, EM must be robust and reliable at every single step.
The 3P® ENTERPRISE solution has been developed by bioMérieux to fully address the daily industrial challenges of EM.
3P® ENTERPRISE is an emerging system combined with three key products.
3P® ENTERPRISE provides an end-to-end solution that fully digitalizes and automates the EM process
The first part of the solution is the 3P® SMART PLATES. This plate has GS1 barcode labeling, it can make clear traceability.
3P® CONNECT software** is the second part of the solution. The software automatically and immediately collects, tracks, and saves all the actions and data related to EM. This removes the paperwork process and so decreases the risk of errors and win time during the entire EM process.
Finally, there is the 3P® STATION, an instrument that automates the incubation and counting of microbiological colonies on EM Petri dishes in real-time. A combination of high-performance algorithms and high-definition images taken every hour means that there is a standardized reading of plates - no human error - and alerts raised should a sample exceed its specification, allowing rapid corrective actions.
He currently holds the role of Aseptic Processing, Sales Director Asia-Pacific at IMA Life, a division of IMA S.p.A. His focus is to develop the aseptic filling market, in the assigned area.
In the previous 10 years he holds the role of Isolation Technology Product Manager, within IMA Life.
He held previous positions as Isolation Technology Product and Sales Manager at Comecer S.p.A. and as Technical Trainer for Olivetti S.p.A. His education includes a specialization in electronics.
The EU GMP Annex 1 revision provides more comprehensive requirement from the regulatory with significant improvement over the current version. This session will focus on overall training program covering from training, Aseptic Process Simulation (APS) and qualification of the aseptic operators to meet the requirement from EU GMP Annex 1 revision. The session will share the aseptic operator training program improvements made at Janssen utilizing mock RABS. The operators trained with mock RABS are qualified through aseptic process simulation by demonstrating adequacy of aseptic behavior and interventions. The session will cover the training program as well as the qualification program. In addition, current QA oversight program and oversight personnel training program at Janssen will also be shared.
This seminar will cover a risk-based approach to pass thru decon of critical items into cleanrooms and RABS as well as cleaning BSC Hoods. There will be a focus on how to control hard to kill fungal spores such as Aspergillus and Chaetomium as well as bacterial spores and viruses. Recent case studies from the past few months in cell and gene therapy and compounding pharmacies will be discussed in relation to pass thru decon. Published data will also be mentioned to convey effective methods in control bioburden into the APA. This presentation well be a holistic approach to controlling bioburden from entering BSC Hoods and cleanroom operations.
The dynamics of the industrial revolutions are growing continuously and are more and more noticeable. Industry X.Y leads us through constant transformations unstoppably in all areas of life into new structures and new life forms. Opportunities and possibilities open up, risks get mitigated. Structures known today and regarded as set are changing due to new operational processes, changed work areas, robotics, automation, as well as expanding and far-reaching to complete digitalization.
What does this mean for the life science industry? Are these new technologies even applicable for vaccine productions? Questions like these will be addressed in this lecture. Hereto case studies are presented where the aspects show the technical evolution so far. But not only the state of the art is addressed, as well the view into the next generation of solutions is touched. And last but not least controversial topics are covered for transparent views.
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
For many years, the pharmaceutical industry has been moving towards a connected world. When connecting the complex Bausch+Ströbel filling lines to higher-level systems, a lot of energy needs to be devoted to the identification and connection of the relevant sets of data, the creation of the logical structures and the addition of contextual information. Furthermore, an intelligent evaluation and analysis of the runtime data requires a significant amount of time and effort. With the OMNIA platform Bausch+Ströbel has developed a solution that provides a ready-to-use integration and value-added services already on the day of delivery. The applications can span from GMP and process monitoring, to automatic troubleshooting support or advanced efficiency and maintenance evaluations. All these use cases are centralized in one place – the Bausch+Ströbel OMNIA platform.
The presentation shows a used case of our Ejext X (Inspectif AI) technology, which will explain and demonstrate how this technology will develop automatic Inspection machine recipes and what results we can achieve with that.
It is demonstrated on a Lyo Cake Camerastation at an installed machine at customer site to improve the detection for defects as well as reduce False rejection as much as possible with the problematic of unstable lyo cake condition due to the product.
Director, Digital Industry
Siemens Ltd Seoul
Mr. Peron has been in the field of marketing services for 20 years, with experience in web applications and advanced interactive technologies for pharmaceutical companies.
