ACM Pharma
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Contact
30-36, avenue du 21 août 1944
45270 Bellegarde
France
Directeur Commercial
About us
ACM PHARMA (a part of TERANGA Group) is a CRO and reference partner of the bio/pharmaceutical industry for contamination control. Our objective is to bring you the best adapted solutions for each stage of your development, validation, suitability and/or QC test of Raw material, Drug substance or Drug Product in GMP, GMP like or R&D conditions.
Our expertise and our latest generation equipment allow us to carry out many bio/testing methods (microbiology, molecular biology, immunoessay) on bio/pharmaceutical products (vaccines, monoclonal antibodies, cell and gene therapy products, etc.) according to Pharmacopoeias, ICHQ2 R1 recommendations and other tailor-made methods conditions.
OUR VISION : Be a reliable and available partner, beyond a standard customer-supplier relationship
OUR MISSION : Provide technical and regulatory solutions during the different phases of development and control of your products
OUR VALUES : Alongside a customer oriented mindset, our proactivity and the development of our teams are key assets for the success of your projects
Business offer
Microbiology :
• Sterility test according to Ph Eur, chap 2.6.1 & USP <71>
• Bioburden according to Ph Eur, chap 2.6.12, 2.6.13 & USP <61>, <62>
• Purity, viability test
• Bacterial Endotoxins Tests Ph Eur, chap 2.6.14, & USP <85> & Ph Eur, chap 2.6.32, & USP <86>
• Microbial identification (MS Maldi TOF, MicroSeq)
Molecular biology and immunoessay :
• Detection of mycoplasma by qPCR according to Eur Ph, chap 2.6.7 & USP <63>
• Quantification of nucleic acids (DNA, RNA)
• Residual DNA and residual protein detection
• Detection of contaminants (bacteriophages, virus, pathogen, etc.)
• Quantitative detection of impurities or residues (ELISA)
• Determination of total proteins according to Eur Ph 2.5.33
• Purity of protein SDS-PAGE
• Implementation of custom method
Many other molecular biology tests are available to detect a wide range of contaminants in your biological samples.
Contat Information :
Eric Petat, Scientific Director
eric.petat@terangagroupe.com
+33 2 38 90 41 01
Activities
- Service
- CMC
- GLP compliance
- Master Cell Bank
- Analytical development
- Quality assurance, quality control & analytical process
- Cell line analytical development
- Contaminants detection
- Biosafety & Bioanalysis
- Impurities detection
- Bioproduction analytical test
- Monitoring
- Characterization
- Batch consistency
- Batch release test
- Chemical, physical, biological test
- Quality control test support
- Post-production test
- Real-time stability test
- CMC/analytical quality assessment, quality control
- Cross contamination
- Sterility
- Contaminants detection
- Bioproduction/CMC/Analytical Quality Assessment, Quality Control
- Non-GMP pilot batch
- GMP batch
- CGMP
- Sterility
- Quality control
- Contaminants detection
- Non-clinical safety and toxicology studies
- CMC
- GMP compliance
- Master Banks (cell and viral as needed)
- Characterization and testing
- Cell Culture / Fermentation
- Ability to work in BSL2 conditions
- Quality control & analytical process monitoring
- Biosafety & Bioanalysis
- Viral safety
- Bioproduction analytical monitoring
- Key and critical process parameters (KCP, CPP)
- Identification
- Monitoring
- Batch release test
- Chemical, physical, biological testing
- Potency assay
- Impurities detection
- Quality control test support
