Medicilon has been offering high quality analytical testing services to the pharmaceutical industry for decades. We offer a wide range of quality control testing services to support drug research, registration and production. Biopharmaceutical companies also use many of the same services and Medicilon has also added new services to accommodate their unique needs (detailed in the following section).
We perform a variety of tests that are client-specific, particularly in the area of analytical chemistry. Please inquire for more information about additional tests we perform that may not be listed in this brochure.
Laboratory Services
GLP and GCP Bioanalytical Services & Biomarkers
GMP and CMC Laboratory Services
Pharmaceutical Analysis, Stability and Formulation Development Extractables/Leachables Packaging Support
Process Development and Manufacturing Analysis Support
Bioanalytical Services
Our teams are adept in method development,method validation and transfer of efficient and accurate methods which are optimized for your compound. Projects are assigned to and managed by experienced Principal Investigators with support from teams of Project Managers, Project Coordinators, Senior Scientists and Chemists. We provide:
• Bioanalysis for Large and Small Molecules
• Immunogenicity & Neutralizing Antibody Assays
• Antibody Drug Conjugate (ADC) LC-MS and Immunochemistry Services
• Long History of Bioanalytical Support for Biosimilar Drug Development
• Post Marketing Antidrug Antibody (ADA) assays
• Demonstrated Expertise in Ocular Tissue
GMP and Chemistry, Manufacturing & Controls (CMC) Laboratory Services
• GMP Pharmaceutical Analysis
• Method Development & Validation
• Biopharmaceutical CMC Solutions
• GMP Stability Studies
• GMP Batch Release Testing
• Extractables / Leachables
• Glass Delamination Studies
• Elemental Impurities
• Formulation Development
• Preformulation and Physical Characterisation
• GMP Quality Control Testing
• Reference Standard Certification
• Impurities and Particulates Analysis
• Clinical Trial Supplies Manufacturing Services
• Regulatory Affairs
• GMP Auditing and Supply Chain Assurance
• GMP Training Sessions and eLearning For Staff
ANALYTICAL CHEMISTRY
Medicilon provides the professional expertise and regulatory qualifications necessary to perform analytical testing of raw materials, APIs, finished products, packaging material and medical devices. Well-equipped state-of-the-art laboratories offer comprehensive testing services according to the pharmacopoeia and to customer specifications.
STABILITY STUDIES
With a network of ICH stability storage facilities, we offer an extensive capacity and a range of conditions including climatic walk-in chambers and cabinets as well as freezer storage. Our stability teams provide professionally managed cGMP stability programs for even the most complex of dosage forms including orally inhaled and nasal drug products (OINDP), biopharmaceuticals, medical devices or vaccines.
PREFORMULATION
Our team of chemical and formulation development scientists work together to fully understand the physiochemical properties of your drug substance prior to formulating an optimum drug product for clinical supplies, using:
• Polymorph Screening, Crystal Engineering & Crystal Form Selection
• Physiochemical Characterization of API
• Excipient Compatibility Studies
NON-GMP DEVELOPMENT
Our non-GMP development services offer you greater flexibility and speed. With a state of-the-art facility, we are able to focus on lab-scale experiments with batch sizes ranging from <1kg up to approximately 5kg scale for most technologies.
With both our non-GMP and GMP facilities residing on the same campus, we can provide a seamless transition between the development and GMP phases of projects in early stage development.
Biopharmaceutical Services
Our thought-leaders have over 12 years of experience in biopharmaceutical development support across a wide range of product types. Our experts provide regulatory led, phase-appropriate, tailored analytical program design and GLP or GMP compliant laboratory services which help you to navigate the challenges of development, regulatory submission and manufacturing.
Biopharmaceutical Development Support
• GLP Preclinical Bioanalysis
• Immunogenicity Studies
• Analytical Program Design
• Structural Characterization (ICH Q6B)
• Physicochemical Properties (ICH Q6B)
• Comparability Studies
• Biosimilar Programes
• Process Residuals Determination
• Product Related Impurities Determination
• Aggregation Studies
• GMP Potency / Cell Based Assays
• Method Development & Validation
• Extractables / Leachables
• GMP Quality Control Testing
• GMP Batch & Final Product Release Testing
• ICH Stability Studies
• Forced Degradation Studies• Drug Delivery / OINDP Expertise
Contact Us
Email : marketing@medicilon.com.cn
Tel : +86 021 58591500
Tips : Above is part of pharmaceutical development services, pharmaceutical product development, pharmaceutical development. 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.
