Process Development and Manufacturing – Reliance Life Sciences.

Reliance Life Sciences (RLS) is part of The Reliance Group, India’s largest private sector company with over $67 Billion in annual revenue. RLS was formed in 2002 and then moved into a state-of-the-art facility and campus in a suburb of Mumbai in 2005. RLS has grown tremendously since then. RLS is involved with all aspects of pharmaceutical manufacturing and has its own CRO providing non-clinical and clinical trials development and support services for RLS products and products under development by large and small pharmaceutical and biotechnology companies around the world. RLS is an integrated life science-oriented company with over 1,000 employees and over 30 products approved to market and sell in India and other markets around the world. Many of the approved products are biologic drugs manufactured by recombinant DNA technology – products like alpha- and beta-interferon, erythropoietin (EPO), filgrastim (G-CSF), HCG, FSH and TPA. The Company is now focused on production of a long pipeline of “biosimilar biologics” including the monoclonal antibodies licensed exclusive to Anew Biotechnology, Inc.

The partnership is symbiotic and important to both companies – Anew and RLS. RLS provides a large body of quality data that is leveraged by Anew to enable starting late-stage clinical trials required of a BLA or a biosimilars (351(k)) application for market approval in our territories, saving Anew many millions of dollars in development costs and many years of effort. The Anew territories include the major markets – U.S., European countries, and Japan, and the growing or emerging markets of Mexico, Latin American countries, S. Korea, Israel, Australia and New Zealand, and other markets on a case-by-case basis. The advantage to RLS is that Anew buys and RLS supplies bulk drug substance to Anew on an exclusive basis, and RLS receives significant developmental milestone payments and a royalty on sales of the products in our territories. This is a “win-win” situation for both companies.


The RLS Campus in Navi Mumbai, India.

The Comparability Testing Exercise – Drug Substance and Drug Product

Follow-on Biologics and biosimilars will require a well thought-out “comparability exercise” on a product-by-product basis, comparing the Innovator’s product to the Company’s product. The foundations of comparative analytical, biochemical, in vitro and in vivo, and human testing will be reproduced for each biologic molecule under development. Most of this comparative testing exercise will have been completed by our partner, RLS, in advance of the “hand off” of testing data to Anew Biotech. Drug Substance will be thoroughly analyzed per all of the requirements and guidance documents set forth by regulatory agencies and by Innovators, and by competitors in the field of biosimilars.

Analytical, biochemical and cell-based analysis is the foundation on which the biosimilar industry is based. These data must show a high degree of similarity before a candidate biosimilar can move to animal and human clinical testing. Many companies have invested in building up in-house capabilities that combine a state-of-the-art analytical laboratory with some of the world’s finest analytical protein chemists. We have the tools and skills to understand the complex structure of these therapeutic products. Other companies such as Anew Biotech rely on expertise and experts founding companies that provide all of the testing services required to complete the comparability exercise. These contract research organizations (CROs) provide a standardized comparability test system with the appropriate “controls” (Innovator products) to:

  • Analyze and identify the chemical amino acids and 3-D structure of the protein and variants – testing data on rituximab and trastuzumab show identical amino acid sequences and glycoprotein composition compared to the commercial products;
  • Evaluate the comparability of the profiles of the primary, secondary and higher order structure, size variants, charge heterogeneity, glycosylation, and post-transitional modifications, such as oxidation, deamidation, isomerization and N-terminal modifications, between our candidates and the Innovator’s reference products – testing shows identical higher order structure.
  • Evaluate and determine the effects of any post-translational modifications such as atypical glycosylation, using sophisticated mass spectrometry and associated techniques – done – bioidentical;
  • Conduct biophysical analysis to understand the solution properties of the proteins, the immunochemistry, ligand and cell-binding characteristics, and the identification of potential immunogenic forms such as sub-visible particles and immunogenic epitopes – nearly identical binding plots and cell killing data; and
  • Using validated standard operating procedures (SOPs), determine in vitro activity and comparative potency, and complete in vivo animal studies of comparative efficacy and toxicity to prove similarity of the Innovator’s molecule and Anew Biotech’s molecule – non-clinical and clinical studies show nearly identical results with clinical efficacy results within 2% of the innovator product.

Other Contract Research Organizations (CROs)

CROs perform clinical trials at hundreds of “sites” (hospitals and clinics) around the world and they capture and analyze clinical trial data for their clients. CROs also are analytical laboratories conducting product characterization for their clients. Anew relies on pre-qualified CROs with a successful track-record and highly experienced professionals within those organizations. Using the most advanced instrumentation and techniques, Anew can construct detailed “fingerprints” of the Innovator compound that our Team will present to the regulatory authorities to provide the security of progressing to randomized Phase III human studies and commercialization. As regulatory agencies around the world align on the requirements for follow-on biologics and biosimilars, we believe that it is now possible to harmonize the regulatory and clinical development strategy to meet the requirements of multiple agencies, particularly the U.S., Canada and Europe.


Photo of Scans being analyzed Doctor