Technology Transfer
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Mycenax accelerates your product’s journey through seamless, end-to-end technology transfer driven by our expert MSAT team. By integrating process development with GMP expertise, we de-risk scale-up and ensure precise execution from lab to commercialization, enabling faster time-to-market. Our structured program supports smooth transitions at any lifecycle stage, leveraging proven strategies to ensure process fit and mitigate risk. Whether scaling up or executing site-to-site technology transfer, we are your dedicated partner for manufacturing success. |
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The Hub of Technology Transfer: |
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Bridging the Gap from Lab-Scale to Commercial Production |
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| Service Highlights | ||||||
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| Proven Compliance | Flexible Process Manufacturing | Dual-Departmental Expertise | ||||
| Successfully passed EMA, PMDA, Health Canada, MHRA and MFDS GMP inspections |
Expert manufacturing for diverse modalities, including mAbs, recombinant proteins, and bi/multi specific mAbs from 25 L to 2,000 L |
A team with 10+ years of hands-on experience in both PD and GMP sectors, ensuring seamless project execution | ||||
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5-Stage Technology Transfer Program |
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Our structured program is designed to mitigate risks early, ensuring a complete process fit before final execution. |
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Site-to-Site Technology Transfer |
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Mycenax accelerates the technology transfer process through a standardized documentation platform and extensive expertise in risk assessment and mitigation studies. We ensure absolute process consistency and strict regulatory compliance—even for complex 2,000 L parallel transfers—by leveraging proactive risk management and providing seamless, fully-supported technical transitions. |
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Scale-Up Capabilities & Performance |
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With a track record of over 40 successful projects, we specialize in the complex scale-up of diverse modalities—including mAbs, recombinant proteins, and bi/multi specific mAbs. Our expertise ensures seamless process integration across all scales from 5 L to 2,000 L, maintaining long-term stability throughout the product lifecycle. |
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USP Protein Yield Performance Achieving consistency of 100± 15% |
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DSP Step Recovery Maintains ± 5% consistency compared to small scale process |
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Mycenax accelerates your product’s journey through seamless, end-to-end technology transfer driven by our expert MSAT team. By integrating process development with GMP expertise, we de-risk scale-up and ensure precise execution from lab to commercialization, enabling faster time-to-market. Our structured program supports smooth transitions at any lifecycle stage, leveraging proven strategies to ensure process fit and mitigate risk. Whether scaling up or executing site-to-site technology transfer, we are your dedicated partner for manufacturing success. |
||
|
The Hub of Technology Transfer: |
||
|
Bridging the Gap from Lab-Scale to Commercial Production |
||
|
||
| Service Highlights | ||
|
||
| Proven Compliance | ||
| Successfully passed EMA, PMDA, Health Canada, MHRA and MFDS GMP inspections | ||
|
||
| Flexible Process Manufacturing | ||
|
Expert manufacturing for diverse modalities, including mAbs,recombinant proteins, and bi/multi specific mAbs from 25 L to 2,000 L |
||
|
||
| Dual-Departmental Expertise | ||
|
A team with 10+ years of hands-on experience in both PD and GMP sectors, ensuring seamless project execution |
||
|
5-Stage Technology Transfer Program |
|
Our structured program is designed to mitigate risks early, ensuring a complete process fit before final execution. |
 |
 |
 |
|
Site-to-Site Technology Transfer |
|
|
|
Mycenax accelerates the technology transfer process through a standardized documentation platform and extensive expertise in risk assessment and mitigation studies. We ensure absolute process consistency and strict regulatory compliance—even for complex 2,000 L parallel transfers—by leveraging proactive risk management and providing seamless, fully-supported technical transitions. |
|
|
|
Scale-Up Capabilities & Performance |
|
|
|
|
With a track record of over 40 successful projects, we specialize in the complex scale-up of diverse modalities—including mAbs, recombinant proteins, and bi/multi specific mAbs. Our expertise ensures seamless process integration across all scales from 5 L to 2,000 L, maintaining long-term stability throughout the product lifecycle. |
|
|
USP Protein Yield Performance Achieving consistency of 100± 15% |
|
DSP Step Recovery Maintains ± 5% consistency compared to small scale process |
|
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| “Technology transfer is just the beginning. Mycenax partners with you throughout the product lifecycle to ensure long-term stability and sustained manufacturing excellence." | ||||