If you can draw it, we can create it.Custom synthesis of organic compounds in milligram to kilogram quantities, is, and has been our core business since the foundation of BioOrganics. Our team of experienced Scientists led by Dr. Hulikal 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. Our compounds are of high purity (>98%) and are well characterised through MS, HPLC and NMR.
Our Analytical Services team consists of highly skilled scientists with expertise in modern analytical techniques, supported by state-of-the-art instruments. This team has extensive experience in developing, optimizing and validating methods. Our reliable analytical methods and techniques ensure that the quality of the products that we have produced is of the highest standards.
Services offered include:
Certification of Analytical Reference Standards via full Chemical Analysis
NMR Analysis
Mass Spectrometry Analysis
IR Analysis
Analytical Method Development and Validation
Isolation and Characterization of Impurities and Degradation Products
Resolution of Chiral Compounds
Melting Point
HPLC-DAD, HPLC-PDA, HPLC/MS/MS
Water Content by Karl Fischer
Residual Solvent Content by 1H-NMR or GC-Headspace
Our Focus is on Success at Each Stage of Development. BioOrganics 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 everything from synthetic scale-up development, analytical development and validation, stability tests, gram to kilogram synthesis to both cGMP and non-GMP. Our attention to detail, with our focus to the program's ultimate success, enhances value at each step in the development process. Our services within this focus extends to:
Routes and opportunities for early stage convergence
Identification of strategic intermediates as candidates for nonGMP outsourcing
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%. BioOrganics 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.
Full-time-equivalent (FTE) - a flat monthly rate which can be cost effective for larger scope projects FTE assignments at BioOrganics 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.
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, BioOrganics can either develop new synthetic routes from the beginning or modify and optimize processes provided by customers. BioOrganics 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 BioOrganics will be essential for successful transfer of drug candidates from discovery to clinical phase.
