Join Lonza and Life Science Leader for a 60-minute webinar on Developability: Reducing the Risk of Failure of Biotherapeutic Candidates
Date: Wednesday, November 18, 2015
Time: 11:00 am EST
To register, please click here: http://bit.ly/1WrDik1
It is estimated that only one out of every 1,000 preclinical candidates reaches the commercial market. The ability to assess the “developability” of a therapeutic candidate in late discovery through clinical phases of development can be an extremely powerful tool to enhance the chance of clinical success. Screening of potential candidates in the discovery process will help to reduce costs, risk (attrition) and overall development time. Being able to assess the manufacturability and safety of the drug candidate, before large investments are made, allows companies to focus on the most promising candidate and maximize R&D spending.
A number of in silico methods can be used to evaluate protein sequence and structure in order to provide information on potential manufacturability issues such as aggregation, deamidation, isomerisation and glycosylation. In order to perform continued and more detailed developability assessments, it is essential to rapidly produce material representative of the final product using regulatory approved expression systems.
This webinar will present methodologies behind the following:
- Manufacturability Assessment of deamidation, stability, cleavage, post-translational modifications which can impact productivity and product quality
- Aggregation prediction for monoclonal antibodies
- Mitigation of risk via protein re-engineering supported by Product expression
- Safety Assessment using Lonza’s proprietary Epibase™ In silico Screening tool to identify potential T-cell epitopes in biotherapeutics that may trigger immune reactions
Case studies will be presented where in silico and in vitro tools have been applied to mitigate product risk.