Contract Manufacturing Services at GVK BIO

GVK BIO offers long term Contract Manufacturing services right from strategic
partnerships in development, validations, DMF filing and commercial
manufacturing of Active Pharmaceutical Ingredients (APIs)/advanced
intermediates to APIs. We have flexible business models to support various
client needs:

A. Process optimisation, technology transfer, validations and DMF filing

followed by manufacturing upon commercialization
B. Technology absorption, validations, DMF filing support and Commercial
manufacturing
C. Technology absorption and commercial manufacturing

We have a diverse scientific team with

expertise to meet API and advanced
intermediate needs centred on the rapid
synthesis of supplies. Our project
management and technical teams ensure
a seamless technology transfer of
processes, as projects advance from
feasibility to DMF filing through complete
process optimisation, process validations
and stability program. We can optimise
and develop robust and cost efficient
processes for large scale manufacturing
using environment friendly routes under
GMP conditions with globally acceptable regulatory guidelines.

The combination of development experience, manufacturing infrastructure

and regulatory expertise makes GVK BIO a preferred strategic partner for
reliable, cost effective, long term contract manufacturing partners for
APIs/advanced intermediates.
GVK BIOs manufacturing facility has approvals from worldwide regulatory
authorities like USFDA, EDQM, PMDA, KFDA and WHO GMP. These
accreditations facilitate faster and easier approvals of DMFs/dossiers for our
business partners.

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

Commercial synthesis route scouting

Commercial process development and optimisation through DoE and QbD

Stepwise unit operation studies and defining critical process parameters

Impurity profiling and define control measures

Documentation for all kinds of regulatory filings

Our commercial manufacturing facility is co-located with our pilot plant,

providing end-to-end API service from feasibility phase in 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.

Our facilities can scale up all types of reactions, including asymmetric

hydrogenations, air and water sensitive metal catalytic reactions, high
temperature, high pressure, cryogenic and oxidations reactions.

The manufacturing facility has wide range of equipment:

Reaction vessels starting from capacity 20 L to 6000 L

Material of construction: stainless steel, glass lined, glass, halar coated,
hastelloy-C, etc.
Utilities ranging from -70C to +200C
Supporting equipment to handle all kinds of unit operations
GVK BIOs manufacturing team has expertise to handle a wide range of
operating conditions with flexible scales. Over the years we have exhibited
exemplary process and technology capabilities for NCEs and commercial
production of advanced intermediates/APIs. Our process development,
technology transfer and commercial execution teams collaborate seamlessly
to provide best-in-class concept to commercialisation timelines.

Salient features:

Driven by the need to design an economic and robust process with

defined in-process controls to yield optimum 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
 Manufacturing Infrastructure:

GMP compliant six manufacturing blocks with varied capacities ranging

from 20 L 6,000 L
Total reaction volume capacity: 170,000 L
MOC: All glass, glass lined, SS & Hastelloy reactors
Hydrogenation capabilities: 50 L to 2,000 L, upto 25 bar and large scale
column chromatography
Class 100,000 cleanroom, kilo labs and powder processing area
Stability chambers for conducting stability studies at all conditions

About GVK BIO:

Established in 2001, GVK BIO is one of Asias leading life sciences service
organizations. At GVK BIO, we blend science with people and technology to
help accelerate drug discovery and development for more than 400 clients
globally across small and large molecule platforms. Our clients include the
worlds top 10 corporations in the field of Pharmaceutical, Biotechnology and
Agrochemicals along with leading Academic institutions.

For further information, please contact: