We offer guidance for product selection, a critical step in business development, based on market research, regulatory ease, and economic feasibility. This is followed by clone development, including plasmid/vector selection, gene synthesis, genetic constructs, and high-yielding clone selection for biosimilars.

Our team having more than 25 years of experience in the area of fermentation and purification and having worked in companies like, Wockhardt, Biocon, Intas, Akzo Nobel, Schering Plough Merck, SPIMACO, NAIST- Japan can handle bacterial projects from 5 to 10,000 and mammalian projects from 5 to 500-liter scale respectively. The products handled at various scale by the team include Insulin Human, Glargine, Lispro, Human Growth Hormone, Bevacizumab, Adalimumab, Rituximab and Recombinant Human Erythropoietin.

We can handle and optimise formulations and fill finish for the following depending on the type of biosimilar to be manufactured in: Vials. Pen and Cartridge. Prefilled Syringes. The excipient and buffer for a respective formulation are selected so that the protein structure remains stable and comparable to innovators product. We conduct exhaustive stress studies, container closure studies etc indicating a stable formulation based on which the shelf is assigned.

We develop and standardise the analytics required for the quality control testing of Biosimilars including the batch release tests. The battery of tests included include, Protein assays, SDS PAGE, Western Blotting, HPLC, ELISA, Impurity profile, Bioassays, PCR, Infectivity assays etc. including the Microbiological tests. Method Verification / Validation activities for a respective test shall be taken up as required from initiation till the end as per regulatory norms.

Our team is experienced in preparation of product dossiers both for domestic and international regulatory approvals. Product dossier is prepared based on studies of product development at each unit operation and this information will be provided based on regulatory guidelines. The dossier includes description of manufacturing, control and characterisation of Drug Substance and Drug Product.

Our tech transfer package includes end-to-end service, right from ready recombinant cell line, through process development and formulation till the final finished product. The information will be provided on functional disciplines required to develop and commercialize a drug substance or a drug product. Our expertise in R&D, manufacturing, quality, regulatory and cGMP under one roof ensures a fast, meticulous, and systematic tech-transfer, with a commitment for continual improvement where required.

We provide support for regulatory approvals of biosimilars right from the R&D stage, through scale up and clinical studies till the final market launch for a respective product. We offer regulatory service support to minimise product development time and accelerate product approval for manufacturing and marketing.

Planning and design of a facility is very critical for manufacturing of a biosimilar. The facility must comply to the applicable cGMP requirements with sufficient capacity as per the market demand. Needless to say, flexibility in the scale of manufacturing also must be in built in the facility design. Our team can conceptualise the facility design based on the process requirement, process flow and cGMP requirements.

QMS as per ICH 10 starting with a Quality policy, Quality manual and the related Standard Operating Procedures covering the full set of Quality Assurance elements including risk assessment and mitigation, change management, deviation management, Investigations and CAPA etc. QMS also covers the much important training and development activities for the required skillset including people development. Continual improvement is deployed using the Kaizen principle, Lean manufacturing, Right First-Time concept, and other principles of Lean Six Sigma manufacturing.