Leveraging prior knowledge increases the predictability of MAb & ADC commercialization
Monoclonal antibodies and Antibody-drug conjugates are important therapeutics in the field of oncology. The market for these biologics is becoming increasingly competitive as companies continue to innovate and develop new molecules for existing disease targets with greater efficacy. Furthermore, developers of biosimilars are hoping to steal market share from licenced products. To be successful firms must have manufacturing assets that allow flexibility, speed to market and facilitate process transfers without adding unnecessary operational complexity.
End-to-end processing solutions for MAbs and ADCs help improve a company’s competitiveness by reducing risks associated with uncertainties in manufacturing process development and scale-up. Knowledge from previous projects is leveraged to design flexibility into production assets while minimizing regulatory risks and allowing enhanced process understanding.
Establishing these production platforms requires companies to consider their overall objectives and use the right tools during early stage process development. This includes selecting the right partners for process development, applying the appropriate laboratory-scale technologies and using process-modelling tools to predict commercial-scale performance and costs.
Register for our webinar to learn how to approach process development to deliver standardized end-to-end bioprocess platforms for MAbs or ADCs that meet your requirements for quality, speed-to-market, scalability and performance.
Presented by
Ian Schwartz,
Process Development Consultant
Ian Schwartz recently joined Sartorius Stedim Biotech as a Process Development Consultant. Ian has over 12 years of experience in the biotechnology industry and specializes in anybody-drug conjugates (ADCs) and downstream protein purification processes.
He began his career at Biogen Idec and then moved to ImmunoGen where he became fluent in ADC process development, technology transfer and manufacturing operations. Ian then worked for MedImmune where he managed a manufacturing operations team. Most recently, he worked for Agensys (affiliate of Astellas Pharma) where he started up and managed the ADC process development group, technology transfer, and manufacturing support for a number of years.
With more than 12 years in the biotechnology industry, Ian supports, in his current role, process development and scale up of biological processes for Sartorius customers
Jan Schäfer,
Manager Process Applications
Jan Schafer manages the Process Engineering team at Sartorius Stedim Biotech. In this role he is providing his customers with process solutions and consultancy from concept to realization. He has previously held roles in both project and product management and has over 10 years' of experience in bioprocess engineering and design.
His most significant accomplishments include a pilot and commercial scale project to design and implement a global single-use downstream platform process at facilities in Europe, USA and Asia. He also led the design and implementation of multiple up- and downstream processes in classical and single-use multiproduct mAb facilities around the world. These include a project in Asia to install one of the world's largest biopharm tangential flow filtration system. He is named inventor on several single-use and downstream patents and invented the first fully single-use crossflow system.
Jan holds an engineering diploma in Bioprocess Engineering from the Technical University of Braunschweig, Germany.
