Biopharmaceutical
ACM Pharma offers a combined range of microbiology, virology, and molecular biology analyses, covering all requirements related to CMC (Chemistry, Manufacturing, and Controls) aspects—from the development cycle through to GMP stages of clinical and commercial production of biopharmaceutical products.
Our services related to biopharmaceutical products (monoclonal antibodies, vaccines, recombinant proteins, gene therapy medicinal products, and cell therapy medicinal products, etc.) include testing of:
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Finished products and active substances,
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Production intermediates,
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Raw materials,
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As well as the production environment and utilities (water, compressed air, medical air).
Services Provided
| Test Category | Test | Techniques | Services |
|---|---|---|---|
| General Characteristics | Appearance | x | |
| pH | pH meter | x | |
| Osmolality | Osmometer | x | |
| API Concentration | Protein content | A280 | X |
| Identity | Charge profile (cIEF) | Electrophoresis | x |
| CE-SDS | Electrophoresis | x | |
| Purity | Size exclusion (SEC-UV) | Chromatography | x |
| Process-related Impurities | Protein A | ELISA | X |
| Residual DNA (rDNA) | qPCR | X | |
| Host Cell Proteins (HCP) | ELISA | X | |
| Microbiology | Endotoxin | LAL | X |
| Bioburden | Bacteriology | X | |
| Mycoplasma | qPCR | X | |
| Mycobacteria | qPCR | X | |
| Phage Detection | X | ||
| Viral Safety | Virus Detection | qPCR/PCR | X |
x : Services provided by our sister company Cebiphar.
X : Services provided by ACM Pharma.
This table provides a non-exhaustive overview of analyses available for a biopharmaceutical drug.
Microbial identification
For a good control of your microbiological contaminations you are looking for : An efficient identification...
Microbial contamination
Development, validation, transfer, method applicability and microbiological control of raw materials, bulks...
Sterility test
For optimal control of your aseptic productions, ACM Pharma offers a full range of services in accordance with BPF / GMP...
Bacterial endotoxins
Development, validation, transfert, suitability method and bacterial endotoxins testing
Rapid Microbiological Methods
Development, validation, transfer, applicability of methods and microbiological control in rapid and alternative methods.
Antiseptic & disinfectant testing – microbiology
Antiseptic and disinfectant activity test (standardized tests or according to your own protocols)
Microbiological & physicochemical analysis of water
Microbiological & physicochemical analysis of water
Molecular biology and biotesting
Development, validation, transfer, method applicability and biopharmaceutical products.
Cleaning validation
Overall control of the cleaning and disinfection processes of your premises and equipment...
Physico-chemical analyzes
Each preservative system or solar filter can be used at a certain concentration whose limit is...
