Pharmaceutical and Biopharmaceutical Development

Pharmaceutical and Biopharmaceutical Development

You have identified a molecule to take forward, what next? MET can provide synthesis, analysis, process development, and small scale GMP production to deliver an efficient pathway to success.

MET can help you move your project forward by providing efficient, knowledgeable laboratory support from both our own and our partners' labs.

Our internal chemists are equipped with a wide variety of equipment to identify molecules and contaminants.

Method development/validation and transfer

  • Forced degradation as per ICH: Chemical (Acid, Base, Oxidation conditions) Thermal
  • & UV exposure
  • Raw material characterization as per latest pharmacopoeia (USP/BP/EP/IP/JP)
  • Impurity profiling: Method development, identification, isolation and/or synthesis & characterization
  • Qualification of standards: preparation, characterization & establishing assay by mass balance (potency determination)
  • Qualification of organic volatile impurities & residual solvents as per USP/EP/ICH
  • Batch release testing
  • Stability studies as per ICH guidelines
  • Dossier preparation & support in regulatory submissions

Our partner laboratories provide

Medicinal Chemistry

  • Synthesis of focused libraries, analog compounds, de novo libraries, fragment based libraries
  • Parallel synthesis (scaffold based) and support in lead optimization
  • Support in solving druggability issues
  • Custom synthesis (mg to kilogram scale)
  • New Chemical Entities (non-GMP, GMP)
  • Heterocyclic building blocks and scaffolds
  • Complex molecules including select natural products
  • Solution phase peptide synthesis and scale-up
  • Carbohydrate chemistry, organophosphorus compounds, specialized boronic acids / esters
  • Key / exotic raw materials, intermediates / advanced intermediates
  • Drug substances / pro-drugs
  • Impurities and stable metabolites
  • Support in identification and characterization
  • Preparation / isolation, qualification and supply
  • Working / reference standards - preparation, qualification and supply

Drug Development - CMC Services

  • Process development / optimization of NCEs
  • Forms selection (polymorphs and/or salts screening)
  • Material generation as required for preclinical studies
  • Material generation (GMP) as required for phase I & II clinical trials
  • Phys-Chem studies & qualification of standards
  • CMC dossier preparation

Analytical Services

Quantitative Bioanalysis
  • Maximum sensitivity for detection of trace level components
  • Enhanced selectivity for determination of components in complex biological samples
  • 21 CFR Part 11-compatible MassLynx Security Manager
  • QuanLynx™ Application Manager for automated batch quantitation with the advanced ApexTrack™ peak detection algorithm
  • System qualification (IQ/OQ/PQ)
  • Staggered chromatography to maximize sample throughput.

ADME Screening

  • Environmental control for large batches of samples
  • Multi-pump control for staggered chromatography or parallel analysis with MUX- technology
  • QuanOptimize™ and the QuanLynx Application Manager for automated methods development and quantification

Early Candidate Profiling

  • High throughput determination of physicochemical properties
  • Multi-pump control for parallel analysis using MUX-technology
  • ProfileLynx™ Application Manager for the automated calculation of solubility, permeability and stability of drug candidates

Food/Environmental Analysis

  • High sensitivity for trace contaminant monitoring
  • Enhanced selectivity for complex matrices
  • TargetLynx ™ Application Manager for automated quality control checks of quantitative results

Clinical Analysis

  • Optimum sensitivity for potent, low-dose therapeutic drug monitoring
  • QuanLynx Application Manager for automated batch quantification with the advanced ApexTrack peak detection algorithm

Bio-analytical Laboratory

  • Antibody Production, Purification, Labelling and Characterization
  • Biologics / Biosimilars / Biopharma CMC Support Assays
  • Final Product Characterization
  • Bioanalytical Services (PK / TK / Immunogenicity / In vitro Assays for Biologics / Biosimilars and Biopharma Products.)
  • Custom Assay Development Services
  • Stability Services
  • Clinical Trial Sample Analysis
  • Host Cell Protein Analysis
Related Topics

012-extractables-and-leachables-lumi-low-res HumanFactors adhesive-develpoemnts7 chemical-analysis

Extractables and Leachables                  Human Factors                Pharmaceutical Support                  Pilot Production

 

F2129 - Standard Test Method for Conducting Cyclic Potentiodynamic Polarization Measurements to Determine the Corrosion Susceptibility of Small Implant Devices has been revised to F2129-17a developed by Committee F04.15, ASTM BOS Volume 13.01.

F3225 - Standard Guide for Characterization and Assessment of Vascular Graft Tissue Engineered Medical Products (TEMPs) is a new standard, now available. F3225-17 developed by Committee F04.44, ASTM BOS Volume 13.02.