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

An innovative ligand, NGL-Impact^® A, developed by Repligen with Navigo through rigorous gene shuffling, screening and multimerization, is the basis of a new capture resin that rivals current industry standards. Partners in innovation, Repligen and Purolite used a proprietary jetting-based bead manufacturing process to develop the novel Protein A resin, Praesto^® Jetted A50, that has been shown to deliver high capacity, caustic stability and bead uniformity. Potential economic benefits include decreased initial resin cost, extended resin lifetime, lower buffer usage and less operation time.

Speaker Bio

Chris has 17 years biotechnology experience, having spent time with GE Healthcare, WAVE Bioreactors and Merck Millipore, advising clients on start-to-finish protein purification and MAb bioprocessing. At Purolite he leads the global commercial operations of the agarose division.

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.