Integrated Drug Discovery Services


LAXAI is the place for seamless integration from target validation to Pre-clinical candidate selection under one roof across the multiple therapeutic areas. We offer our clients a wide range of customised integrated drug discovery and development solutions, with core expertise in medicinal chemistry further augmented by preclinical services like Biology, DMPK and toxicology. We have delivered many clinical candidates and several leads for our Collaborators. We offer the following services.

  • Identification of Hit molecules (HI)
  • Identification of Lead molecule (LI)
  • Lead optimization (LO) to Development Candidate (DC) or Pre-Clinical Candidate (PCC)

Medicinal & Synthetic chemistry


Medicinal Chemistry (Integrated):

Our team consists of experienced professional chemists (Ph.D. and Masters) trained at leading big pharma companies and Universities in India, US an EU. Project-specific teams are organized upon client’s request and are always led by dedicated principal scientist and guided by experienced scientific management of LAXAI. Our highly skilled Medicinal Chemistry team with expertise and in-depth knowledge in preclinical drug discovery is well equipped to deliver on client’s expectations. The team has hands-on experience of working on projects in various therapeutic areas like Oncology, Central Nervous System, Inflammation, Metabolic Disorder and Anti-Infective.

Medicinal chemistry (Support):

Our team has the capability to do library synthesis, parallel synthesis, reference compounds, pro-drug synthesis, salt selection studies and Pre-clinical scale-up under GMP and non-GMP protocols.

Synthetic chemistry

Synthetic chemistry services provided by LAXAI are as below:

  • Multi-step synthesis and characterisation of target molecules.
  • Synthesis of Reference compounds and Metabolites
  • Custom synthesis of macrocyclics, reference standards & Impurity synthesis.
  • Library design for Macrocyclic, Kinases, Proteases, Linkers of bioconjugation (anti-body, peptide drug-conjugates), heterocyclic based boronic acid, boronic esters, Carbohydrates, Peptides (10-12 amino acid side chains).
  • Key intermediates synthesis of quantity from milligram to multi-kilogram scale.

We also synthesize compounds in a smallest quantity of a milligram to multi-kilogram in a cost efficient and in delivered in the given time. We deliver these compounds with COA’s, including analytical test reports and a concise final report in a format as desired by our client.


Research Informatics & In silico Drug Discovery


Our Computational Chemistry team excels in drug discovery design efforts in collaboration with medicinal chemistry, structural biology, biology and DMPK teams, by conducting molecular modelling studies – pharmacophore and QSAR modelling, protein structure-based drug design, ligand-based drug design, fragment-based drug design, homology modelling, docking & scoring, chemo-informatics analysis and de novo designs. The team extensively utilizes in-house expertise in software development, chemo-curation for driving molecular designs


In-vitro Biology


As part of integrated drug discovery services LAXAI provides high throughput platforms for rapid screening of compounds. We provide tailor made biochemical and cell based assay development services to meet the needs of clients to aid screening campaigns.


DMPK


In vitro facilities at LAXAI provide ADME (absorption, distribution, metabolism, excretion) services with a quick turnaround time to enable faster and improved decision making points for our clients. We also offer this as standalone service.


ND/NDA/ANDA Enabling safety evaluations**

  • Mammalian Toxicology
  • Genetic Toxicology
  • Safety Pharmacology
  • Immunotoxicity
  • Neurotoxicity
  • Bio-analytical

In-vivo Biology


DMPK*

  • PK in mouse and rat (Normal & Tumor bearing) for IND and NDA submissions
  • Dog PK
  • Rapid pilot PK for the early pre-clinical support
  • Tissue distribution studies
  • Excretion studies
  • Bioavailability studies
  • Statistical analysis of PK data using WinNonLin

Pharmacology*

  • Oncology Models
  • CNS Models
  • Inflammation Models
  • Metabolic Disease Models

*Studies will be carried at 3rd party preferred collaborator
**Studies will be performed under GLP and AAALAC accredited third party collaborator


Analytical R & D


LAXAI offers a range of analytical solutions supported by state of the art facilities, advanced analytical instruments and efficient analytical team. The analytical team works closely with our chemists and takes charge for method development, preparative purification and characterization, allowing the chemists to target the trouble-shooting time and efficiency, on delivery of chemistry.

  • Method development & validation
  • Structural Elucidation
  • Stability studies
  • Physicochemical property determination (logP, logD, Solubility, pKa)
  • Impurity profiling

Instrumentation

  • NMR: Bruker 400 MHz and can perform 1H, 13C, 11B, 19F, 31P and 2D NMR experiments like COSY, ROSY, Hetero COSY, HMQC, HMBC and Variable temperature experiments
  • HPLC: UV, PDA & ELSD detectors (Waters) including CIS and Chiral columns
  • Preparative HPLC up to 2 g per injection
  • LC-MS: Single quad (Agilent), Ion Trap (Thermo)
  • GC-MS: Agilent with auto sampler
  • Polarimeter: Jasco P-130
  • UV-VIS Spectrophotometer: UV-2450, Shimadzu
  • FTIR: Prestige 21, Shimadzu

API R&D


LAXAI is one stop solution partner for complete value chain of services from early discovery to commercial manufacturing. We offer services right from early lead discovery till commercial manufacturing of NCE’s and generics.

