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Contract R&D Synthesis
Our Focus is on Success at Each Stage of Development.
CLEARSYNTH efforts focus from the pre-clinical stage through to phase III and to the successful technology transfer to manufacturing locations throughout the world.
This focus of development includes:
- Synthetic scale-up development
- Analytical development and validation
- Stability test
- Gram to kilogram synthesis, both cGMP and non-GMP
- Technology transfer services Our attention to detail, with our focus to the program's ultimate success, enhances value at each step in the development process
Services for Ultimate Success.
Clearsynth services are applied at all stages of development. Clearsynth considers all issues related to:
- Routes and opportunities for early stage convergence
- Identification of strategic intermediates as candidates for nonGMP outsourcing
- Process optimization
- Raw material costs and commercial sources
- Related compounds and potential impurities
- Final isolations and methods
- Analytical method development and validation
- Specification development
- Stability of the final compound and intermediates
With the world's largest inventory of 359,000+ products and the largest database of certified analytical standards and reference chemicals, Clearsynth provides seamless support to accelerate your research and production.
Custom synthesis of organic compounds in milligram to kilogram quantities, is, and has been our core business since the foundation of Clearsynth. Our team of experienced Scientists has expertise in the custom synthesis of a wide range of small molecules like API, Stable Isotope Labeled Compounds, Chemical Intermediates, Drug Metabolites, Drug analogs, Analytical Standards, reference standards, pharmaceutical impurities, and new patentable scaffolds.
We offer a full range of services in custom organic synthesis, accomplishing complex, multi-step syntheses and "difficult to synthesize" chemistry projects. The majority of our chemists and analysts hold doctorates, with vast experience in synthetic organic chemistry. Our compounds are of high purity (>98%) and are well characterised through MS, HPLC and 1H-NMR. Other tests for characterization can be and are carried out on request.
Small Molecule Manufacturing
Chemically manufactured small molecules are the classic active drug substance that continues to be the "engine of growth" in the pharmaceutical industry. According to the IMS report small molecules share of the global oncology market had increased to 53% and biologics had declined to 47%.
Clearsynth offers custom synthesis services to comprehensive list of small molecules that includes active pharmaceutical ingredients, pharmaceutical intermediates, drug intermediates, drug metabolites, analytical standards, reference standards and certified reference materials, chemical intermediates, chemical standards, and pharmaceutical impurities.
We can synthesize a wide variety of fine chemicals and compounds for small molecule drug discovery from milligram to multi-kilo scale. Custom synthesis of small molecules and fine chemicals is central to small molecule screening and small molecule drug development.
Scientists in our modern analytical labs routinely design processes to produce materials in excess of 98% HPLC purity. We can easily adapt to meet your specific quality specifications. Whether your project requires milligram quantities or kilogram quantities, we can meet your needs. We handle challenging synthesis projects and are committed to responsiveness.
Delivery of a drug candidate from the discovery stage to clinical phases requires a robust and well-defined process research and development plan. As per requirements, Clearsynth can either develop new synthetic routes from the beginning or modify and optimize processes provided by customers.
Clearsynth Development scientists design novel or improved methods and processes suitable for medium to large-scale production. Our scientists possess expertise in a broad range of structural classes of molecules and are able to address a wide variety of chemical synthesis and production problems.
Process Studies Include
- Synthetic route scouting (Identify problems, non-compatible sequence and feasibility)
- Discovery and development of new process methodologies (new synthetic routes & optimization)
- Impurity synthesis & characterization
- Analytical Development
- Technology transfer and process justification document
The Technology Transfer report prepared by Clearsynth will be essential for successful transfer ofdrug candidates from discovery to clinical phase.
Full-time-equivalent (FTE) - a flat monthly rate which can be cost effective for larger scope projects
FTE assignments at Clearsynth are conducted by Ph.D. scientist working full time on the project. we provide the client with a project team dedicated to the client's needs for a specified period of time at a fixed rate per FTE and generally involve complex or longer-term projects. It is the most cost-effective & reliable way forward, in accelerating drug discovery as the collaboration includes providing consistent and reliable laboratory service, timely project startup and alteration to project is quick without the need to adjust a work order.
Project steps for FTE service
- Send us your projects requirements at firstname.lastname@example.org
- We will assemble a dedicated research team to accomplish your research goals
- Under your supervision and management, the project starts
- You will have timely project updates, meetings, or reports, as needed
- Final report and product delivery
Code of Conduct
Contractually guarantee that,
- We will take comprehensive measure to safeguard and ensure the confidentiality of all projects
- We will not take up any similar projects for any other client for a mutually agreed period of time.
- We do not accept any contracts that would affect or conflict current work in hand of our clients
- We will not sell any products that came from contractual research without the client consent