Affigenix is an emerging Bangalore based ISO 9001-2008 certified biotech company been in operation since 2013. The laboratory is equipped to do research in Biochemistry, Molecular biology, Microbiology and Cell biology. At present, we provide biosolution’s to biopharma companies and has also developed ~28 products (critical reagents) for drug manufacturing and diagnostic industries. As an innovative biotech company our mission is to develop innovative, quality and cost effective products suitable for use in life science industries and in low resource settings.
We have become a preferred service partner to dozen biopharma companies in India and have built up a reputation for professionalism, performance and productivity with-in four years of operations. We have assembled a team of 10 experienced scientists in the domain area and created a dynamic and challenging work environment to develop unique best-in-class reagents that are sensitive and specific to measure and monitor drugs/ anti-drug antibodies/diseases/pathogens etc. We believe that unique combination of market focused research project ideas, talents, experiences, perspectives and efficient and timely execution has given us an edge to responsibly deliver to our clients, investors, to grow the company and face any competitions. Since 2016, there is positive cash flow and we continue to grow organically with the revenue, government grant and family fund.
Current area of research in Biological sciences and Biotechnology:
The R & D facility is engaged in cutting edge research in areas such as antibody engineering, immuno and molecular diagnosis. For the short term, Affigenix is providing custom biosolutions to biopharma companies mainly involved in manufacturing of biologics such as clearance assay development (host cell protein, host cell DNA, Enzymes used in manufacturing process) and has also developed some viable low volume high value immunoassay products for biosimilar product development suitable for Pharmacokinetic, Immunogenicity and potency/NAb assay, biomarker discovery and personalized medicine. Long term plan is to discover and develop safe, pure and potent biologics to target complex diseases and develop novel diagnostic assays for human diseases.
Unique selling proposition:
Our USP is that we provide product and services to meet the regular science and ever changing regulatory science. We follow various ICH, FDA, EMA, Indian Guidelines in developing custom immuno, molecular and cell based assays for Biopharma companies. We also follow GLP and GMP in developing our niche products, in order to be accepted by international regulatory bodies.
From year 2014, we started generating revenues and we are adding and retaining customers on a monthly basis. We serve very niche market and understand scaling up is going to be slow due to small number of customer base and also tread the regulatory path. In addition adopting to the Business to Business model (B2B) and growing through R & D, we are in the process of venturing into Business to Customer model (B2C) to serve the diagnostic (patients).
Unmet market need:
Our “Made in India” products include.
Unique custom clearance assays with documentation suitable for GMP :
Trypsin, Carboxypeptidase, Entrokinase, Protein A, Single chain Insulin, Single chain Glargine, Triton X-100, free His tag, Mycoplasma, various Host cell proteins and various host cell DNA’s.
Pharmacokinetic (PK) assays, Immunogenicity assays, Neutralizing antibody assays for Biosimilar drug development.
We have extensive experience in developing PK and Immunogenicity assays for Hormones (Insulins), GCSF, PEG GCSF, biosimilar MAbs and many novel antibodies derived using phage display technology.
Animal health monitoring services, Design and oversee the comparative toxicity studies (RCGM, FDA and EMA).
Novel diagnostic products in the R & D stage include- two diabetes related product, one Urinary tract infection and one Sepsis diagnosis.
We figure out what our potential customers would need before they realize the need and provide what they want faster and in a more economical way. Typically we hand hold our clients and provide solutions in a more personal manner. We have limited number of customer base in India and we get business through our satisfied customers and through links from social media.