Our team members are having excellent experience in method development and validation using LC-MS-MS, GC-MS, GC-ECD, GC-TCD-FID , UPLC-PDA-FLD and are expert in the drugs, degraded products, metabolites in biological fluids and formulation. The sophisticated methods of analysis are rapid, precise and sensitive for the analysis of targeted molecules (such as drugs, small molecules, degraded products, active/inactive metabolites, peptides, FAME, BAME, steroids, residual solvent, ethanol, isopropanol, glycerine content..) as per ICH/EPA/FDA guideline. Our analytical facilities include:

• Variety of GLC
• HPLCs
• GC-MS
• LC-MS-MS-Qtrap-4500
• Chemistry Analysis

PDRC has experienced Drug Metabolism, Pharmacokinetics and Toxicokinetics and Preclinical Validation Team, Led by Prof. Dr. Ashok K. Shakya, who have worked on different project with Industrial partners with efficient well-resourced cGCLP accredited company and laboratories. The team has good expertise to evaluate the fate of parent molecules in plasma and different matrixes utilizing experimental animals. We offer expertise in the following areas:

• Pharmacokinetic evaluation of preclinical plasma samples
• Pharmacokinetic and toxicokinetics evaluation of samples.
• In-vitro biotransformation and identification of metabolites.

Our pharmaceutical formulation development activities are focused on enhancing stability, compatibility and effective delivery of active molecules. We are expertise in pre-formulation analysis, compatibity studies, and pharmaceutical formulation development like thermo- sensitive gels, mucoadhesive gels, ODT containing small molecules from synthetic or natural sources. F&D also offers development of transdermal drug delivery systems and novel drug delivery system (liposome/ niosomes) and their stability studies as per recent ICH guidelines. F&D facilities include:

• Malvern Particle size and Zeta Potential (ZS90);
• Hanson’s Automated Robotic Franz Cell Diffusion System,
• Freeze Dryer,
• HPLC,
• Stability chambers (-5◦C to 80◦C),
• Humidity Controlled Chambers,
• LiposoFast Liposome Factory,
• 164◦C/ -80◦C/ -22◦C Deep Freezers.
• Erweka Pilot Machines
• DR and DT instruments
• Vertical and Horizontal Laminar Air flow
• Fluorescent Microscope

We have expertise in a range of areas including:

• Small Molecule and Small Peptide synthesis
• Improving pharmaceutical properties
• Structure identification
• Multiple step synthesis
• Computer aided drug design
• Lead optimization

Our facilities include:

• Biotage Microwave synthesizer
• Biotage Alstra-Peptide Synthesizer
• FT-NIR-IR, FT-IR
• HPLC/GCs
• UV-Vis Kits

We offer the following clinical support:

• Access to Cancer Research UK Clinical Centre at St James's University Hospital, Leeds
• Dedicated Cancer Research UK clinical research ward and clinical research team
• Close collaboration between early phase clinical team in Leeds (ECMC)
• Tumour specific phase I and II studies conducted with lead tumour type clinician
• GCLP Pharmacology Laboratories

The Molecular Biology Laboratory’s (MBL) primary goal is to provide services, solutions and support to local and global biopharmaceutical and biotechnology companies as well as clinical, research and academic institutions. We can provide you with the following services:

• In vitro and in vivo drug preclinical validation.
• Development of PCR, qPCR and digital droplet PCR (ddPCR) analytical procedures.
• Validation of qPCR analytical procedures.
• Extractions, quantification and analysis of nucleic acids (DNA, RNA, cell-free DNA).
• Biological properties including but not limited cell proliferation, invasion, migration, colony formation and adhesion assays.
• Transfection of expression vectors in different model systems.
• Cloning of cDNA into different expression vector such as human, mouse and insect expression vectors.
• Development of ELISA assay and validation the procedures.
• Site-directed mutagenesis
• plasmid DNA preparation
• Cell Culture Optimization
• Cell Death Testing
• Gel Electrophoresis Testing
• Gene Expression Testing
• Immunocytochemistry Testing
• PCR Amplification, QPCR Testing
• Restriction Digest mapping
• Restriction Enzyme Testing
• Subcellular Localization
• Subcloning
• Tissue Analysis Testing