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Post Conference Workshop Day

9:00 AM Disposables - Sustainability and Process Economy in Biopharmaceutical Manufacturing - A Reality Check

Joachim Walter, Consultant, Walter Biotech Consultancy
Single-use Technology (SUT) and the general use of disposables have evolved into a widely accepted and applied alternative both in process development, pilot plant as well as manufacturing. However, SUT and disposables are not necessarily a reasonable choice at any scale or application neither is the entire process chain typically feasible for the sole use of disposables. Accordingly, since the introduction of disposables and single-use equipment to biopharmaceutical manufacturing there is an ongoing controversial discussion on the advantages and disadvantages versus a conventional stainless steel environment.
This workshop will focus on the very different arguments for the application of equipment as a consumable, including advantages and limitations of single-use technology, understanding improvement of process robustness, contribution to lean production as well as environmental impact of disposables.

Attend this workshop in order to:
· Understand there is no single and simple argument pro or contra which could be taken as a decisive answer, and that there is the need to analyze in which environment, at what conditions and for what purpose disposables and single-use equipment are being used.
· Uncover what the best practice is for use of single-use equipment for scales significantly beyond 1000L and that the thorough cost/benefit calculation on the use of disposables is in relation to the number of batches to be performed.
· Know how to make the decision for your facility (whether it be mostly single use or conventional) will affect not only equipment but also the structure and contour of the operating staff. Such thoughts on personnel requirements are widely independent from financial investment but rather focus on global location and availability and/or access to skilled personnel.
· Hear how single-use equipment can significantly lower the complexity of operation thus enabling or at least facilitating manufacturing operations.
· Discover the needs and requirements to achieve profitable biopharmaceutical manufacturing are as heterogeneous as are the ideas and concepts of the individual companies, depending on their product portfolio, the targeted market and their capabilities and capacities. Thus there is no single or dominant rationale for the application of single-use technology and disposables which is generally applicable
In a “classical” facility design any validation cost effort can easily be distributed to a considerable number of production runs thus contributing only to a non-decisive amount to the overall production costs. The scale for such plant is nearly unlimited as is the scale of operation. The “flexible” approach using disposables and single-use equipment offers significant advantages regarding changeover work and time thus a high throughput of different processes will definitely take profit as any cleaning and related validation and costly analytics doesn’t apply to a larger extent. Dealing with sophisticated technologies, well-trained staff is a key to successful operation, but such personnel are not necessarily available where needed.

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Joachim Walter

Consultant
Walter Biotech Consultancy

12:00 PM Networking Lunch

1:00 PM Develop Extensive Methodologies and Apply a Risk Based Approach to Identify Extractables and Leachables in Pharmaceutical Products

The demand for increasingly extensive methodologies for designing studies to identify Extractables and Leachables in pharmaceutical products by regulators is growing. Data from these assessments identifies potential contaminants that migrate from containers, closure systems, tubing, and other materials,potentially rendering drug products unsafe,

Attend this workshop in order to:
• Develop a comprehensive approach to identifying compounds extracting from materials under
elevated temperatures, extended contact time, or solvent exposure with help from an Extractable
and Leachable expert
• Understand the impact of process parameters
• Hear novel and innovative approaches to risk assessment
• Discover analytical techniques used to quantify and measure Extractables and Leachables BPOG’s
Best Practice Guide for Testing
• Discover best practice and analytical considerations of Leachables testing methods
• Learn about leachable study design for Single-Use components
• Hear about risk assessment using a standard RA model approach

About Toxikon:
Toxikon is an ISO/IEC 17025-accredited Contract Research Organization (CRO) registered with the FDA for
biologics, drugs, and medical device testing. With approximately 200 employees, Toxikon is committed
to staying at the forefront of biotech product development. Toxikon’s safety services include toxicology
(acute, sub chronic, and chronic toxicity, reproductive toxicity, genetic toxicology, and carcinogenicity),
pharmacokinetics, toxicokinetics, bioavailability, ADME, chemical characterisation, impurities analysis and
synthesis, bioanalysis, and microbiology.
To meet all applicable international GxP requirements, Toxikon’s facilities are fully registered with FDA
and USDA, and accredited with the Association for the Assessment and Accreditation of Laboratory and
Animal Care International (AAALAC), and the International Organisation for Standardisation (ISO). Toxikon
also has assurances with the National Institutes of Health so federally funded work can be performed at
our facilities in compliance with NIH’s Public Health Service Policy on Human Care and Use of Laboratory
Animals (PHS Policy).
Along with our comprehension of regulatory, scientific, and commercial environments, Toxikon offers
extensive testing services and capabilities for biotechnology product development. With more than
30 years of experience, we are committed to excellence in the quality of our testing services, technical
expertise, instrumentation, facilities, and our people, which are all central to your product’s successful
development.