Ensuring Quality from Concept to Regulatory Submission

CMC, chemistry, manufacturing, and control, is required throughout the drug development and manufacturing process for any pharmaceutical or biologic.  Specific manufacturing processes, product characteristics and product testing must be defined in order to ensure that a drug product is safe and effective and ensures batch consistency. It is important to note that CMC requirements vary for different products, including small molecules, large molecules and gene therapy products.  Working with an end-to-end solutions provider is vital to ensure that specific requirements are met throughout the entire process.  Our experts not only understand the process from the initial research stage, but also are savvy with various regulatory requirements for specific products.

From Preclinical to Manufacturing

  • Preclinical: Proper analytical methods are validated to monitor the products, stability testing can be initiated, physicochemical properties are determined, raw materials are selected and tested
  • Clinical: Continued analytical method validation is required, additional characterization of the drug is also required
  • Scale Up: Ensure that larger batches or the product are the same and meet the same specifications as clinical trials
  • Manufacturing: Qualification, lot release and process testing continued

Our Edge

CMIC’s experience for CMC and GMP analytical services includes many achievements from authorities, a proven track record of numerous GMP release tests ranging from physicochemical analysis, microbiological testing and analysis of biopharmaceuticals.

Comprehensive Service Offerings
Full service solutions from analyzing and evaluating the quality of drugs from pre-formulation to commercial manufacturing.  Our GMP analytical services include physicochemical, biochemical and microbiological techniques with FDA accepted quality management system (cGMP), biopharmaceuticals, narcotics, psychotropic and high potency APIs (chemical hazard substances).

Proven Track Record
Our proven track record of numerous GMP release tests include: physicochemical analysis, microbiological testing and analysis of biopharmaceuticals.

CMC and GMP Analytical Services

Small Molecule ServicesLarge Molecule Services
Physicochemical PropertiesBiological/Immunological Activity
Method development, validation of analytical procedures
  • Biochemical measurement
  • Biological measurement: Bioassay (culture cell, animal)
  • Immunological measurement (ELISA, Western blotting, other measurements based on antigen antibody reactions
Stability Testing (for new drug application/post-marketing)Physicochemical Activity
Sample storage under various conditions (Long-term stability testing, Accelerated testing, Stress testings, Photostability testing Zone IV, 5 ℃, -20 ℃, -30 ℃, -85 ℃, etc.)
  • Electrophoresis, Chromatography
  • Spectroscopic property
Acceptance and release testing of drug substances, drug products, and excipientsStructural Analysis
Dissolution test for bioequivalence study
  • Intact protein analysis
  • Peptide mapping
  • Sugar chain structure analysis
  • Sequence confirmation of nucleic acid
Incompatibility TestingImpurity Analysis
Acceptance and release testing of regenerative medicine products
  • Host-cell protein
  • Host-cell DNA
  • Extractable/Leachable

CMC Equipment and Facility Overview

Commitment to providing state-of-the-art equipment and facilities to enable a wide range of testing

Small Molecule Drug Equipment
To meet the equipment-related demands of our customers, we have an extensive array of analytical equipment for general purpose use (such as HPLC, UPLC, GC, etc.) from various makers including Waters Corporation, Agilent Technologies, Shimadzu Corporation, and Dionex Corporation. All analytical equipment is periodically inspected and calibrated to ensure the data.

Large Molecule Testing Equipment
There are a variety of plate readers to perform different types of ELISA for cutting-edge biopharmaceuticals. In addition, we have specific equipment for biopharmaceuticals such as clean bench, safety cabinet, CO2 incubator, automated electrophoresis system, capillary electrophoresis, and circular dichroism spectrophotometer.

Facility Overview

Facility Name

Description
Stability Test Chamber Facility

Sizes of our walk-in stability test chambers are all more than 16.5 square meters and meet the various conditions requested by ICH guidelines. The chambers have enough spaces for large volume infusions and dialysis fluid. Typical storage conditions are long-term stability testing (25℃/60%RH), accelerated testing (40 ℃/75%RH), intermediate-term stability testing (30 ℃/65%RH), Zone IV long-term stability testing (30 ℃ /75%RH), long-term refrigerated storage testing (5 ℃), long-term/accelerated stability testing for drug products packaged in semi-permeable containers (25 ℃/40%RH, 40 ℃/≤25%RH).

We also have small stability test chambers for heat stress testing (5 ℃ to 130 ℃), humidity stress testing (available for low humidity conditions such as 25 ℃/31%RH, 50 ℃/10%RH), photostability testing (Option 1, Option 2), frozen storage testing (-20 ℃ to -30 ℃), deep-frozen storage testing (-85 ℃) and so on to perform test under the several conditions simultaneously.

All storage chambers, refrigerators, and freezers are connected to independent electric generators, and in case of power failure, the electric supply would be re-established within a minute.

We build a backup system for unexpected emergencies by installing the central monitoring system, independent electric generator, water tank, and backup chambers.

Microbiological Testing FacilitySterility test room and microbiological test room are maintained clean environment by checking air cleanliness (wind speed, air volume, ventilation rate, and cleanliness) and airborne bacteria at appropriate intervals.
Cell Culture Testing RoomBioassay using cultured cells study (Cell Based Assay) is performed by the trained scientist in the BSL2 cell culture room where the container of liquid nitrogen for cell preservation is completed.
Chemical Hazard RoomPass box and HEPA filters prevent chemical hazard material from diffusing to outside of the room. There are the glove box and draft chamber in the Chemical Hazard Room to meet various testing items. Safety of scientists is secured by protective clothing and equipment, and standardized procedures by SOP.

Non-Clinical Studies

Laboratory

CMC Consulting Services

Consulting Services