About – Gnanika

Overall solutions to

The Biopharma, Biotech, Healthcare and Medical device companies for developing and manufacturing quality therapeutic products

Gnanika TechBio has highly qualified and experienced industry professionals working on projects throughout India and internationally. We have offices in Chennai, Bangalore, and Hyderabad, and a partner group in South Korea.

Gnanika TechBio provides best-in-class scientific advice and consulting services to the healthcare industry in quality, clinical/nonclinical, regulatory affairs, and project management for all Biologics and Biosimilar development (R&D) and manufacturing stages.

Gnanika TechBio provide service that includes microbiology techniques of product analysis, molecular Biology techniques of cloning and protein expression, upstream processing of cell biomass production, downstream processing of protein purification, and documentation. We act as the mediator between the regulatory agencies and healthcare product manufacturers.

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Problem?

The Healthcare industry includes products borne out of drug discovery programs, extensions to existing product lines, longstanding brand lines and generics, and prescription-only medicines.

A major challenge for the Healthcare industry is the long and risky development process for new drugs; this is costly and can take over ten years from the laboratory to clinical trials. Typically, only around few out of 100 compounds that have been assessed at the pre-clinical stage will reach human clinical trials. Of these few, only one will eventually be approved by the regulatory authorities. The investment of time and cost in such processes places a significant strain on drug developers. Gnanika TechBio provides early strategic advice in clinical, nonclinical, CMC/ manufacturing, and regulatory pathways to ensure clear routes and risk mitigation.

In addition to the regulatory and technical challenges, the founders had a personal interest, and recognition, that whilst drug development was an international industry, many in developing nations were receiving Healthcare products of lower quality, efficacy, and safety than those in the developed world.
This highlighted a fundamental need to support the international pharmaceutical industry to manufacture GMP compliant, well-regulated drugs.

Gnanika TechBio commits with biopharmaceutical and healthcare companies to develop drugs to cure incurable diseases.

Our core values to the clients: a superior level of service, value-adding support, our knowledge and extensive experience of the industry, as well as our professionalism and attention to detail in everything that we do.

The process of Biopharmaceutical development

Gnanika TechBio helps biopharmaceutical, healthcare, and medical device companies for developing, designing, and implementing the manufacturing processes for Biologics/Biosimilar production from microbial and mammalian cell lines.

Gnanika TechBio provides a superior level consulting service to the healthcare sector for quality product development with cost-effectiveness. We assist the biopharmaceutical organisation to develop stem cell therapy, gene therapy, and immunotherapy. We support the healthcare sector to develop and produce Biologics and Biosimilar including, monoclonal antibodies, vaccines, hormones, enzymes, peptides, etc.

Gnanika TechBio assures its customers to be competitive and help reach the Biologics and Biosimilar products faster.

Gnanika TechBio services (technical)

• Biologics product development (R&D)
• Biosimilar product development (R&D)
• Microbiology services – Finished products and Raw material analysis
• Molecular Biology services – Molecular Cloning and Protein expression
• Upstream processing services
• Downstream processing services
• Documentation services

Gnanika TechBio core services

• Regulatory affairs registrations support
• Regulatory affairs resourcing
• GMP / quality system development and support
• Pharmaceutical project and program management

Gnanika TechBio provides support to clients from product and clinical development, though product licensure, GMP compliance, maintaining regulatory strategies, and training.

Gnanika TechBio is currently working with biopharmaceutical companies to start-up biotech organizations. Early stage products have benefited from increased speed to market, through sound regulatory advice and guidance, whilst larger corporate clients have been able to outsource elements of their projects providing significant cost savings.

Each client has a dedicated project team to ensure work is managed and driven to deliver ahead of time, often below budget. Our consulting professionals integrate with the client company to ensure they deliver as part of the team, providing flexible support both onsite and remotely.

Gnanika TechBio commits with biopharmaceutical and healthcare companies to develop drugs to cure incurable diseases.
Our core values to the clients: a superior level of service, value-adding support, our knowledge and extensive experience of the industry, as well as our professionalism and attention to detail in everything that we do.

Sectors:-
With a team of expert consultants spanning a wide breadth of knowledge, Gnanika TechBio serves a diverse range of sectors.