Business Inquiry
Global:
Email:marketing@medicilon.com
+1(626)986-9880(U.S. - West Coast)
0044 7790 816 954 (Europe)
China:
Email: marketing@medicilon.com.cn
Tel: +86 (21) 5859-1500
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.
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
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.
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.
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.
UV/VIS Spectroscopy
Fluorescence Spectroscopy
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
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.