Bioprocessing Breakthroughs and Solutions that Work

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

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

Alvotech developed an intensified Fed-batch process using the XCell™ ATF technology for the production of a complex fusion protein. The process uses the novel technique of High Productivity Harvest (HPH), which involves a traditional Fed-batch process and a clarification process using the XCell™ ATF System. Implementing the new process resulted in higher vcd and viability, improved product quality, and a reduction of cost of manufacture compared to the conventional Fed-batch process.

Contributors

Andrew Falconbridge, Senior Director Process Technology, Alvotech

Protein concentration is one of the critical quality attributes of fill-finished drug products, as it ultimately defines the dosage a patient receives. Process analytical tools are key in monitoring this attribute and are used to control the manufacturing process accordingly. This presentation will give an overview of the journey from initial laboratory feasibility tests of the FlowVPE®  technology to implementation into an aseptic GMP facility.

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 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.

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 (ADCs, cytotoxic linker drug) will be presented.

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.

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

Recently, as part of process development and improvement, TFF technologies have been given additional attention for purification, concentration, and formulation of enteroviruses vaccine candidates. This presentation will explain how Repligen systems have contributed for improved process integration, flexibility, and scale-up.

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.