Anthem Bio Pharma Private Limited

Anthem offers custom synthesis /contract manufacturing services in the areas of preclinical and clinical research, chemical / pharmaceutical development and lead optimization /pro-drug development, agro-chemicals, nutritional supplements, cosmetics etc. Anthem has vast experience in synthesis of complex raw materials, registered starting materials, active ingredients and drug substances in multi-kilogram scale.

Many clients have utilized Anthem's custom molecular biology service that ranges from cloning and expression, to protein purification. Our scientists can help you custom design solutions based on our expertise, and walk you through the various steps. Our dedicated project managers will communicate in a timely manner the progress of your project. We have successfully executed many projects that encompass cDNA synthesis, site directed mutagenesis, cloning, expression and protein purifications in an economically viable manner. 

Natural products are an attractive source of diverse functionalities that exhibit potent biological activities and many new drugs have been designed based on natural products. 

As the demand for new chemical entities (NCE) towards different therapeutic areas is ever growing, virtual libraries derived from natural product-like scaffolds would be an ideal platform to identify druggable compounds.

Anthem has developed a novel idea of generating scaffolds inspired by natural products. The core structure of natural products is modified by introduction of drug-like functionality, removal of toxicophores and so on. Subsequently suitable functional groups are added to the core structure to generate scaffolds which could be amenable to library generation of novel compounds. These scaffolds are also carefully chosen based on their synthetic feasibility.

This unique concept of building scaffolds derived from natural product has provided access to a diverse collection of virtual library compounds. This collection of compounds would serve as an ideal starting point for any high throughput screening (HTS) program involving search for pharmacologically active molecules. Currently Anthem has a collection of about 100,000 virtual library compounds derived from natural products. These are available to clients on mutually agreed terms 

Process Chemistry is one of the core competencies of Anthem .The Chemical development team has nearly 70 scientists, experienced in advancing lead molecules from bench to commercial scale production. Anthem is an ideal partner for rapid development, to produce drug substances for pre-clinical trials and to establish robust manufacturing processes. In past six years, Anthem has developed commercial processes for about 60 molecules which include complex raw materials, registered starting materials and drug substances. The Chemical development team is well versed with generating all required data including process justification for regulatory filings.

Philosophy and expertise:
A glimpse of our expertise is listed below 

• Route scouting and feasibility study
• Establishment of design- enhanced QbD(Quality by Design) approach (a systematic understanding of process parameters for pharmaceutical actives and intermediates)
• Investigative approaches to chemical development and optimisation using parallel synthesizer and jacketed glass reactor, focused on robustness
• Ability to examine process safety (by process hazard risk assessment using DSC, RCe1etc.)
• Chemical engineering concepts, particularly mixing, heat transfer and process control are studied during the course of development
• Establishment of in-process controls
• Development of processes which are scalable, safe and environment friendly
• Process optimization focusing on optimum reaction conditions and reagent quantities, minimum cycle time, maximum concentrations and telescoping of steps
• Hold time studies, establishment of parameter boundaries and challenge tests
• Study and determination of root cause of impurity formation and fate of impurities
• Analytical development in parallel
• Separation science expertise for isolation and characterization of impurities and preparation of impurity standards
• Tech transfer and process justification documentation
• IND/DMF support

Anthem's medicinal chemistry team is a group of > 25 scientists with several years of experience in the areas of cardiovascular, CNS, cancer, inflammation, diabetes and infections. We provide services for various stages of drug discovery such as hit identification, hit to lead, lead optimization, salt selections, pro-drugs for lead molecules, synthesis of novel polymorphs for the lead molecule and continuous IP assessment at all the stages. 

Strategy for hit identification:

• Synthesis of 1-2 reference compounds if known in literature
• Assessment of IP space with the help of proven search engine such as SciFinder
• Generate virtual library of >1000 compounds with the help of molecular modeling and synthesis of best docked molecules
• If the reference compound is known for the particular target, based on fast follower approach, we can design and synthesize novel compounds to identify quick hits or leads
• Novel molecules for the target of interest can be synthesized from the available virtual natural product inspired compound bank, available at Anthem

Anthem Biosciences provides expertise in design and planning, conducting studies reporting data to our clients as per the guidelines of regulatory agencies. We have expertise in performing in-vitro, and rodent and non-rodent (acute through chronic) toxicology studies. 

TOXICOLOGYGENETIC TOXICITY STUDIES

• Ames test
• Chromosomal aberration test
• Micronucleus test
• Mouse Lymphoma assay

The assay biology group at Anthem Biosciences is dedicated to serve our clients perform in vitro biochemical and cellular studies in order to evaluate potency, and other in vitro pharmacology parameters of their compounds. We have developed and customized assays to validate drug targets, as well as screen small molecule drugs for various therapeutic areas including cancer, inflammatory diseases, metabolic disorders, infections (virus, bacterial and fungal), neurodegenerative ailments, and genetic disorders. We have ongoing projects in the development of biologics. We are continuously adding to the list of assays that we can perform. If you do not see the assay that you need below, please get in touch with us to get the current list, or our experts could provide customized solutions for your research needs. 

ASSAY BIOLOGY (examples)Enzymatic assays

• Ant ioxidants (ORAC)
• NAD/NADH
• Nitric oxide synthesis
• Cox and Lox
• Prostaglandins
• Kinase assays
• Epoxide inhibition assays
• Hydrolase inhibition assays
• NF-kb activation assay (reporter based)
• HDAC assay