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For instance, a catalyst was developed or a customer a few years ago; it was eventually scaled to 750kg for the commercial production of Januvia (their diabetes drug). Leading Scientist Catalysis Solvias AG Continuous flow manufacturing has advantages over traditional batch production.

All big pharm and many biotechs use ligands and catalysts. It guarantees that the ideal "reactor" is available for each step in the process including the mixing of starting materials quickly, ensuring the correct stoichiometry everywhere, heating, cooling, addition of reagents, and removal of product.

In many instances this forces Phase II to become the defacto Phase III.

This often requires that the process and method employed during Phase II manufacture to be viable for validation or at the least validation readiness within a very short time frame.

It also provides for the use of hazardous chemicals and extreme reaction conditions.

Quality by Design (Qb D) is built into the system as there is a high level of process control and reproducibility.

It also can force initial commercial supply to be manufactured with less than optimized processes and methods.

There is development work that can be done early to be prepared for expedited review but this comes at a cost.

New environmental regulations in China are having an effect. Is the FDA doing enough to make the US an attractive location to renew our manufacturing legacy culture? These are the companies that are developing most of our new drugs. Suppliers: No presentations, just business cards, and a 4 minute chat, then visit the next table that matches your service offerings.Takeda Pharmaceuticals Medicinal Chemistry/Discovery Novartis Discovery & Pre-Clinical Development Discovery & Pre-Clinical Development Novartis Early-Mid Stage Clinical Development and Commercial API (process development plus Clinical supply) and Formulation Development and Clinical Manufacture.For DP Clinical Manufacture (supply) EMA Certification is a must for Novartis.Why should you contract the services of a second CMO during Clinical Stage Drug Development? President Drug Discovery Alliances & Tricia Scialla Pharmaceutical Outsourcing Professional (Formerly Bristol-Myers Squibb) During early and mid-stage development, a balance must be struck between planning for success and managing attrition of drug candidates, in order to be adequately prepared to move forward (in the event of success) or to cut losses (in the event of attrition). Principal SGL Chemistry Consulting Categorization of HPAPI molecules and how it differs across the industry based on sponsor or CMO and the data available; How to best avoid cross contamination looking at facility design and equipment including considerations for risk assessment when determining where to manufacture.Several recent cases underscore the importance of the added expense. How this is best done depends on many variables, including sponsor culture, budget, risk tolerance, and the science. Allison Vavala Associate Director, Business Development Helsinn We all realize that pharmaceutical services cannot be itemized like a widget.

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