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Day 1 | Day 2
7:20am Registration and Morning Coffee
8:20 Chairperson’s Opening Remarks
Michael Dekleva, Ph.D., Senior Director, Worldwide Regulatory Affairs, Merck Sharp & Dohme, Corp.
8:30 Opening Keynote Presentation
Regulatory Authority Perspective on Handling Vaccine Production, Manufacturing and Process Change
Norman Baylor, Ph.D., Director, Office of Vaccines Research and Review, Center for Biologics Evaluation and Research (CBER), Food and Drug Administration, FDA
This talk will address industry concerns regarding the importance of validation of the manufacturing process and validation of assays and will examine assessment of the immunological response. It will offer practical advice on managing manufacturing change and putting together a comparability package, and provide examples of changes that have required approval including incidents of when clinical data have been required. Biography
9:15 Production of Influenza Vaccines Using a Fungal Production Platform
Debbie Higgins, VP, Vaccine Development, Neugenesis Corporation
New technologies for producing influenza vaccines are needed. A Neurospora crassa fungal production platform is being developed to rapidly produce large amounts of immunogenic and protective influenza virus-like particles (VLPs) containing hemagglutinin, neuraminidase and matrix 1 protein. Host cell growth is extremely fast, the system is completely animal-free, and virus growth is not required. Production strains can be stably stored and the system can be used to generate tailored multivalent vaccines. Biography
9:45 Case Study on Designer Duck Cell Lines and Vectored Vaccines AGE1-CR: A Production Platform for Vectored Vaccines
Volker Sandig, Ph.D., VP, Probiogen, A.G.
Modern vaccines require efficient scalable production processes. Permanent cell lines growing to high cell densities overcome limitations associated with primary cells and chicken eggs and are endorsed by industry. With a defined history and well characterized cell banks they provide a better documentation and higher safety margin and enable the development of virus and protein products with unique properties. The cell line AGE1.CR was created by directed immortalization of retina cells of a single Muscovy Duck embryo and extensively tested following EMEA and FDA guidelines. They represent the core of a versatile vaccine and protein production platform. We will discuss challenges and solutions for scaling production of pox-and alphavirus-vectored vaccines. Biography
10:15 Networking Coffee Break with Exhibit and Poster Viewing
11:00 Optimization of a Process for an Attenuated Influenza Vaccine Produced on Vero Cells
Thomas Muster, Ph.D., CEO, AVIR Green Hills Biotechnology, A.G.
Avir Green Hills Biotechnology is developing a cell culture-based production system for a replication-deficient live attenuated influenza vaccine. The vaccine is produced on Vero cells and a chromatography based purification process is being successfully employed for the pilot-scale production for clinical phase 1 and 2 material. A case-study addressing challenges such as strain-change variations, process optimization, and scale-up to commercial scale manufacturing will be presented. Biography
11:30 Designing and Validating a Manufacturing Process
Trevor Deeks, Ph.D., Senior Director, Manufacturing Operations and Engineering, Contract Manufacturing Group, Emergent BioSolutions, Inc.
This presentation links the Quality by Design (QbD) concept with the validation activities required for the process. It looks at the early stages of process design at a very high level through the technique of process mapping to identify the key inputs and outputs from the process, how they need to be studied to provide an understanding of the process, the importance of establishing process robustness and the need to characterize the process. The presentation will cover the validation and other documentation aspects briefly and will also provide some advice on establishing the validation requirements and realistic acceptance criteria. Finally it will look at things that go wrong and how they may be avoided. Biography
12:00pm Purification Platform for Influenza Viruses and Vaccines
Matjaz Peterka, Ph.D., Manager, Molecular Biology, BIA Separations
The presentation will describe development and optimization of a monolith chromatography based influenza virus purification process successfully employed for the production of replication-deficient live attenuated vaccine for CP I and CP II trials. During the presentation different methods with an emphasis on anion and cation exchange chromatography on monolithic supports will be presented. The robustness of the methods has been tested with diverse subtypes of influenza A and influenza B viruses. Virus yields were estimated in terms of infectious virus particles and total virus particles. Key data on virus yield, host cell DNA and protein removal will be presented. Finally, strategy for process scale up will be discussed.
12:30 Luncheon Presentation Technological Advances for Vaccine Processingsponsored by
Ian Sellick, Director of Marketing, Pall Life Sciences
While there has been significant implementation of single-use technologies in vaccine production, the core unit operations have remained essentially the same. In this presentation, we look at new methods for processing at two critical, but time consuming stages. Harvesting complex fragments, such as cell walls to manufacture recombinant vaccine antigens, a method that can also be applied to many other particulate and solubilization steps, and simplifying tangential flow filtration steps used for antigen concentration, fractionation and diafiltration and turning them into a single-pass process. Both of these techniques lend themselves to single-use operation, reduce process time, increase yields through simpler, shorter, less energy-intensive processes, can be applied to multiple products and process steps and have the potential to become platform technologies.