After holding the role of Marketing & Communication Manager for several years, in charge of coordination and execution of all marketing activities, he is currently Senior Marketing Advisor at Stevanato Group.
Jack Gill will co-present remotely with his PDA revision team co-chair Carol Flynn on TR43 updates. The presentation will focus on changes in this routine revision process that were implemented in 2022. A team of representatives from the Pharma Industry as well as primary container manufacturers spent 2 years reviewing the alignment of the document with current thinking on the criticality of defects, applicability of defects by container type, and suggested proactive approaches to reduce these defects through continuous improvement activities. The process began with the goal of reducing potential for patient or user injuries, loss of manufacturing efficiency and line clearances, and product recalls and worked through how to tie that into a continuous improvement program.
The FDA Draft Guidance “Container/Closure Systems for Packaging Human Drugs and Biologics” was issued in 1999. But in the past decades, there has been a change in the scrutiny of the FDA reviewers looking at E&L data. They have gradually increased the requirements, and for a long time not backed up with any official document until recently by issuing the USP<1663> on assessment of extractables, USP<1664> on leachables and PQRI on best practices for extractables and leachables in parenteral drug products.
In this presentation, the key factors of success of any given E&L project will be highlighted. Crucial is to understand what regulators really want and aligning the design of an E&L study to their expectations.
Only through successful partnering between drug product manufacturers, material suppliers, CRO performing the study and final evaluation by a toxicologist, a true mitigation of the risk related to packing can be established.
In general terms, a prefilled syringe is preferred if ease of use or patient experience are more important than speed or when minimizing product waste is important. As product wastage, there is an indisputable advantage to use syringes, thanks to low overfill needed and accurate dose delivery, especially in some therapeutics areas. The high necessity for drug savings - driven by Covid-19 pandemic for example - coupled with the new wave of high-value biologics with extremely high production costs, every optimization strategy must be explored.
This presentation intends to show the impact of the internal shape of the glass cone on the dead volume, the main contributions from both the glass container and plunger stopper, as well as the strategy to mitigate the risk of drug loss and next development steps.
Dr. Max Fernandez is a regulatory, quality and compliance professional with over 20 years of experience and global leadership in biologics development, regulatory strategy, CMC, quality and compliance, manufacturing and tech transfer covering preclinical to commercial product lifecycle management.
Dr. Fernandez has been based in California for most of his career, making significant contributions to Baxter’s global efforts in the recombinant and plasma products space, and culminating in the US FDA licensure of VONVENDI, the first and only recombinant protein therapy for von Willebrand disease, in 2015. Before coming to China, he was the Head of Global Regulatory Affairs at Samsung Biologics in Korea, where he helped international and domestic clients obtain more than 100 approvals from major health authorities (US FDA, EMA, PMDA, Health Canada, ANVISA, Cofepris, etc.) for over 40 commercial products in 3 years. This remarkable success rate was enabled by over 20 on-site regulatory inspections with no critical observations. As Vice President of Intellective Bio, Dr. Fernandez is committed to helping one of China’s fastest-growing CDMOs meet global standards and making accessible advanced therapies for all.
Dr. Fernandez received his PhD in Analytical Chemistry from the University of California.
Dr In-sook Park is the current Director General responsible for leading Biopharmaceuticals and Herbal Medicine Evaluation Department at the Korean Ministry of Food and Drug Safety (MFDS).
In her current position, Dr Park oversees Biologics, Recombinant Protein Products, Gene and Cell Therapy Products, Herbal Medicines and Cosmetics Evaluation divisions.
Her vast professional experience spans over 30 years in the fields of Pharmaceuticals and Medical Devices safety and efficacy evaluation and Research Planning and Coordination based on Regulatory Science.
In 2021, Dr Park became a member of the Regional Vaccine Advisory Group (RVAG) of ADB.
The U.S. FDA has long aimed to strengthen its use of remote inspection and integrate desk-based assessments with traditional on-site visits. The pandemic has dramatically accelerated that evolution. Welcome to the new era of hybrid inspections. Regulators have found that remote inspections are a very useful and cost-effective tool complementing CGMP compliance verification. With the addition of the virtual component, there is a corresponding increase in the number of investigators and SME on the inspection team. In some recent hybrid pre-licensing inspections for biologics, an inspection team size totaling around ten investigators was reported. What do you need to know to be ready? Come learn about how FDA conducts hybrid biologics / small molecules inspections and best practices for preparing for your pre-approval/licensing inspections. After all, suppose things do not go well, the follow-up re-inspection may not be scheduled for some time, significantly delaying regulatory approval and commercial manufacturing.
