In the Indian Union Budget 2026–2027, the finance minister has introduced Biopharma SHAKTI (Strategy for Healthcare Advancement through Knowledge, Technology, and Innovation). With a huge investment of ₹10,000 crore, Biopharma SHAKTI is a historic change in the healthcare industry an India is now becoming a global leader in Biosimilars, surpassing even the generic market.
The technical focus is now shifted on the “process” as industries are shifts towards high-value biologics for diseases like autoimmune disorders, diabetes, and cancer. At TM Media we understand in the biologics industry the process is the product and that’s why we offer the fundamental products of process under our Biological Media Bases category. Biological Media Bases or Culture Media Ingredients plays an important role in transforming the scientific blueprints into treatments that can save lives.
Biosimilar as it names suggests it is a biological product that is very similar to the already approved reference biologic. Biosimilars are different from chemically produced generic medications as they are produced in a living system. A Biosimilar must exhibit no clinically significant variations in potency, safety, or purity and this can only be achieved by a high degree of control over the cellular or microbial environment.
The process of Biosimilars production is a microbiological marathon that needs advanced methods to guarantee that that final product is similar to the fingerprint of reference biologic.
The process mainly involves three stages:
This is the initial stage, in this the target protein is first inserted into a host cell, usually Chinese Hamster Ovary (CHO) cells or microbial systems like E. coli.
Nowadays, manufacturers employ the Multi-Attribute Method (MAM) and High-Throughput Screening (HTS) to find the most stable clones that generate proteins with the proper folding and structure.
This stage is the centre stage of production. Once cells are chosen, they are scaled up in bioreactors by the process called fermentation. Every cell has specific nutritional requirements to grow and produce the target protein. In bioreactors, cells nutritional requirement is fulfilled by Biological Media Bases which are food for microbes.
Glycosylation and other Post-Translational Modifications (PTMs) are directly impacted by the media’s composition. A small change in the nutrient profile can alter the protein’s sugar patterns which can leads to a failed batch, economic, resources, and energy lose.
After fermentation is complete the advanced chromatography techniques such as Protein A and Ion Exchange is used to harvest and purify the protein. In modern facilities to minimizes the risks of contamination and to speed up the batch transitions, they are using Single-Use Technologies (SUT).
As the cells are produced by consuming Media Bases, so to ensure the high similarity of biosimilar, its food source means Media Bases need to be “highly consistent.” TM Media’s range of Biological Media Bases is manufactured with the quality that can ensure maximum protein expression and high-density fermentation.
At TM Media, we are offering over 100 Media Bases to fulfil a variety of needs,
Peptones are produced by hydrolysis of proteins by enzymes or acids.
Tryptone is a high-tryptophan pancreatic digest of casein. It is necessary for the microbial expression systems that make insulin and other biosimilars.
Protease Peptone offers high-molecular-weight peptides that help picky organisms grow.
Yeast extract is the superfood in fermentation. It catalyses the metabolic process by providing trace elements, nucleotides, and B-complex vitamins to cells. It prevents the formation of inclusion bodies by ensuring cells have the energy to fold proteins correctly.
When Pichia pastoris, a yeast cell is used for biosimilars production, Malt extract plays an important role as a carbon source and osmotic stabilizer.
The requirement of Biopharma SHAKTI initiative is Quality by Design (QbD). To guarantee a smooth scale-up, our Biological Media Bases go through extensive testing:
Explore TM Media’s complete range of Biological Media Bases and Ingredients here.
Chemical generics are exact replicas created through chemical synthesis. Living cells are used to create biosimilars; due to the inherent variability of living systems, “high similarity” necessitates extremely precise fermentation and media quality.
No, the amino acid profiles of various peptones (meat, soy, and casein) differ. For instance, tryptone is better for high-yield microbial protein expression, but soyatone (plant-based) may be preferred for animal-origin-free (AOF) processes to lower viral contamination risks.
Through the Biopharma SHAKTI scheme, the CDSCO regulatory cadre is strengthened, more than 1,000 accredited clinical trial sites are created, and ₹10,000 crore is allocated for infrastructure. This shortens the time and expense it takes for Indian businesses to obtain international approval for biosimilars.
Yes. TM Media helps manufacturers meet contemporary safety and ethical standards by providing a wide range of 100% animal-origin free yeast-based ingredients and vegetable peptones.
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