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At ARSI Canada, we have more than 50 years of cumulative experience in providing drug development services.
We Offer:
Custom Synthesis of Drug Substance (API Intermediates) and Regulatory Starting Materials
We offer custom synthesis or contract research of small to large-scale drug substances (API intermediates) and regulatory starting material. We provide R&D grade synthesis of these materials based on your project requirements.
ARSI Canada's R&D facility at Mississauga can synthesize mg to kg scale materials for your early development needs and pre-clinical trials.
Besides this, our GMP bulk manufacturing facility in Bangladesh has six 3000L reactors, multiple centrifuge machines, over 250 Kg fluid bed dryers, and a yearly capacity of 250 MT to produce GMP APIs & non-GMP intermediates.
Drug Substance (API intermediate) Synthesis
R&D grade API synthesis (API Intermediates) is the process of synthesizing active pharmaceutical ingredients (APIs) by maintaining good laboratory standards. Non-GMP API synthesis is typically used for research and development when the API is not yet ready for production or commercialization. Non-GMP API synthesis can also produce small batches of API for clinical trials.
Route Development
Route development is a process of identifying the most economical and efficient method of synthesizing a desired molecule. This typically involves evaluating different chemical pathways and selecting the best route based on cost, safety, and yield considerations. Additionally, route development often involves the evaluation of various catalysts, reagents, and solvents to maximize the desired outcome of the synthesis.
Our experiments chemists can help you to find the best possible routes for your target compound. We can help you to optimize your process, reduce the steps, and find the right solid forms with your many years of industrial experience.
Lead Optimization
Lead optimization is a process of optimizing the production of active pharmaceutical ingredients (APIs) to meet the desired performance criteria. This includes optimizing the process parameters and reducing the costs associated with API production. It also involves reducing the time needed for API production, improving the quality of the API, and ensuring the API meets the necessary regulatory requirements. Lead optimization also includes developing strategies for API scale-up, improving API efficiency, and ensuring the API is stable and safe.
At ARSI Canada, we have experienced chemists with many years of experience working in API industries. They can help you to find the best solutions for your project.
Scale-up
Scaling up of a process involves the production of an active pharmaceutical ingredient (API) from laboratory to commercial scale. This involves transferring the process from laboratory-scale to pilot-plant scale and finally to commercial-scale production. It is a crucial step in the drug development process and requires careful consideration of the process parameters and scale-up factors to ensure product quality and consistency. The scale-up process includes the evaluation of the process feasibility and optimization of operating parameters, equipment design and selection, raw material selection, and process validation.
Our chemists with more than 50 years of industrial experience of process scale-up are ready to help your scale-up your API from laboratory scale to commercial scale form mg to kgs to matric tons.
Method development
Method development is the process of developing, optimizing, and validating analytical methods used to measure and characterize a drug compound. It involves selecting appropriate sample preparation steps, chromatographic conditions, and detection methods for the compound in question.
A good robust method of development is critical for its life cycle management. Our experienced method development chemists can help you develop methods using DoE concepts and meet regulatory agencies’ requirements, and fi the traditional one-step-at-a-time approach based on your requirement. We guarantee the best possible solutions for your methods.
Methods must be validated to ensure that they are accurate, precise, repeatable, reproducible, and meet regulatory agencies’ requirements and fits for its purpose.
The methods must also be optimized to ensure efficiency and provide the most relevant information about the drug compound.
We offer phase-appropriate method development and validation for any kind of tests.
Tech Transfer
Tech transfer is the process of transferring technology from one party to another. The process typically involves transferring knowledge, processes and/or materials from one party to another.
It involves transferring the knowledge, processes and materials necessary to take a drug from concept to clinical testing. This includes everything from synthesizing and testing compounds to clinical trial design to manufacturing and delivering the final drug product.
ARSI can help you in developing a process in its R&D facility and then transfer that to any part of the world for its implementation from laboratory scale to commercial scale. We will help you with any support you need, from documentation to implementation of the process.
Process Development and Engineering Batch
Safety is paramount for scaling up a process. Our SMEs primarily focus on process safety and scale-down (fit the process in the plant), guide the development chemist to implement the QbD approach in the process to learn the process.
We can use the DoE approach to develop a reliable, robust, fit-for-plant process or improve the existing process to reduce overall product analysis time and be more cost-effective. Our receptive and collaborative approach is especially beneficial when working with challenging processes. Our experts are highly competent in process transfer from mg to gram and gram to Kilo scale. Process development includes:
- Review of process safety
- Process design for seamless operation
- Process mapping to simplify the process flow
- Equipment modification based on process requirement
- IQ, OQ, DQ, and PQ for new equipment
- Engineering or Demo Batch