SubscribeGrowing competition compels pharmaceutical companies to launch new and effective drug substances more quickly by optimising their pipelines and streamlining their chemical development programs.
At the same time, many of the small to medium organizations feel they lack sufficient financial resources to invest early-on in the development of a robust, cost-efficient, and safe manufacturing process. These competing pressures exist in an environment of rising development costs and increasing regulatory requirements (cGMP).
During chemical development, Process Research and Development plays a central role to ensure that drug substances are available in the required quantities and quality in time to start pre-clinical and clinical studies and to provide a basis for future manufacturing processes. This puts Process R&D on the critical path of the chemical development process, particularly in the early stages.
The main reason for delays in the supply of the required amounts of drug substance is not a lack of production capacity but unforeseen or unresolved manufacturing problems which occur at a critical step in the process leading to expensive product rework and rescheduling of production timelines. Problems are inevitable even with good planning but failure to meet ambitious time-schedules can be minimized by choosing a development partner with outstanding problem solving capabilities.
Solvias, as former part of a global pharmaceutical company, is an independent organization with many years of chemical development experience and a broad technology base. We offer our customers comprehensive support and guidance to steer their project successfully through all phases of chemical development. Solvias offers a unique integrated approach to Process R&D for complex active pharmaceutical ingredients.
This begins with a thorough review and evaluation of the current manufacturing process followed by targeted process optimization/process redesign. Specialized techniques such as asymmetric homogeneous catalysis, heterogeneous hydrogennation, carbonylation, and selective fluorination chemistry are employed, where applicable, to reduce manufacturing costs and improve process reliability.
The result is the development of an optimized synthesis suitable for scale-up to multi-kilogram quantities. Our objective is provide customers with a robust process that can readily be transferred to a CMO for industrial-scale production without problems. Solid state investigations including salt selection, polymorphism screening, and crystallization optimization programs enable customers to prepare the optimal solid form of a drug substance with well-defined properties for manufacture of the corresponding drug product.
Chemical analysis specialists at Solvias develop and validate analytical methods for release testing and in-process control, characterize synthesis intermediates and by-products, prepare and qualify analytical reference standards, and perform standardized stability programs (cGMP, ICH),
Solvias can also provide comprehensive production management services to our customers that includes the transfer of the completed manufacturing process and analytical methods to one or more qualified custom manufacturers and ongoing monitoring of the production campaign. Solvias can also perform final release testing of the drug substance.
Finally, Solvias' legal department performs patent assessment and patent-filing support to provide the client with full intellectual property coverage.
The integrated approach to Process R&D at Solvias provides our clients with the tools to design a robust, scaleable, and cost-efficient manufacturing process, avoiding unexpected surprises and ensuring that product can be prepared on-time and on-budget.