Analytical Method Development and Validation for Pharmaceutical

Process Analytical Science

Our process analytical sciences group provides support for research, development and commercial production.

At Medicilon, the importance of analytical support in pharmaceutical development and manufacturing is well understood. We provide our clients with analytical method development and all other services required to support their regulatory needs.

Services Offered

Analytical Method Development, Qualification and Validation For
- Assay
- Related Compounds
- Water Content
- Chiral Analysis
- Residual Solvents
- Trace Metals Analysis

IPC and Release Testing
Impurity Isolation and Structure Elucidation
Reference Standard Qualification
Stability Studies
PGI Method Development, Validation and Testing
Specification and Other Regulatory Filing Documentation Preparation

We have the following key instrumentation to support our analytical activities

Chromatography: UPLC, HPLC, LC-MS, GC, GC-HS
Solid State Characterization: DSC, TGA, XRPD, PSD, Polarized Light Microscopy
Elemental Analysis: ICP-OES
Identification: NMR, FT-IR
General Testing: KF, UV-Vis, Polarimeter

Analytic method development, validation and transfer are key elements of any pharmaceutical development program. This technical brief will focus on development and validation activities as applied to drug products. Often considered routine, too little attention is paid to them with regards for their potential to contribute to overall developmental time and cost efficiency.

analytical method development Methods are developed and validated to analyze in-process, finished product and stability samples, as well as swabs to verify the cleanliness of manufacturing equipment.

Typically, methods for in-process, uniformity of dosage units and dissolution sample analysis are developed and validated using UV, HPLC, UPLC, or GC procedures.

Methods used to perform chemical assay, identification, related substances/impurities or chiral purity testing on API and finished drug product are typically developed and validated using HPLC, UPLC or GC.

Methods developed for stability sample analysis are validated to ensure they are stability indicating.

All validations are performed according to FDA-ICH guidelines, client-approved protocols and standard operating procedures.

Method Validation

By working with Medicilon, you gain an experienced partner with a good working knowledge of method validation requirements suitable for different phases of development. To ensure methods meet regulatory requirements, we follow relevant ICH guidelines such as ICH Q2(R1) or compendia guidance in combination with client-specific protocols.

Analytical Techniques and Capabilities Include:

UV/VIS Spectroscopy
Fluorescence Spectroscopy
ELISA
SDS-PAGE
Iso-electric Focusing
Capillary Gel Electrophoresis
UPLC
HPLC
Atomic Adsorption
FTIR
Peptide Mapping
Carbohydrate Analysis
Cell Based Assays

HPLC Methods: HPLC methods with variety of high resolution analytical columns represent the most effective and efficient means of monitoring various degradation of protein therapeutics.

Size-Exclusion Chromatography
Ion-Exchange Chromatography
Reversed Phase Chromatography
Hydrophobic Interaction Chromatography
Various Detectors: UV, Fluorescence, Reflective Index, Evaporative Light Scattering, Mass Spectrometry

The wide variety of equipment, columns, eluent and operational parameters involved high performance liquid chromatography (HPLC) method which makes the development seem complex. Following steps:
step 1 – Selection of the HPLC Method and Initial System
step 2 – Selection of Initial Conditions
step 3 – Selectivity Optimization
step 4 – System Optimization
step 5 – Method Validation

Structural Analyses: Measure the secondary, tertiary, and quaternary structure of biologically active proteins

Circular Dichroism
Fourier Transformed Infrared Spectroscopy
Fluorescence Spectroscopy
Differential Scanning Calorimetry

Electrophoresis: Separation of impurities based on both charge and mass makes electrophoresis an excellent orthogonal method

Capillary Electrophoresis (CE)
Sodium Dodecyl Sulfate Electrophoresis (SDS-PAGE)
Protein Analyzer

Contact Us

Email : marketing@medicilon.com
Tel : +86 021 58591500

Tips : Above is part of analytical method development, analytical method development and validation for pharmaceutical. You can also CONTACT US with any question or enquiry you may have. We will be happy to discuss your needs in detail and design an appropriate plan of action.

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Inventory of the three major in vitro pharmacokinetic research methods

The metabolic properties of a compound are an essential factor in whether or not it can be used as a drug in the clinical setting, so pharmacokinetic studies of newly synthesized compounds are required in drug development. In vitro incubation with liver microsomes, recombinant CYP450 enzyme lines, and in vitro incubation with hepatocytes are some of the more common in vitro drug metabolism methods. 1. In vitro incubation method with liver microsomes The metabolic stability and metabolic phenotypes of candidate compounds in different species of liver microsomes are good predictors of the metabolic properties of compounds in vivo. They are practical tools for evaluating candidate compounds in the pre-development phase of drug development. Liver microsomes include rat liver microsomes, human liver microsomes, canine liver microsomes, monkey liver microsomes, and mouse liver microsomes. In in vitro incubation of the liver, microsomes are the "gold standard" for in vitro d

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Novel Parkinson’s Therapies Possible with New Mouse Model

Parkinson's disease (PD) is a neurodegenerative disorder that is marked by the accumulation of the protein, α-synuclein (αS), into clumps known as Lewy bodies, which diminish neural health. Now, researchers from Brigham and Women's Hospital (BWH) report the development of a mouse model to induce PD-like αS aggregation, leading to resting tremor and abnormal movement control. The mouse responds to L-DOPA, similarly to patients with PD. The team's study (“Abrogating Native α-Synuclein Tetramers in Mice Causes a L-DOPA-Responsive Motor Syndrome Closely Resembling Parkinson’s Disease”) on the use of this transgenic mouse model appears in Neuron . “α-Synuclein (αS) regulates vesicle exocytosis but forms insoluble deposits in PD. Developing disease-modifying therapies requires animal models that reproduce cardinal features of PD. We recently described a previously unrecognized physiological form of αS, α-helical tetramers, and showed that familial PD-causing missense mutati

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