As an enterprise focusing on the pharmaceutical field, Profacgen has a leading CDMO platform and is committed to providing one-stop professional services from drug discovery to cGMP production for global biopharmaceutical and biotechnology companies.
The technology transfer team has established a comprehensive and refined technology transfer process and mainstream equipment parameter conversion model, and implemented comprehensive risk control in the process of technology transfer, which can quickly adapt to and meet the production needs of different users and ensure the transfer and production of customer projects. We have established perfect standard management procedures for technology transfer, conducted multi-dimensional gap analysis and risk assessment, and formulated risk reduction measures. Whether we transfer from the customer to us or from us to the customer, we can ensure the successful transfer of the process.
Profacgen's cGMP production workshop is designed and built in strict accordance with the current regulations and guidelines of the United States and the European Union. It has the highest standard quality system, a complete quality management system and an experienced quality management team, which can effectively meet the requirements of global regulations for biological product production facilities.
GMP production service milestones and delivery standards:
| Milestone | Service | Delivery |
| Transfer and confirmation of analytical methods | Transfer and confirmation of key central control testing methods and release testing methods | The analysis method completes the transfer according to the predetermined scheme |
| Cell line transfer and QC tests | MCB and WCB transfer Mycoplasma and sterility test |
Complete the transfer according to the agreed standard and time |
| Fermentation and purification process transfer and validation | Transfer confirmation of cell culture and purification process: risk assessment, narrowing the model, establishing a batch (3L / 10L) of engineering batch to verify the transfer process | Repeat the production process to obtain products that meet the quality requirements |
| 50L amplification confirmation | One batch of 50L process amplification | |
| Release of raw materials and consumables (culture medium, feed supplement, filler, packaging material, supplementary material, etc.) | Purchase and release according to the customer's project bill of materials and release standards | All raw and supplementary material shall be purchased and released according to their own standards |
| Stock solution GMP document establishment (SOP and batch record) | Preparation of GMP documents, including process procedures, SOP, batch records and training records | Comply with relevant requirements of GMP document system |
| Stock solution production meeting cGMP requirements | A batch of stock solution production meeting cGMP requirements | The production complies with GMP quality management specifications, and the samples are tested as qualified according to the standards |
| Stock solution batch release test | Stock solution batch release test | Complete release inspection according to GMP quality management specification |
| Preparation GMP document establishment (SOP and batch record) | Preparation of GMP documents, including process procedures, SOP, batch records and training records | Comply with relevant requirements of GMP document system |
| Aseptic filling | Simulated filling of culture medium Filling of a batch of sterile water agent |
The production complies with GMP quality management specifications, and the samples are tested as qualified according to the standards |
| Finished product release inspection | Stock solution batch release test | Complete release inspection according to GMP quality management specification |
With gene to cGMP, we can help you achieve faster time to market, lower manufacturing costs, and save your promising drug candidates. Profacgen looks forward to cooperating with you.
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