Our clinical batch manufacturing service<\/strong><\/h1><\/div><\/div><\/div><\/div>Are you looking for an industrial partner to manufacture a drug clinical batch<\/strong> ? CDM Lavoisier has been manufacturing injectable drug batches<\/a> for third parties for many years. We have the know-how and industrial capacity to produce clinical batches.<\/p>\n<\/div><\/div><\/div><\/div><\/div><\/div>![\"GMP](\"https:\/\/www.lavoisier.com\/wp-content\/uploads\/2021\/11\/Gamme-produits-et-services-CDM-Lavoisier.jpg\" "\\"Gamme")
<\/span><\/div><\/div><\/div><\/div><\/div>What is a clinical batch?<\/h2><\/h2><\/div>A drug product clinical batch manufacturing<\/span><\/span><\/span> is related to the production of a small batch<\/strong> used in a clinical trial. The laboratory manufactures a quantity of finished product ranging from a few hundred to a few thousand units, specifically to meet the needs of a clinical study carried out on a limited cohort of patients.<\/p>\nThe clinical batch follows the same manufacturing process<\/strong> as a pilot batch<\/a> or industrial batch. It complies with the same quality standards and regulations to guarantee patient safety.<\/p>\n<\/div><\/div><\/div><\/div><\/div><\/div>![\"Pharmaceutical](\"https:\/\/www.lavoisier.com\/wp-content\/uploads\/2021\/12\/faconnage-flacon.jpg\" "\\"faconnage-flacon\\"")
<\/span><\/div><\/div><\/div><\/div><\/div>Steps in manufacturing a clinical trial batch<\/h2><\/div>The manufacturing steps for a batch of injectable drug intended for a clinical study are as follows :<\/p>\n
\n- Sourcing of components and raw materials ;<\/li>\n
- Quality control of these components and raw materials ;<\/li>\n
- Solution preparation ;<\/li>\n
- Solution filling ;<\/li>\n
- Terminal sterilization ;<\/li>\n
- In-process and finished product quality control ;<\/li>\n
- 100% visual inspection ;<\/li>\n
- Product packaging with appropriate labeling (anonymization) ;<\/li>\n
- Batch release ;<\/li>\n
- Traceability of operations in the batch file.<\/li>\n<\/ul>\n
Our factory has the necessary authorizations to manufacture medicines for human use in accordance with Good Pharmaceutical Manufacturing Practice (GMP) :<\/p>\n
\n- EU-GMP<\/li>\n
- ISO 13485<\/li>\n<\/ul>\n<\/div><\/div><\/div><\/div><\/div><\/div>
![\"CDMO\"](\"https:\/\/www.lavoisier.com\/wp-content\/uploads\/2023\/07\/Developpement-solutions-injectables-CDM-Lavoisier.jpg\" "\\"D\u00e9veloppement-solutions-injectables-CDM-Lavoisier\\"")
<\/span><\/div><\/div><\/div><\/div><\/div>Placebo manufacturing<\/h2><\/div>CDM Lavoisier is also able to manufacture the placebo to be used in a double-blind comparative study on drugs in liquid form. Here are just a few examples of solutions we can manufacture for use as a placebo :<\/p>\n
\n- water for injection ;<\/li>\n
- sodium chloride 0,9% ;<\/li>\n
- glucose.<\/li>\n<\/ul>\n<\/div><\/div><\/div><\/div><\/div><\/div>
![\"Contract](\"https:\/\/www.lavoisier.com\/wp-content\/uploads\/2022\/01\/etude-stabilite.jpg\" "\\"etude-stabilite\\"")
<\/span><\/div><\/div><\/div><\/div><\/div>Services ancillary to clinical batch production<\/h2><\/div>In addition to batch manufacturing, we can also support you in the development of industrialization processes, or the validation of processes and methods. We also carry out stability studies<\/a>. Lastly, we offer product blinding via a specialized partner.<\/p>\nThese services are available for products in glass vials, glass ampoules and plastic ampoules (BFS).<\/p>\n<\/div>
Are you looking for an industrial partner to manufacture a drug clinical batch<\/strong> ? CDM Lavoisier has been manufacturing injectable drug batches<\/a> for third parties for many years. We have the know-how and industrial capacity to produce clinical batches.<\/p>\n<\/div> A drug product clinical batch manufacturing<\/span><\/span><\/span> is related to the production of a small batch<\/strong> used in a clinical trial. The laboratory manufactures a quantity of finished product ranging from a few hundred to a few thousand units, specifically to meet the needs of a clinical study carried out on a limited cohort of patients.<\/p>\n The clinical batch follows the same manufacturing process<\/strong> as a pilot batch<\/a> or industrial batch. It complies with the same quality standards and regulations to guarantee patient safety.<\/p>\n<\/div> The manufacturing steps for a batch of injectable drug intended for a clinical study are as follows :<\/p>\n Our factory has the necessary authorizations to manufacture medicines for human use in accordance with Good Pharmaceutical Manufacturing Practice (GMP) :<\/p>\n CDM Lavoisier is also able to manufacture the placebo to be used in a double-blind comparative study on drugs in liquid form. Here are just a few examples of solutions we can manufacture for use as a placebo :<\/p>\n In addition to batch manufacturing, we can also support you in the development of industrialization processes, or the validation of processes and methods. We also carry out stability studies<\/a>. Lastly, we offer product blinding via a specialized partner.<\/p>\n These services are available for products in glass vials, glass ampoules and plastic ampoules (BFS).<\/p>\n<\/div><\/span><\/div><\/div>What is a clinical batch?<\/h2><\/h2><\/div>
<\/span><\/div><\/div>Steps in manufacturing a clinical trial batch<\/h2><\/div>
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<\/span><\/div><\/div>Placebo manufacturing<\/h2><\/div>
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<\/span><\/div><\/div>Services ancillary to clinical batch production<\/h2><\/div>