Abstract

ATF and TFF cell retention technologies were evaluated in our HDPB continuous process at lab and manufacturing scale. The filtration technologies were aligned at lab scale using common engineering criteria resulting in a comparable growth, productivity and product quality. A general overview of lessons learnt on the scalability, interchangeability and robustness at different scales will be given.

Contributors 

Joseph Shultz, Head-Biologics Technology & Innovation Strategy, Advanced Process and Manufacturing Technologies, Novartis Pharma
Ying Jing, Senior Strategy and Technology Leader, Cell Culture, Advanced Process and Manufacturing Technologies, Novartis Pharma

Speaker Bio

David joined Novartis in 2015 and has been actively contributing to the development and scale-up/scale-down of new upstream bioprocesses. Prior to that, he obtained his PhD degree in Chemical Engineering / Bioprocessing from Imperial College London (2014) and his MSc in Biochemical Engineering from TUDelft (2007).

His research interests lie in the area of mammalian cell bioprocessing, scale-up/down, mathematical modelling, data analysis and optimisation.

Abstract

The innovation team at Merck Serono is currently developing a continuous purification platform to support improvement of cell culture processes productivity. This presentation will emphasize the benefits of pre-packed purification technologies for the development of the Merck continuous purification process. The journey will span from robot assisted early development to final trials of the process at pilot scale, highlighting how Repligen solutions eased and facilitated several development activities

Speaker Bio

Victor Pasquier is a process engineer specialized in protein purification at Merck Healthcare in Corsier-sur-Vevey, Switzerland. Since 2016, Victor is involved in technological and process innovation activities at Merck, including chromatography-related projects, process intensification, and next-generation processes development. Victor received his M.Sc. in biotechnology from the engineering school CPE Lyon, France.

Abstract

In response to customers challenged with bioburden-sensitive TFF processes, technology leading single-use TangenX™ TFF flat sheet cassettes are now available in closed and irradiated format. Used in ultrafiltration and diafiltration, the new cassettes come pre-assembled and pre-tested, using the same proprietary membrane choices and multiple MWCOs as SIUS™ flat sheet cassettes. This session will demonstrate how the new cassettes integrate easily into any process with faster turnaround time, improved productivity and lower risk of contamination.

Speaker Bio

Michael LaBreck is Bioprocessing Sales Specialist for TangenX™ TFF products at Repligen starting in December 2016.  Before that, he supported the TangenX™ product line at NovaSep 2008- 2016. He has over 20 years experience with tangential flow filtration applications support in the biopharmaceutical industry.  He has held various sales and applications engineering positions with Pall Corporation and GE Healthcare. Michael has a Bachelor of Science degree in Mechanical Engineering from Syracuse University. 

Abstract

Protein concentration defines the dosage a patient receives and therefore represents a critical quality attribute of fill-finished drug products. Process analytical tools monitoring this attribute and control the manufacturing process accordingly. This presentation will trace the FlowVPE technology implementation journey from initial laboratory feasibility tests to validation within an aseptic GMP facility of the. 

Speaker Bio

Raf De Dier holds a Master’s degree in Chemical Engineering and obtained his PhD at the University of Leuven in Belgium and ETH Zürich in Switzerland. He joined Janssen R&D in 2016 as responsible for the process development and tech transfer support for liquid and lyophilized drug products in the parenteral fill-finish pilot plant. He currently works as a Senior Scientist Manufacturing Science and Technology, where he leads PAT and process improvement projects and manages activities such as concept, design and implementation of new equipment and technologies. 

Abstract

Antibody–drug conjugates (ADCs) consist of a monoclonal antibody linked with a highly potent cytotoxic drug. The antibody primarily targets the drug to tumor cell receptors and secures internalization while the cytotoxic drug kills the targeted tumor cells.

Protecting both the product from environmental contaminants and the staff from exposure to the drug product are key manufacturing quality measures. While glass and stainless-steel systems may effectively protect operators, they require significant equipment decontamination and cleaning validation. As an alternative, single –use technologies offer specific benefits-but also come with their own challenges. Approaches and challenges to safe handling of both antibodies and high potency molecules (ADC, cytotoxic linker drug) will be presented.

Speaker Bio

Ruud Verstegen is DSP Process Engineer at Synthon Biopharmaceuticals based in Nijmegen in the Netherlands. He studied biochemistry at HAN University of Applied Sciences and has over 15 years work experience in the biopharmaceutical industry. His work experience includes development of veterinary viral vaccines at MSD Animal Health and development of human bacterial vaccines at Nobilon (Merck). Since 2011, he works within the Down Stream Processing department at Synthon BV, and is involved in process development for production of antibodies and antibody drug conjugates including scale-up, tech transfer to a GMP manufacturing facility and process validation.

Abstract

As a bioprocessing innovator with technology expertise in filtration, Repligen has developed a breakthrough clarification and harvest technology that can signal a paradigm shift in mAbs and Gene Therapy bioprocessing. A result of continuous innovation at Repligen, the solution integrates advances in multiple disciplines, combining novel polymer technology, various filtration modes, hardware, systems and automated process management. Potential benefits to productivity, product quality, yield and workflow efficiency will be discussed.

Speaker Bio

Shelly Parra has over 20 years of experience in biotherapeutic process development, scale-up, technology transfer, manufacturing, and validation. She is currently the head of the global Field Applications team at Repligen and works with customers optimizing and scaling both upstream and downstream unit operations.  Prior to Repligen, Parra was employed at Thermo Fisher Scientific, Amgen, Transkaryotic Therapies, and BASF Bioresearch. She holds BS and MS degrees in Biotechnology from Worcester Polytechnic Institute in Massachusetts.

Abstract 

Intravacc is a renowned, not-for-profit R&D organization for translational vaccinology. The company focus on the development, innovation and optimization of vaccines, vaccine processes and vaccine technologies. The track record includes vaccines as polio, measles, DPT, Hib and Influenza vaccines.

More recently, and as part of the process development and improvement, TFF technologies have received additional attention for purification, concentration, and formulation of enteroviruses vaccine candidates. In this presentation will be explained how Repligen systems have contributed for improved process integration, flexibility, and scale-up.      

Speaker Bio

Leila Dias holds a master degree in Biological Engineering from Lisbon Technical University, and a Professional Doctoral Engineering (PDEng) in Bioprocess Design, from Delft University. She joined Intravacc in 2018 Leila Dias as the Sr DSP scientist in the Process Development of Viral Vaccines. In this role, her focus in on the development and production of innovative vaccines, including virus inactivation, and process optimization, for phase I and II. Her work is strongly driven by quality by design, with an emphasis in process characterization supported by high throughput process development tools, for the fast development of safe, robust and cost effective processes. Prior to this role, through her career she collaborated with several companies and research institutes, including Novartis, Solvay, TNO, DSM, Fujifilm, Synco Biopartners, UniQure and Sanquin in a wide range of biotech projects.