Process Development
We offer comprehensive process development solutions to identify and develop the most optimal process for your compounds including APIs, advanced intermediates, and Key Starting Materials (KSM). We keep customer's needs at the center of our planning. We understand our customer's requirements at every stage of the journey to the clinic. To meet these varying requirements, we follow a phase-appropriate process develop.
Early Stage: At an early stage, our focus is to accelerate the journey for the clinic to our customers through science and innovation. Our way of execution and processes ensures agility without compromising on safety, quality and sustainability. The focus at this stage is to ensure faster turnaround time. Leveraging our vast experience in chemistry & process development, we have a unique advantage of identifying the most important process parameters.To minimize the risk of failure at the GMP scale, we propose to perform one demonstration batch at our non-GMP kilo lab available at our development facilities.
Late Stage: We have a legacy of developing 500+ molecules, several of which are in the commercial phase in highly regulated markets like the USA, Europe, Japan, etc. We follow a very robust & systematic approach to process development. Our vast manufacturing footprint allows us the flexibility to choose from a variety of unit operations suitable for product manufacturing. We follow a QbD-based approach for process development and the first step is to identify the key starting material and process parameters that impact the specification of the product. Our supply chain team helps in sourcing the raw materials with desired quality in time. For each stage, we plan a sequence of a well-designed set of experiments to understand and establish the sensitivity of important parameters on quality. We typically run 15-20 experiments per stage to arrive at the most optimum process. Post completion of these studies, three consecutive lab confirmatory batches will be performed to establish the yield & quality of the product. The processes which are identified to be challenging for scale-up, are studied in our intermediate-scale non-GMP setup at our development facilities, before moving to large-scale manufacturing.
Analytical Development
Our Analytical Development team provides various services, including method development, validation, and transfer. The team conducts comprehensive analyses of small molecules utilizing a wide array of advanced spectroscopic, chromatographic, and physicochemical techniques. We provide personalized solutions for every client project, including designing customized analytical protocols, developing, and validating new methods, and conducting thorough characterization, impurity isolation and identification. Our comprehensive services are dedicated to ensuring the utmost quality, safety, and efficacy.
▪ Method development ▪ Validation studies according to ICH guidelines ▪ Purity assay analysis ▪ Physical and chemical tests ▪ Q-NMR analysis ▪ Residual solvent analysis ▪ Quantification of solvent impurities ▪ Analytical method transfer
Scale up
The ultimate goal of custom synthesis is to scale up or go from producing gram quantities in a laboratory to producing commercial APIs from kilogram to ton quantities in a pilot or commercial scale plant, all while maintaining high quality and reproducibility at the lowest cost. With scale up, the efficiency of the custom API synthesis process becomes increasingly important. In the end, the goal is to have viable process research that produces the same results day after day, creating a reliable, cost-effective supply chain for drug products. For successful scale up timing is everything. Scale up is a balancing act, and requires judgment calls to know when a process is ready to move to the next level. Furthermore, it is essential that the drug substance manufacturing process is scalable from a technical and economic viewpoint. Our synthetic organic chemists continuously seek such advances to help improve yield, purity, and stereoselectivity of intermediates and APIs and accelerate scale-up processes from laboratory scales to pilot scales, and ultimately the commercial production scale.
Technology Transfer
Technology transfer of API from lab to plant is a very critical process for successful API delivery to the client. Diligent planning and execution are required right from selecting plant and equipment, obtaining manufacturing slots, reviewing product development and ensuring the right documentation is delivered on time. At Fred, we have a cross-functional team of analysts, chemists, engineers and quality specialists who lead the process of technology transfer. We have extensive experience of scaling up 100+ projects and 500+ process steps. Our technology transfer procedure from the laboratory to the respective manufacturing facility includes:
▪ Raw material list along with specifications and method of analysis
▪ Optimization report or finalized process for the manufacturing
▪ Holding study data of reaction mass, wet or dry intermediates
▪ Recovery or reuse of solvent (as applicable) Reprocessing or rework procedures (as applicable)
▪ Details of analytical methods for in-process controls, intermediates and final compound reference standards
▪ Batch Production Records (BPR)
▪ Process flow diagram
▪ Equipment justification reports
▪ Details of process safety evaluation and the recommendations
▪ Based on the technology transfer document batch production record to be generated prior to manufacturing start up