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In the life-cycle of biopharmaceuticals, manufacturing change is unavoidable. Owing to the complex nature of the biopharmaceutical product, physicochemical and functional changes occur which can affect both safety and efficacy. This three-track event looks at manufacturing change and its potential consequences, and industry experiences with handling this and harnessing it to advantage.
Protein Scale-Up, Process Change & Technology Transfer explores strategies to successfully reach larger scale, while examining economic drivers, outsourcing and platform technologies, in light of the regulatory environment that governs change implementation. The meeting will include a focus on how larger companies employ continuous process improvements to reduce waste and increase downstream efficiencies. Case studies will illustrate how state-of-the-art methods are overcoming protein challenges in the quest to achieve scale.
Post-translational Modifications looks at the potential impact of PTMs on product quality and function. Biopharmaceuticals are subject to post-translational modifications at every step of development and manufacturing, and analytical methods for detecting these PTMs are improving by leaps and bounds. This track will provide case studies on physicochemical analysis and functional testing of PTMs, explore how PTM analyses can be used to support manufacturing, and how PTMs can be harnessed for product optimization, for example in antibody engineering, clone selection, and development of formulation. Regulatory perspectives in terms of new guidance, regulatory experience and precedence will be included.
Biologics are constantly subject to change implementation, which necessitates physicochemical and biological comparability studies. The industry needs to ensure safety and efficacy, as well as regulatory approval, but does not wish to be over zealous. Comparability at all Stages of Development will present technological advances and provide industry case studies of physicochemical analyses, bioassays and pre-clinical and clinical studies for comparability after various types of change implementation. It will provide advice on developing a well thought-out risk assessment strategy offering huge financial advantage to the investigator, together with presentations from the European and US regulatory authorities and industry experts experienced in regulatory interaction.
For more information, please contact:
Nicole Lyscom, Ph.D.
Conference Producer
Cambridge Healthtech Institute
Phone: +44 7791 866 489
Email: nlyscom@healthtech.com
Mary Ruberry
Conference Producer
Cambridge Healthtech Institute
Phone: +1 781 972 5421
Email: mruberry@healthtech.com
For sponsorship information, please contact:
Jon Stroup
Manager, Business Development
Cambridge Healthtech Institute
Phone: +1 781 972 5483
Email: jstroup@healthtech.com
For marketing and media partnerships, please contact:
Rich Handy
Senior Director of Marketing
Cambridge Healthtech Institute
Phone: +1 781 972 5456
Email: rhandy@healthtech.com