Process research and timely supply of active pharmaceutical ingredients (API) are vital elements of successful drug discovery and development programs. Whether a promising drug candidate is found through collaboration with deCODE chemistry and deCODE biostructures or through a client's own drug discovery efforts, our process chemistry team has the expertise to solve scalability issues and produce API of sufficient quality and quantity for use in pre-clinical or clinical studies. Early engagement of deCODE's process chemistry team can serve to decrease timelines and associated expenses occurring after lead optimization and prior to initiating IND-directed development. Once a drug progresses beyond Phase II, deCODE chemistry's team can assist with successful technology transfer to larger-scale manufacturing facilities. Our process chemistry expertise and facilities serve a broad range of needs and offer the capacity and flexibility needed for successful drug development.
Custom Synthesis of API and Intermediates deCODE chemistry understands the importance of success at every phase of clinical study. From the earliest stages of chemical development and synthesis, deCODE chemistry strives to maintain a critical balance of quality and rapid delivery. Our facilities and quality systems are designed for production of API for use in pre-clinical studies through Phase II human clinical trials. Our chemists routinely perform rapid synthesis and scale-up for development candidates, intermediates, analytical reference standards, and active pharmaceutical ingredients. Materials can be produced in support of client programs in gram to multi-kilogram quantities. The laboratories at deCODE chemistry are designed for maximum flexibility and are fully equipped to handle a broad range of chemical reactions.
Process Optimization Once a small molecule is identified as a promising clinical candidate, deCODE chemistry's expertise in process research and optimization can be utilized to provide a safe, scalable, efficient, and economical synthetic route. Our process chemistry team works closely with clients to understand their products and maintains diligent communication as research progresses to advise on results and collaborate on solutions. The goal of process development research projects at deCODE chemistry is to help our clients achieve the advantage of entering pre-clinical and clinical studies using a synthetic route with a reduced number of steps, reduced consumption of raw materials, and optimal yields.
As your program progresses, our team will work diligently with you to fully understand your chemical process. Through a lab pre-qualification program, our process chemists can design an in-depth evaluation of your chemical process, identify the Critical Process Parameters, and provide the necessary operating ranges in order to meet the required specifications to ensure the safety of the drug. This information is invaluable as your production needs grow ever larger, and your product moves closer toward NDA filing.
cGMP Production Quality issues can be costly and time-consuming. deCODE chemistry employs a team of professionals experienced in cGMP regulated production of API to help clients avoid delays in their clinical studies. Compliance and quality are vigilantly upheld in deCODE's cGMP facilities. Housed in its state-of-the-art facilities in Woodridge, IL, deCODE chemistry operates three production laboratories, each with the capacity to manufacture 5-10 kg of API. These laboratories are operated under a Class 10,000 environment and are modular in nature, to allow for maximum flexibility. Our cGMP facilities regularly undergo internal and external auditing to ensure compliance and assess efficiency.
Polymorph and Solvate Screening In many cases, a drug compound may exhibit more than one crystalline form. Varying crystalline forms, or polymorphs, may exhibit dramatically different stability, solubility and bioavailability characteristics. deCODE chemistry has developed an innovative and thorough experimental design for polymorph screening, as well as analytical techniques for polymorph determination. These services assist clients in identifying the solid state forms of compounds and then establishing which are the most stable for further study. Once the most stable polymorphic forms are determined, our process chemists can develop a controlled crystallization process to produce the desired polymorph with dependable results.