Approval of a Biologics License Application is based on an integrated assessment of the product and facilities and upon determination that the product and facilities comply with the standards established in the application and the Good Manufacturing Practice requirements. This presentation will introduce FDA’s regulatory requirements for Biologics License Applications and the CGMP requirements for biotech manufacturing.
This presentation will cover the following topics:
1. Relevant Laws, Regulations, and Guidance for Biologics License Applications,
2. Regulatory requirements for Biologics license applications,
3. The integrated BLA review and inspection program, and
4. A risk- and system- based Pre-License Inspection program of manufacturing facilities.
Ivy Louis is the Founder of VIENNI TRAINING & CONSULTING LLP, holds a Master's degree in Pharmaceutical Sciences and an MBA in Human Resource Management.
Ivy's combined 33 years spanning across teaching, pharmaceutical manufacturing/quality, and service provider experience is distilled into the consultative and educational approaches that her organization-VIENNI Training & Consulting LLP has been delivering from 2010 onwards. The areas of support for pharmaceutical and biopharmaceutical operations rests on building excellence through consulting in parenteral operations and catering to the learning requirements for operating personnel through training & education.
Ivy has been associated with PDA Inc.(www.pda.org) from 2003, as a member. She has been extremely active in spearheading the activities of the Parenteral Drug Association Chapter in India, from 2013 onwards. Ivy has been contributing in the various capacities as a PDA India Chapter Board member between 2013-2019. She has also been a Member of the Steering Committee for Awards in 2017, Member of the Steering Committee for the PDA letter Editorial Committee and a member of the Task Force that is working on an ANSI standard for Quality Risk Management for Aseptic Processing. She is also a member of the Science Advisory Board for PDA Inc.
This presentation provides guidance on the elements of selection and evaluation of Single-Use systems or components. Implementation of Single-Use Systems (SUS) starts with an effective selection of Single-Use components. This is a comprehensive guide to the selection and use of Disposables, as well as the rationale for selecting Disposable over traditional manufacturing systems such as stainless-steel tanks. A focus of the presentation will be on qualifying Disposable for their appropriate use in a process, with particular emphasis on issues that regulators have expressed concerns about, including Extractables and Leachables, and highlighting criteria to select and qualify Single-Use components. The evaluation emphasizes risk management methods to identify the Single-Use components that are best qualified to meet the requirements of your processes.
Aseptic technique is a way to prevent viable microbial contamination during manufacturing of a sterile product. Injectable vaccines have to be manufactured by a stringent aseptic process. This may also be extended for intranasal and oral vaccines. Various ways are used during bulk production which may include 0.1 micron filtration for media and buffer preparation, test for bioburden at various stages and testing for sterility. Blending, filling and lyophilization form a part of filling operations. Aseptic handlings starts with class grades for manufacturing area where aseptic operations are done in Class A with class B background. Gowning qualifications of individuals are strictly followed for Classified areas. Area is monitored by Environmental Monitoring activity. For filling operation RABS ( Restricted Access Barrier System) can be utilized in fill-finish area. Stringency in filling is very vital because there is no fall back mechanism besides rejection of the product.
Recent advancements in bioprocessing have supported the accelerated growth of the biopharmaceutical industry. With the advent of continuous biomanufacturing safety of biologics products continues to be accomplished by a multi-tiered approach involving safety testing measures throughout the development and manufacturing process. The safety program starts with raw material control and involves in-process and bulk lot release tests and evaluation of the manufacturing process to inactivate or remove viruses.
Recent advances in technologies have enabled more effective and directed end point analysis for such studies. These include methods such as nucleic acid testing, automated analyses, marker analysis, genome assessment and updated approaches to viral clearance. The key controls required to perform such testing are critical and qualification of such test to provide suitable results are necessary.
This presentation will provide specific examples of study design, technology advances and regulatory expectation while performing such safety studies.
The Contamination Control Strategy (CCS) should be implemented on all critical control points across the manufacturing to ensure process efficiency as described on EU Annex 1. The effectiveness of the contamination controls should be frequently assessed, actively updated and be able to drive continuous improvement of the manufacturing. It is possible to use appropriate technologies like rapid microbial testing along the process to protect the product and rapidly detect any contaminants.
Optimization through smart monitoring all along the process to prevent deviations and improve process productivity could help achieve benefits such as lean manufacturing, cost efficiency, higher throughput and minimal waste.