Process Research & Development at Chemveda is where precision meets scalability, fueling our mission to transform discoveries into globally viable solutions.
Our Contract Research, Development and Manufacturing division (covering NCEs, APIs, Key Starting Materials (KSMs), Regulatory Starting Materials (RSMs), and Intermediates) encompasses the following:
We support a broad spectrum of delivery formats, ranging from gram-scale synthesis to multi-kilogram manufacturing, across the following modalities:
At Chemveda Lifesciences, the process development group adopts a delivery-oriented, risk-based approach to make critical decisions right from route scout to process development, and then manufacturing.
The key principles that outline each project here are:
The team is comprised of chemists, engineers, and process analysts with expertise in every phase of process research. The team works in coherence with all the other cross functional teams like analytical development, EHS, commercial sourcing, quality assurance and tech-transfer, etc. to ensure an on-time in full delivery.
We are equipped to follow both traditional and enhanced approaches by using ICH Q11 & 9 guidelines and implement QbD elements for finding the best operational ranges, wherever necessary. The team has expertise in solid state chemistry where we diligently optimize the process for the desired polymorph and particle size. Also, the team is well-versed with diversified requirements of phase I, II, and III, involving both scientific and regulatory aspects.
Our critical assessment for the selection of the route most suitable for commercial
manufacturing is based on the following MUST criteria:
In pre-clinical development, speed of delivery often takes precedence over having an optimal synthetic route. However, when taking the project to the clinic, an alternative synthetic route is required to deal with safety challenges and improving cost efficiency. Hence, Chemveda performs route scouting and route comparison studies to come up with more efficient synthetic route(s) involving reduced number of process steps, less expensive raw materials, safety aspects, etc. This is followed by route familiarization studies to identify the most appropriate one considering the delivery timelines and costs involved. We also specialize in route scouting of N-Acetylgalactosamine (GalNAc) ligands with multiple variations at GalNAc unit, spacer, DMTr and linkers like Succinate / Phosphoramidite for oligonucleotide conjugates and also for alpha anomer impurities synthesis.
Chemveda has a dedicated GLP lab and team to handle the batch releases by ensuring data integrity, regulatory compliance, and product quality.
At Chemveda, our Process R&D and Technology Services team will analyse the chemical processes and manufacturing plant operating procedures thoroughly performing a step-by-step review. The goal is to identify potential causes and evaluate the consequences of hazardous chemical releases. This process helps to identify a range of risks from equipment failures to human factors to improving safety, preventing downtime and protecting the surrounding environment.
Our Common methods for Process Hazard Analysis mainly include Failure Mode and Effect Analysis (FMEA), Hazard and Operability studies (HAZOPs) and “What-If” analyses.
Our experienced Technology Absorption & Transfer Team (TATT) undertakes transfer of technology from R&D to the manufacturing site or from your organization to Chemveda. The team has a proven track record of successfully taking lab processes to the manufacturing plant and delivering required quantities of chemical substances with desired specifications and within agreed delivery timelines.
We have an ably equipped kilo lab / manufacturing facility suitable to deliver multiple batches of up to kilogram scale under GMP/non-GMP conditions.
Chemveda will generate the regulatory relevant data from all concerned departments and provide documents to submit directly in eCTD submissions.
Chemveda has a fully-equipped kilo-lab / manufacturing facility that allows for rapid scale-ups, and development of scalable & robust chemical processes using advanced process methodologies to provide a quick supply of starting material, intermediate and API in the early phase of the development.
Key Aspects
Confirming the precise structure and authenticity of reference compounds with advanced analytical techniques (UV, IR, Mass, and NMR) to ensure consistency and accuracy in process development and scale up manufacturing.
