The process chemist in the drug development industry has a difficult job: provide more drug substance material quickly and reliably while also reducing costs of development. Within weeks he/she may have to establish a route to create grams to kilograms of a drug candidate for toxicology tests and clinical trials. Key considerations are controlling impurities such as elemental metals and potential genotoxins. If the drug candidate progresses, the process chemist may focus on the preparation of the optimal final form of the potential active pharmaceutical ingredient (API), and the generation of a practical route that can be used for scale-up to commercial quantities.
Join fellow process chemists working in early process research and development of APIs to share best practices and learn from one another in developing efficient ‘fit for purpose’ routes of synthesis for small molecule drug candidates. For the first time Cambridge Healthtech Institute’s ‘Process Chemistry’ event, will be part of our larger World Pharma Congress multi-track event. The day and a half process chemistry meeting will be preceded by a Formulations-focused meeting. We are striving for a few overlapping talks between the two meetings that focus on issues of interest to both, process chemists and formulation scientists. For example, strategies and technologies for improving API and excipient stability, or discussions on co-crystals, polymorphisms and impurity formation are potential cross-meeting topics. If you are submitting a proposal for a podium presentation and your talk would be appropriate for a shared formulation/process chemistry session, please indicate.
Topics will include, but are not limited to:
- Route scouting: considerations for making early material and for manufacturing
- Defining design space, including DoE
- Continuous flow chemistry for safety, quality, throughput and economics
- Process Analytical Technology (PAT)
- Process development guided by green chemistry, e.g., E-factors
- Change control and when to communicate changes to regulators
- Critical process parameters (for QbD)
- Strategies for dealing with genotoxic impurities
- Amorphous API dispersions: a growing trend?
- Creating co-crystals
- Polymorphs in selecting final forms and in formulation
Scientists who wish to present their knowledge and expertise to their colleagues as a podium or poster presentation are asked to submit an abstract.
Click here to submit a speaking proposal. Remember to specify the conference that you are interested in and please provide your full contact information.
Visit www.worldpharmacongress.com to register for a very special early-bird discounted rate.
The deadline for submission is November 1, 2013.
All proposals are subject to review by the Scientific Advisory Committee to ensure the highest quality of the conference program. Please note that due to limited speaking slots, preference is given to pharmaceutical and biotech companies, regulators and those from academia. Additionally, vendors/consultants who provide products and services to these biopharmaceutical companies are offered opportunities for podium presentation slots based on a variety of Corporate Sponsorships.
For questions or suggestions about the meeting, please contact:
Anjani Shah, Ph.D.
Cambridge Healthtech Institute
T: (+1) 917-509-9109
For sponsorship and exhibit sales information including sponsored podium presentations, contact:
Manager, Business Development
Cambridge Healthtech Institute
Phone: (+1) 781-972-5431