LAXAI offers entire services for API and intermediates development including Lab assessment, Process optimization, Scale-up, API synthesis, API commercial Manufacturing. LAXAI’s state-of-the-art facilities including Analytical facility helps us to handle complex API’s and Intermediates and highly potent materials at both developmental and commercial scale to cater excellent quality services to our clients. Laxai’s competent and experienced API team with global experience capable to deliver the projects at agreed timelines to meet client expectations with unparalleled quality and cost. Our proactive project management system offers seamless communication for project updates to clients.

LAXAI has globally compliant cGMP facilities. With proven chemistry expertise and experience, LAXAI offers contract research and development, manufacturing services of APIs and intermediates.


Formulations R&D


Through a partner, LAXAI offers a range of formulations R&D services. The team is equipped with state of the art laboratories and latest of the instruments to ensure deliveries of highest standards.

The formulation team has the capabilities and expertise to develop Oral solids, liquids, and Topical ( Cream, ointment, patches) dosage forms. Below are the list of services offered:

  • Development & Technology transfer to partner site
  • Pilot & Pivotal Bio support
  • Exhibit/ submission batches manufacturing
  • CMO Identification & partnering

Contract Development and Manufacturing Organization (CDMO)


We provide end-to-end services to bring a drug to the marketplace quickly and safely. We offer Pharmaceutical Development and Manufacturing solutions through the drug life cycle.

At LAXAI, we have created the infrastructure to provide services for an effective management of drug’s life cycle. We provide services from Discovery to Development and Commercial Manufacturing of NCEs. Our capability as an integrated service provider and experience with various technologies enables us to serve Innovator companies worldwide.

At LAXAI, our focus is on serving as a 'Customer Centric' organization. We accomplish this by keeping the "Pulse of the Customer" at the heart of our mission. We have a robust feedback mechanism which enables us to continuously improve our internal processes, communications and program management.

From Concept to commercialization

We help to increase the efficiency of production processes and reduce the risks associated with product development and/or commercialization. In this endeavor, our approach is to improve and back integrate the stages which are limited for scalability in the initial discovery thereby making the entire drug life cycle process more cost efficient with higher yields.

Meeting Your Small Molecule Needs

LAXAI recognizes that synthetic chemicals still represent 80 to 85% of the drugs on the market as well as those in late-phase of development. We strive to adopt a broad, balanced and innovative portfolio of chemical technologies to suit the needs of our clients. Using various latest chemical processes - including continuous flow technologies and biocatalysis- we offer our customers exclusive synthesis of synthetically challenging high value KSMs, RSMs and NCEs under cGMP for use in pharmaceutical products.

Backward-Integrated Industrial Manufacturing

We can manufacture quantity from kilo to tonne scale. Our manufacturing strength stems from our comprehensive integrated network of resources for backward integration of starting materials/reagents, non-GMP intermediates at scale and securing the supply chain in terms of quality and costs. Our global footprint provides a highly valued risk mitigation and IP clean (in case of new synthetic route) asset.

cGMP and ISO-Certified Manufacturing Solutions

By optimizing synergies between new technologies and classical chemistry, LAXAI provides alternative and innovative manufacturing pathways. Since 2007, LAXAI has been investing in advanced chemical technologies and state-of-the-art facilities for production capacity that now ranges from gram to multi-kilogram quantities. Our modern chemical technology toolbox is based on a broad range of expertise at our manufacturing sites.
LAXAI’s world-class manufacturing facility provides customers with complete manufacturing packages, created through close relationships, under strict confidentiality. The manufacturing facility complies with all regulatory guidelines and requirements cGMP and are successfully inspected/approved by US FDA, EDQM as well as MHRA and supplies NCEs, intermediates and RSMs to global innovators. The facility is equipped with flexible and versatile infrastructure, tailored to fit complex chemistries and smaller volumes.

Our Differentiation

  • Improved product quality - every development project request is carefully analysed and various alternative options are explored for arriving at the best solution.
  • Create a robust, comprehensive control strategy using the principles of the Design of Experiments (DoE) and Quality by Design (QbD). This enables the chemistry developed to be readily scaled as the molecule advances from early clinical phase to commercial production.
  • Speed to market by focusing resources on core competencies and optimizing, ROI.
  • Access to our advanced technologies and optimized processes to achieve CMC development milestones.
  • Benefit from LAXAI’s experience with world-wide regulatory authorities.
  • We have a team of professionals with international experience dedicated to deliver successful outcome for our collaborators.

Manufacturing


With two manufacturing facilities in Pashamylaram and Jeedimetla. LAXAI offers entire services for API and intermediates development including Lab assessment, Process optimization, Scale-up, API synthesis, API commercial Manufacturing. LAXAI’s state-of-the-art facilities including Analytical facility helps us to handle complex API’s and Intermediates and highly potent materials at both developmental and commercial scale to cater excellent quality services to our clients. Its competent and experienced API team with global experience capable to deliver the projects at agreed timelines to meet client expectations with unparalleled quality and cost. Our proactive project management system offers seamless communication for project updates to clients. LAXAI has globally compliant cGMP, USFDA, MHRA, K-FDA and COFEPRIS approved facilities.


Large Molecule Therapies


We have successfully created a portfolio of biosimilars based on their proprietary platform technology. LAXAI’s technology is based on novel vector designing and cell line development which can lead to significantly higher yields of product. Currently, Trastuzumab, Bevacizumab, Adalimumab and Filgrastim are in advanced stage of development. Furthermore, LAXAI plans to increase its spectrum of biosimilars in the area of oncology and auto-immune disorder.