“The team set-up more than 25+ large scale projects involving 300+ large scale Fume Hood facilities, Animal facilities (exceeding over half a million sq. ft.), Flexi labs and these can be easily customized by the end user. We possess the required expertise for High containment labs for potent drugs including Glove port hoods with Isolator, Testing lab for Inhalation drugs, Radioisotope labs etc.”
It can take up to fifteen years to develop one new medicine from the earliest stages of discovery to the time it is available for treating patients. The average cost to research and develop each successful drug is estimated to be $ 800 M to $ 1 Billion. For every 5000-10,000 compounds that enter the research and development (R&D) pipeline, ultimately only one receives approval. Success requires immense resources – the best scientific minds, highly sophisticated technology, world class infrastructure and complex project management.
Koncepo specializes in understanding the entire drug discovery, development, pre-clinical & clinical, manufacturing till it reaches to patients. We provide innovative, safe & functional solutions in every stage from programming to start-up stage to operations in both R&D and Manufacturing sectors.
- Pharmaceuticals
- Biotechnology
- Biomedical
- Nutraceuticals
- Food Processing
- Cosmeceuticals
- Environmental
- Beverage
As the entire drug discovery process goes through various development phases, demanding varied functional labs complying to personnel, product and environment safety standards. At Koncepo, we provide relevant, practical design and construction solutions to our clients, due to our understanding of ‘end-to-end drug discovery’ process from the earlier stages to the clinical trials to finally being available to patients. The designs of these labs are not only about satisfying regulatory guidelines where research is being carried out, but enabling processes that are operated in a controlled manner and finally manufacturing the product to meet its predetermined safety, efficacy and quality specifications. New research methods are constantly emerging. Multi and interdisciplinary research projects house a variety of research programs that have diverse needs.
Koncepo team possesses the expertise in developing facilities that can accommodate research groups of various sizes and different lab requirements :
- From drug discovery to development to pre-clinical trial processes that require – Wet / Dry / Clean / High pressure labs / High containment labs /Bio containment / Animal facilities / Flexi labs.
- Our well-planned approach during planning stage based upon the URS will resolve many issues such as collaboration without contamination, allowing for changing group sizes and appropriate lab utilities.
The globalization and open market policy – has generated globally acceptable manufacturing facilities that are compliant with various regulatory standards.
- Our pharmaceutical teams include knowledgeable peer review team and thought leaders who lend their talents to the advancement of the pharmaceutical engineering field, coupled with dedicated professionals who have gained experience from hundreds of pharmaceutical projects around the world.
- Our range of services that start from advanced planning and programming, to design, construction and commissioning, to startup, qualification, and validation – as these allow us to help clients facing challenges and also identify any opportunities for the client throughout a project’s lifecycle.
"The team set-up more than 25+ large scale projects involving 300+ large scale Fume Hood facilities, Animal facilities (exceeding over half a million sq. ft.), Flexi labs and these can be easily customized by the end user. We possess the required expertise for High containment labs for potent drugs including Glove port hoods with Isolator, Testing lab for Inhalation drugs, Radioisotope labs etc."
Pharmaceutical R&D and Manufacturing facilities are often heavily influenced by the user due to the specific process chemistry, more toxic compounds and specific physical forms. Increasing levels of GLP / GMP will also add to the requirement.
At Koncepo, we understand the prerequisites of site master plan that form the basis for early stage planning for Research facility campus or Manufacturing that addresses some of the early stage fundamentals for the success of the project.
“The laboratory module is the key unit in any research facility.”`
When designed correctly, a lab module will fully coordinate all the architectural and engineering systems. Typically, more than 50% of the construction cost of a laboratory building is attributed to engineering systems. Koncepo team ensures close coordination of structural and MEP systems for flexible, successful operating lab facility. Our expertise lies in :
- Choosing the right Safety enclosure for specific application and integrate with right HVAC system, Variable Air Volume system, Zoning and Pressurization of specialized labs, handling potent drugs.
- Performing exposure risk analysis for the containment measurement identifies Safe and Functional labs.
We work on manufacturing facilities that have multiproduct or general purpose, to cater for wide variety of compounds, processing characteristics and volumes required.
Our team in collaboration with the Biosafety team will provide a detailed risk assessment and advises the various design choices necessary. Designing a large-scale GMP production facility for biological production requires various types of risk assessments to be carried out. This is the main tool in obtaining a balance between the aspects where GMP and biosafety guidelines contradict each other. Only by evaluating the various risks involved in the project, can rational and optimal choices be made regarding facility design and construction.
Our objective is
- To create a safe environment in which research of infectious diseases can be carried out in a controlled manner
- To prevent escape of infectious agents,
- To minimize staff member’s and other people’s contact with infectious agents, both inside and out- side the containment zone, and to prevent the introduction of infectious agents into nature.
We have been able to successfully design and commission multiple BSL and Animal Facilities. Our in-depth understanding of the architecture, laboratory facilities, laboratory practices and techniques, safety equipment, and the building systems enable us to deliver tight environmental control over the facility. This practice helps to avoid introduction of microbes, which is an integral hygiene factor of such facilities.