ISPE LA Half Day Aseptic Processing for Today and Tomorrow
September 9, 2014
Justin Cantor, PSC Biotech
Merritt Postma, IMALife
DPR Newport Beach
4665 MacArthur Court, Suite 100
Newport Beach, California 92660
Aseptic processing presents unique operational challenges in the pharma/biotech manufacturing world, and the expectations of regulators keep increasing. Take advantage of the experience of industry experts as they share their insights on where the bar is currently and how high it is being raised. Join us as we discuss current regulatory expectations and industry trends related to compliance, validation, facilities, equipment, single-use components, advanced aseptic techniques, and environmental controls.
Current Trends in Advanced Aseptic Processing
Sterling Kline RA, Vice President of Design, IPS
This presentation provides an overview of current trends in the pharmaceutical industry focusing on Business Trends, Regulatory Trends, Facility Design Trends and Process Technology Trends. It will address the approach Large Pharma, Generic and CMO manufacturers are following in adopting advanced aseptic technologies in the US as well as world markets. From a Regulatory perspective, the presentation will focus on how the FDA is addressing barrier technology and other recent technological advancements as well as harmonization issues between the FDA and other Regulatory Agencies. An overview of the new technologies will be provided along with the impact they have on facility designs. Finally, several case studies that utilize cutting edge technology will be presented.
Sterling Kline is a Registered Architect, Licensed Construction Contractor and Degreed Engineer. He has over forty eight years design experience, 30 years in the pharmaceutical industry where he served in various senior engineering and manufacturing management roles at New England Nuclear, Dupont-Merck, Dupont Pharmaceuticals, and Bristol-Myers Squibb. He also has 18 years experience managing major architectural and engineering firms. He is currently Vice President of Design at IPS, a leading international pharmaceutical consulting firm. Sterling’s facilities experience includes strategic business planning, master planning, site selection, conceptual design, detailed engineering and construction management for projects ranging up to $2B. He is a recognized expert in integrated facility design including aseptic, OSD and biologic technologies. He is a Member of ISPE and PDA and has lectured frequently at industry venues as well as Rutgers University and Boston Architectural Center. He currently lectures in FDA training programs for auditors on pharmaceutical manufacturing technologies.
Compliance and Validation Aspects of Aseptic Fill and Finish
Charles Heldebrant, Ph.D., Chief Scientific Officer and Quality Officer, PSC Biotech
The aseptic filling of sterile products requires the highest level of aseptic design, operations, controls and practices to assure sterility. This presentation highlights issues you should consider and the system to assure sterility when designing and operating an aseptic filling facility. The guiding premise is that no amount of successful media fills [or anything else] can be used to validate poor aseptic design, operations, controls and practices.
Charles Heldebrant, Ph.D. is the Chief Scientific Officer and Quality Officer at PSC Biotech. He has 28+ years of experience with Alpha Therapeutic Corporation (formerly Abbott Scientific Products Division) and 4+ years of experience with National Genetics Institute/LabCorp. He has extensive experience in biological and pharmaceutical product development, regulatory affairs, quality systems, process design, equipment and process validation, analytical methods validation and computer validations. He has audited and worked with foreign and US development partners to evaluate API and final drug product, process and facilities and has worked to help development partners achieve cGMP compliance. He is also a science consultant for an animated science program, Sid, the Science Kid, for pre-school children.
Market Requirements and Solution for a Small Scale, cGMP Freeze Dryer
Frank DeMarco, Product Manager, Freeze Dryers, US IMA Life
A brief overview of lyophilization and loading fundamentals will frame the examination of market needs for a small scale freeze dryer system designed for high value, for human use, product. Trends in the market would indicate there is movement toward smaller lots of high value product, where a freeze dryer with cGMP aseptic features are required along with highest reliability. However many elements of an Industrial cGMP freeze dryer do not scale in terms of size or economics to small scale. Presentation discusses the specific areas of the freeze dryer design that are opportunities for new engineered solutions to achieve a small scale freeze dryer with industrial scale reliability and a price point proportional to scale. Discussion of what are the market needs for freeze dryer features and options are also covered, and how to optimally configure such a freeze dryer. A proposed design will be presented.
Frank has been with IMA Life for 20 years, serving in a variety of roles including Mechanical Engineering Supervisor, Engineering Manager, Production Manager, and Technology Manager. In 2012 he became the Product Manager – Freeze Dryers for the US market. Frank received his BSME from Clarkson University and spent 12 years with Praxair prior to Joining IMA.
Trends in Aseptic Filling
Lisa Dorn, PE
This discussion will cover RABS and Isolators with presentation of some case studies. Some of the questions we will be exploring include: What are the types of RABS? How are RABS and Isolators different? How do you choose the separation strategy? What should you consider before finalizing your design?
Lisa is a registered professional engineer with over 30 years of experience in project management and process design for pharmaceutical, biotech and food and beverage projects. She has experience in all phases of project design and management including master planning, conceptual and detail design, construction period services, equipment procurement, commissioning, qualification, project scheduling, and peer reviews. Lisa’s areas of expertise include cGMP facility design, Aseptic Processing, Pharmaceutical Fill Finish, and Project Management.
Aseptic Dosing: Where We’ve Been & Where We’re Going
Jessica Frantz, Field Marketing Manager, Biotech Aseptic Transfer Technology, Sartorius Stedim
This presentation will focus on the general trends and requirements of Aseptic Filling processes. We will go over the Regulations surrounding the Critical Process Steps and discuss how these are different in Traditional and Flexible manufacturing environments. We will also walk through the new Single-Use options available in Aseptic Dosing Systems, going over the advantages and challenges associated with these new technologies.
Jessica Frantz is the current Field Marketing Manager for Sartorius Stedim Biotech’s Aseptic Transfer Technologies. In this position she focuses on Single-Use solutions for systems involving the movement of components and fluids into and out of aseptic manufacturing spaces. Prior to this she was the Product Manager for Bosch Packaging Technology’s Single-Use Dosing Systems where she specialized in the development, qualification and validation of their disposable dosing technologies. Jessica has also worked as a Project Engineer for Eli Lilly, where she focused on the specification, purchase, installation, qualification & validation of aseptic filling equipment. Jessica received a Bachelor of Science in Chemical Engineering from Rose-Hulman Institute of Technology, assisted in authoring a section of the PDA Single-Use Guidance, is on the Scientific Advisory Board for the IBC Single-Use Conference, has been a Board member of the BPSA and is an active member of ISPE.
Lessons Learned/Case Study: Starting up new Aseptic Filling Facility
Richard Ramirez, Director of Facilities, Engineering and Maintenance, Grifols Biologicals Inc.
In this presentation we will view an engineering approach when designing a new Aseptic Filling Facility based on lessons learned focusing mainly on two aspects, 1) Humidity and Temperature control with case study, 2) Adequate areas and components for maintenance purposes. The Grifols Gamunex Facility in Los Angeles was originally designed for IGIV. Even though the processes are similar, nevertheless, they are not identical. Standardization can come a long way when designing a new facility for the future can sometimes be uncertain and being able to adapt to changes in a fast pace and critical environment will give you an edge by preventing major upgrades or complete re-designs. Understanding the why behind FDA and other regulatory agencies requirements are a key factor when deciding how to design and maintain control of your process.
Richard Ramirez is the Director of Facilities, Engineering and Maintenance at Grifols Biologicals Inc. in Los Angeles, California and has 20+ years of experience in Electrical, Mechanical and Software engineering in Industries like Machine Tool Technology, Aerospace, Automotive, Medical Device Tooling and Biopharmaceutical Manufacturing. With Grifols acquisition of Alpha Therapeutics Richard has played a major role in the introduction of new automated technology to a previous conventional plant working with process design and specification, process validation, regulatory affairs, quality systems. Some of his strengths are multi-trend analysis, multi-project management, statistical analysis and process control, research and development to name a few. Richard is also a board of director’s member for ISPE LA Chapter.