1:55 Chairperson’s Remarks
Tony Brazzale, Vice President, Business Development, BIA Separations
2:00 Challenges and Solutions to Downstream Bioprocessing Operations for the Manufacture of Vaccine Candidates
Timothy Lee, Ph.D., Deputy Director, Bulk Manufacturing, sanofi pasteur
A systematic methodology for the clarification of bacterial proteins for extracellular or intracellular bacterial proteins is described. The chosen methodology was based on process economics, recovery and purity of the clarified material prior to downstream column purification. We selected centrifugation for the initial step of clarification. For extracellular proteins, a final ultrafiltration step is usually performed, and for intracellularly-expressed proteins, clarification using microfiltration and final ultrafiltration is preferred. Other methods such as a direct capture step and ion-exchange membrane technologies were also investigated to determine if they could reduce downstream steps, improve recovery and reduce overall process cost while maintaining high purity. Biography
2:30 Purification Development for a Live Attenuated Influenza Virus from MDCK Cell Culture
Simon Hsu, Ph.D., Principal Scientist, Vaccine Process Biochemistry, MedImmune, Inc.
The increasing demand for seasonal flu vaccine and risk of a pandemic pose an unprecedented challenge to current egg-based manufacturing. MedImmune has developed a MDCK cell culture production platform. Cellufine® Sulfate (CS) affinity gel column chromatography was used to purify the influenza virus. This was a key step for degraded host cell DNA (HCD) removal in the presence of Benzonase®. For scale-up from 20L cell culture to 400L, the capacity of CS gel was further explored. HCD levels in this second generation process were reduced and helped to increase the CS column dynamic binding capacity by more than three fold. Biography
3:00 Manufacturing a Sterile, Autologous Colon Tumor Derived Vaccine for a Patient Specific Immunotherapeutic Treatment
Michael G. Hanna, Ph.D., Chairman & CEO, Vaccinogen, Inc.
The ultimate approval of OncoVAX®, an immunotherapeutic formulation composed of sterile, viable, irradiated, non-tumorigenic autologous tumor cells, with or without fresh-frozen mycobacteria of TICE BCG, presented technical pharmacological challenges centered on the use of conventional drug product sterilization procedures. The issues resolved were sterility of the product, and complete product characterization studies using the methodology of Flow Cytometry. The latter resulted in developing an automated Matrix Associated Potency and Identity Assay that met the specifications of the FDA. A clinical bioequivalence study was conducted and accepted by the FDA suggesting that these manufacturing modifications did not destroy the immunological essence of the vaccine. Biography
3:30 Networking Refreshment Break with Exhibit and Poster Viewing
4:15 Spray Drying in Vaccine Manufacturing for Improved Stability
Tom Jin, M.D., Scientist, Principal Investigator, Technique Operations & Manufacturing, Aeras Global TB Vaccine Foundation
Based on our AERAS 402 vaccine, the benefits and challenges of manufacturing spray dried products will be discussed. Shorter processing cycle time and larger batch size per unit operation compared with lyophilization improve the commercial application of the spray drying technique. However, challenges exist in transferring the concept into a final product, such as: 1) Developing a stable formulation that gives a high recovery during the spray drying process and is hydrophobic during shelf storage; 2) The aseptic cGMP spray dryer design; 3) Powder filling; 4) Developing economic unit-dose packs or blister capsules for final product and DPI; 5) Cost effectiveness. Biography
4:45 Development of a Recombinant Vaccine to Treat Vaginal Candidiasis – From the Bench to Clinical Testing
Rinaldo Zurbriggen, Ph.D., Co-founder, Pevion Biotech, and Senior Program Manager, Lonza Ltd.
Vaginal Candida infections have emerged as a significant medical problem during the last few decades. Innovative vaccine approaches are needed to induce local mucosal immunity in order to cure recurrent vulvovaginal candidiasis. In animal challenge studies, recombinant Secreted Aspartyl Proteinases-antigen (Sap2) delivered by influenza virosomes are able to induce protective immune responses. An innovation vaccine delivery system (Influenza virosomes, VLP) combined with a new application form will be presented. In addition, the tech transfer from lab scale to cGMP production scale will be discussed. The vaccine candidate is currently in a phase 1 clinical study. Biography
5:15 Scale-Up of a Plasmid DNA Purification Process Based on PlasmidSelect Xtra for Production of GMP Grade pDNA For Vaccination and Transfection Clinical Studies
Tony Hitchcock, Head, Manufacturing Technologies, RecipharmCobra Biologic Ltd.
This presentation will be based around work performed within RecipharmCobra Bio, using the Plasmid Select Xtra resin to improve and enhance an existing production platform used for the large scale production of clinical grade plasmids. It will focus on works performed with challenging plasmids with inherently high levels of host DNA and open plasmid circle forms, and subsequent works performed to streamline the process, to reduce processing times and operational costs. Biography
5:45 Reception with Exhibit and Poster Viewing
6:45 End of Day
Day 1 | Day 2