At Matrix Laboratories, we aim to be a chemistry solution provider for drug development needs. We give each project individual attention because every project presents unique challenges and opportunities. We maintain a high level of confidentiality, solve difficult problems and handle most aspects of chemical development and manufacturing.
We offer contract research & development services during the early stages of development and contract manufacturing for projects that have advanced further in development cycle and are being considered for commercial manufacturing.
Our customers are reputable global pharmaceutical companies engaged in full-scale drug discovery, development and commercialization of New Chemical Entities (NCEs).
Contract Research & Development
We offer contract research and development services for chemical development of NCEs, from lead optimization through pre-clinical development and into manufacturing of active pharmaceutical ingredients for clinical development phases.
To partner in your success, we provide total solutions or 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 screening for salt and polymorphic form investigations for your unique molecule,
Develop and validate analytical methods to support the range of activities from the laboratory to the plant and to support regulatory filings,
Conduct release testing as per customer's specification and standard operating procedures and
conduct stability studies to support manufacturing processes and regulatory filings.
Contract Manufacturing Our ability as a commercial-scale manufacturer of many active pharmaceutical ingredients (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 customers’ intellectual property.
We will…
Conduct scale-up studies for any given process,
Conduct boundary evaluations,
Undertake a reduction in cost of raw materials on existing processes,
Conduct alternate green chemistry initiatives,
Undertake process qualification and validation batches and
Undertake commercial manufacture of your API or intermediate.
We provide…..
State of the art facilities approved by the U.S. Food and Drug Administration, the Health Care products Regulatory Agency and Australia’s Therapeutic Goods Association;
A total reactor capacity of 750,000 liters (both glass-lined and stainless steel);
High quality documentation with data traceability to primary records and
Regulatory documentation for U.S. and European markets (e.g., drug master files).
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 current and future needs,
Keep your customers need in mind and appreciate the cross-functional nature of drug development,
focus on good science,
adhere to timelines and
devote ourselves to quality.
Team Approach
Your project is assigned to a highly 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 among all concerned players. Everyone at Matrix engaged in contract research and development is fluent in spoken and written English.
Although we are halfway around the world, we are just a phone call away. All senior 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 your 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 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 quality assurance/quality control.
Intellectual Property (IP)
We make a strong and lasting commitment to protect every customer's IP, and we have a track record to prove it.
Innovations developed by Matrix in areas related to a customer's process, the synthesis route, salt and polymorphic form development will pass directly to that customer.
Synthetic Chemistry
We offer synthetic chemistry services for….
Making supplies (from grams-scale to kilograms-scale) under cGMP protocols in the laboratory and in our kilo-lab facility,
Our research and development expertise lies in the areas of…
Chiral separations,
Stereoselective synthesis,
Cryogenic reactions
High vacuum distillation,
Use of resins/molecular sieves
Polymorphism studies.
Biotransformation/enzymatic reactions and
Peptide Synthesis, purification and characterization
Examples of reactions we can handle appear below.
Alkylations
Metal Hydride Reactions
Friedel-Crafts Acylation
Nitration
Chlorosulphonation
Halogenation
n - BuLi/LDA/LiHMDS/Titanium trichloride mediated reactions
Azidation reactions
Hoffmann Reaction
Oxidations/ Chiral oxidations
Grignard Reactions
Cyanations
Reductions/Chiral reductions (using Sodium borohydride, Lithium aluminium hydride, diborane, Sodium dithionate, Vitride and other complex reagents)
Catalytic Hydrogenations (Using Palladium or Ptatinum on Carbon, Raney nickel etc)
Glycosidations
Resolution (Chemical and Enzymatic)
Couplings ( Normal as well as Palladium mediated couplings Such as Heck, Suzuki, Negishi etc)
Peptide coupling and Peptide separations.
Process Development and Scale-up
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 the process is safe when scaling up.
We can undertake technology transfer to a customer's site, including the production of qualification and validation batches for regulatory filing purposes. However, we prefer for customers to use our modern facilities that are approved by the U.S. Food and Drug Administration, the Health Care products Regulatory Agency and Australia’s Therapeutic Goods Association.
Some of our routine capabilities in our facilities are listed below:
Hydrogenation / high pressure reactions up to 20kg/sq.cm (250 ltrs to 2,000 ltrs),
High-vacuum distillation units,
Reaction in the temperature range of -60 Cº to 270 Cº,
Separate cGMP pilot facility for bio batches,
Dedicated Sodium hydride handling facility and
100 kg/hr air jet micronisation facility.
We have two 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 stainless steel
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 - 150-2,000 L cap-stainless steel, glass-lined reactors
Driers (vacuum, tray and rotary cone vacuum)
Separate powder processing area with dedicated air-handling systems
Analytical Sciences
We have a state-of-the-art analytical facility, Where HPLCs, GCs , UPLC’s, HPTLC’s and LC-MS with various modes of detection are routinely used.
We also have the latest NMR (300 MHz), XRPD’s, FTIR, DSC, TGA and particle-size determination instruments for more sophisticated investigations.
We develop and validate methods for…
Active pharmaceutical ingredients and their intermediates for chromatographic purity and assay
Chiral analysis,
In-process control,
Cleaning verification/validation,
Raw material testing,
Residual solvents and
Ion chromatography and analysis.
We conduct more comprehensive investigations for…
Proof of structure,
Impurities,
Polymorphs and
Hydrates and solvates.
Stability Studies
We conduct stability testing of active pharmaceutical ingredients and intermediates that we manufacture for customers (in accordance with the customer's standard operating procedures).
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 and
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 standard operating procedures.
Regulatory Documentation and Filings
We are able to provide our customers with Chemical Manufacturing Control documentation for customer products that we have developed to support investigational new drug and new drug application filings. We also can file drug master files to facilitate the supply of key intermediates.
To aid our customers ' 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;
