The global scenario today demands the best collaborative practices between different parts of an organisation thereby maximising the output. One of the key performance indicators in Pharma R&D is the number of new drug candidates in pipeline. Nominating candidates with best possible properties gives a higher likelihood for it to survive and convert to the required NCE.

A pronounced need to make critical judgements and forecasts on cost of goods for NCEs/APIs, scalability, route scouting and design, intellectual property, etc. is more norm than a requirement. At GVK BIO, we strongly believe in the importance of effective QbD during development of late stage NCEs. We involve cross-functional team of process chemists, analysts, process engineers, quality assurance, sourcing and manufacturing, which helps us to consider the right input variables during designing and developing the process. Cumulative wisdom of the team during FEMA ensures robust processes resulting in improved efficiency, reduced risk and fewer failures. This teamwork also enables us to achieve one of the elements of ICH Q 10, continuouss improvement, within the boundaries of design space with minimum regulatory concerns for the customer.

GVK BIO offers an extensive Process R&D support, designed to address the issues involving both scientific and communication challenges. We are cognizant of the need for customisation as per client’s need so as to perform and progress in a collaborative partnership.

Our scientists are experienced in developing short and efficient process for complex pharmaceutical products by utilising in-house expertise and state-of-the-art technology.

Chemistry Capabilities:

  • Alkylation and Acylation
  • Aminations (Reductive/Chiral)
  • Asymmetric Hydrogenations (Catalytic and hydrogen transfer)
  • Chiral synthesis
  • Grignard reactions
  • Organometallic (Alkyl Lithium/LDA)
  • Reductions using metal hydrides
  • Resolutions (Kinetic and Diastereoselective)
  • Boronic acids
  • Bio and Chemo (using commercially available enzymes/catalysts)
  • Nitration
  • Cyanation
  • Diazotization
  • Azidation
  • Sulfonation
  • Halogenations

Other support services include:

  • Process validations, analytical method development and validation
  • cGMP manufacturing
  • CMC and other Regulatory filings
  • Impurity identification, characterisation and synthesis
  • Stability studies

The global scenario today demands best collaborative practices between different parts of an organisation thereby maximising the output. One of key performance indicators in Pharma R&D is the number of new drug candidates in pipeline. Nominating candidates with best possible properties gives a higher likelihood of it to survive and convert to the required NCE.

A pronounced need to make critical judgements and forecasts on cost of goods for APIs, scalability, route scouting and design, intellectual property, etc. is more norm than a requirement.

GVK BIO offers an extensive Process R&D support, designed to address the issues involving both scientific and communication challenges. We are cognisant of the need for customisation to a client’s needs as the key driver to perform and progress in a collaborative partnership.

We can develop non-infringing processes or an improvement of existing processes to scale-ups by utilisation of in-house expertise and state-of art technology, including:

  • Statistical design of experiments (DoE)
  • Reaction calorimetry to assess and develop safe processes
  • Real time in-process control and reaction monitoring

Other support services include:

  • Process validations, analytical method development
    and validation
  • Regulatory filings
  • cGMP manufacturing

Manufacturing Services

Manufacturing expertise is built with a keen eye on capability to handle a wide range of operating conditions with flexible scales. GVK BIO has exhibited exemplary process technology for both NCEs, progressive drugs and in production of advanced intermediates/APIs.

Process Development, Technology Transfer and Commercial Execution teams involve seamlessly providing best in class concept to commercialisation timelines:

  • Driven by need to design most economic and robust process with defined in-process controls to yield optimum yield and desired quality.
  • Provide engineering support from initial stages of product development by identifying process specific facility requirements to deliver a validated process at designated scale.
  • Observe and assimilate process operations and all critical parameters and systematically execute under guidelines charted by Quality Management Systems.

Contract Research & Manufacturing Services (CRAMS)

pertains to outsourcing services/products from low-cost providers. Pharmaceutical Multinationals have traditionally been outsourcing intermediates, API’s (Active Pharmaceutical Ingredients) and Formulations (Finished Dosage forms). Since the late 1990’s, CRAMS has gained more importance, as the MNC’s have come under pressure to maintain their profitability. CRAMS basically consists of the following two activities — Contract Research & Contract Manufacturing.

Contract Research

Contract research includes custom chemical synthesis and clinical trials. Over the last few years, the need to outsource for Big Pharma has increased considerably, and outsourcing is gradually moving from being just a tactical or opportunistic option to a more strategic one. Some factors MNC’s would consider while “shopping” for a Clinical Research Outsourcing partner:

1. Cost efficiency
2. Timely delivery
3. R&D skills
4. Regulatory Expertise
5. IPR Compliance

Contract Manufacturing

Contract manufacturing could involve supply of intermediates, APIs or formulations (for on-patent or off-patent molecules). “Big Pharma” Outsource due to:

1. Off-patent products face competition from generic versions, most of which originate from low cost destinations such as India, making it important for Big Pharma to look for alternative low cost sources of manufacturing.
2. Difficulties involved in handling industrial operations as well as keeping pace with changing FDA norms increase the attractiveness of outsourcing as a strategic option.
3. Economically viable: A sponsor can convert the fixed costs of maintaining the personnel, expertise and facilities (for e.g. data management) necessary for clinical trial management into variable costs.
4. Regulatory expertise: India has around 75 plants approved by the US-FDA.

Inogent can partner for Manufacturing New Chemical Entities (NCE’s), Key Starting Materials (KSM’s) and Active Pharmaceutical ingredients (API)/Intermediates.

Early Phase Development & Clinical Manufacturing

Time is of the essence in early phase development and we at Inogent are committed to helping all our customers achieve a fast, efficient turnaround time. Our unique “Fit-for-Purpose” process development philosophy would enable you to obtain API and initiate clinical studies as early as possible.

We are innovative and highly flexible. Our technical teams with wide range of experience are focused & driven to meet your API and advanced intermediate needs, centred on the rapid synthesis of supplies for your early clinical trials.

Working alongside our highly experienced project management and dedicated customer service team, the technical teams have the expertise to ensure a seamless technology transfer of processes, as programs advance from preclinical to commercial, using our process R&D and API manufacturing capabilities.

The combination of development expertise, manufacturing equipment and state-of-the-art facilities makes Inogent one of the preferred & strategic partners for reliable, cost effective long term supplies of your intermediates and API.

We can optimise and develop robust and cost efficient processes for large scale manufacture using environment friendly routes, as much as possible.

Our dedicated late stage development teams have extensive experience in the following:

  • Commercial synthesis route scouting
  • Commercial process development and optimization through DoE and QbD
  • Stepwise unit operation studies and defining critical process parameters
  • Impurity profiling, fate and control
  • Regulatory starting material definition

Our commercial manufacturing facility is co-located with our pilot plant, providing “end-to-end” API service from early phase R&D to commercial launch. This integration eliminates the need for tech transfers when a project advances through each development phase, allowing us to help reduce delivery time while providing cost-effective services.

We have effective project management and customer service.

Our facilities can scale up all types of reactions, including asymmetric hydrogenations, air and water sensitive metal catalytic reactions, high temperature, high pressure, low temperature and oxidations reactions.

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