At Matrix Laboratories, we aim to be a chemistry solutions provider for your small molecule Drug Development needs. We give each project individual attention because every project presents its own challenges and opportunities. We maintain a high level of confidentiality, solve difficult problems and are equipped to handle most aspects of Chemical Development and Manufacturing.
We offer Contract Research & Development services during early stages of Development and Contract Manufacturing for projects that have advanced further into development and are being considered for commercial manufacturing.
Our customers are reputed global pharmaceutical companies engaged in full-scale Drug Discovery, Development and Commercialization of New Molecular Entities (NMEs).
Contract Research & Development
We offer contract R&D services for Chemical Development of new molecular entities (NMEs) from Lead Optimization through Pre-Clinical Development and into manufacturing of API for Clinical Development phases.
In order to partner in your success, we could provide you with total solutions or with selected services.
We…
Make lead supplies in multi-gram quantities in the laboratory
Develop robust processes for making pre-clinical and clinical supplies in the kilo-lab or pilot plant
Conduct salt and form investigations for your unique molecule
Develop and validate Analytical Methods to support the range of activities from the lab to the plant and, to support regulatory filings
Conduct release testing as per customer's specification and SOPs
Conduct stability studies to support manufacturing processes and regulatory filings
Contract Manufacturing Our ability as a commercial-scale manufacturer of many APIs with competitive pricing is well-documented. We bring to your project, diverse chemistry expertise coupled with problem-solving skills. We undertake exclusive manufacturing services for your APIs and intermediates without compromising our customer's intellectual property.
We will…
Conduct Scale-up studies for any given process
Conduct boundary evaluations
Undertake a reduction in cost of goods on existing processes
Conduct alternate Green chemistry initiatives
Manufacture Qualification and Validation batches
Undertake Commercial Manufacture of your API or intermediate
We provide…..
The state of the art facilities approved by the US-FDA, MCA and TGA
A total reactor capacity of 750,000 liters (both glass-lined and SS)
High quality documentation with data traceability to primary records
Regulatory Documentation for US and European markets (e.g. DMFs)
Customer Satisfaction
Our primary goal is to satisfy you, our customer. We understand that every customer has different needs and that project priorities shift as new knowledge and information is generated. Our job is to respond to these changing needs quickly and efficiently.
We….
Listen to you and understand your immediate and future needs.
Keep your customers in mind through an appreciation of the cross-functional nature of Drug Development
Focus on good Science
Adhere to Timelines
Devote ourselves to Quality
and Share the risks with you
Team Approach
Your project is assigned to a tightly focused cross-functional project team headed by a team leader.
A team leader provides the focal point for directing all your project requirements.
Project teams have a flat organizational structure to ensure that your changing project needs are quickly and efficiently communicated to the team and translated into necessary action.
Communication
Successful collaboration is possible only through effective communication between all concerned players. Everyone in Matrix engaged in contract research and development is fluent in spoken and written English.
Although we are half way around the world, we are just a phone call away. All team members are equipped with phone and broadband Internet connections. For all project related matters, we operate via secure e-mail.
We manage time zone differences to our advantage. Team members are available from 6.00-20.00 IST (0.30-14.30 GMT), which is 20:30-10:30 EST (17:30-7:30 PST). Teams can interact via our video-conferencing facility on a periodic basis.
On mature projects, we have created the possibility of having multiple points of interaction with various experts within Matrix whether it relates to synthetic chemistry, analytical development, regulatory or QA/QC.
Intellectual Property (IP)
We make a strong and lasting commitment to protect the customer's IP and we have a track record to prove it.
Innovations developed by Matrix in areas related to the customer's process, the synthesis route, salt and form development will pass on directly to the customer.
Synthetic Chemistry
We offer synthetic chemistry services for….
Making supplies (from grams-scale to kgs-scale) under cGMP protocols in the laboratory and our kilo-lab facility
Our chemists have experience in scaling up processes from lab-scale to kilo-lab to pilot-scale to commercial.
We perform Safety testing and Hazard evaluation to ensure that process is safe when scaling up
We can undertake technology transfer to the customer's site including the production of Qualification and Validation batches for filing purposes. However we would like for the customer to use our modern facilities that have US-FDA, MCA and TGA approvals.
Some of our routine capabilities in our facilities are listed below:
Hydrogenation / high pressure reactions upto 20kg/sq.cm (250 ltrs to 2000 ltrs)
5 high vacuum distillation units
Reaction temperatures from -60 ºC to 270 ºC
Separate cGMP pilot plant for bio batches
Dedicated NaH handling facility
100 kg/hr air jet micronisation facility
We have 2 pilot plants with complementary capability to react speedily to a customer's supply needs.
Pilot Plant I
Reactors (8) from 20-250 liters, both glass and SS
Special equipment - All glass reactors, 20-150 liters.
Vacuum driers and rotary cone vacuum driers
Separate powder processing area with dedicated air-handling systems
Pilot Plant II
Reactors (24) of various sizes - 150- 2000 L cap- SS, GLRs
Driers ( vacuum, tray, rotary cone vacuum driers)
Separate powder processing area with dedicated air-handling systems
Analytical Sciences
We have a state-of-the-art Analytical Sciences facility. HPLCs, and GCs with various modes of detection are more routinely used along with HPTLC.
We also have the latest HPCE, NMR (300 MHz), XRPD, FTIR, DSC, TGA and Particle Size instruments for more sophisticated investigations.
We develop and validate methods for…
API (& Intermediates) Assay and Impurity profile
Chiral Analysis
In-process control
Cleaning verification
Raw material testing
Residual solvents
Ion Analysis
We conduct more comprehensive investigations for…
Proof of Structure
Impurities
Polymorphs
Hydrates and Solvates
Troubleshooting processes
Stability Studies
We undertake stability testing of API and Intermediates that we manufacture for the customer (in accordance with the customer's SOPs).
With our customer's approval, we will…
Design the stability protocol and testing schedules
Store the samples (using ICH conditions)
Develop and validate stability-indicating methods
Conduct periodic testing according to the test schedule
Conduct detailed investigations for inexplicable results
We are equipped with stability chambers for conducting long-term and accelerated stability studies. These are periodically calibrated and maintained according to our SOPs.
Regulatory Documentation and Filings
We are able to provide our customers with CMC documentation for customer products that we have developed, to support IND and NDA filings. We can also file DMFs to facilitate the supply of key intermediates.
In order to aid our customer's regulatory filing efforts we can provide the following documentation
Test Method Reports
Analytical Method Validation reports
Stability Reports
Audit Reports for Labs, Manufacturing facilities and Raw Material suppliers
