- Aldevron has expertise with:
- Construct design
- Codon optimization and gene synthesis
- Fully characterized GMP master cell banks
- Scalable process design and optimization.
- Utilization of single-use fermentation technologies to reduce the risk of cross-contamination.
Protein/Enzyme Development and Manufacturing Services
Custom Protein at Scale for Research, Diagnostics, and Therapeutics
- Flexible process development and tech-transfer of existing methods
- Dedicated project management team
- Custom assay development that supports product release testing
- Product-specific quality control analysis
- Client-specific master batch records
Each client project begins by defining goals and identifying potential risks. Next, we engineer a solution to meet your required specifications, from new method development or technical transfer. We are ready to service your needs and be your trusted, long-term partner for a range of applications, such as gene editing CRISPR nucleases, RNA in vitro transcription and capping enzymes, recombinant proteins for viral packaging, antibodies, or peptides, and much more.
We have an experienced team of dedicated client support specialists, project managers and senior scientists to create a plan and guide product development work, ensuring that the methods are suitable for the client’s application. Process optimization ensures a seamless transition to our manufacturing group. Once development is complete, clients may elect to scale manufacture of products in either our ISO 13485 certified facility or cGMP facility.
Transfer of Existing Process
Clients interested in protein manufacturing in support of clinical, diagnostic, and commercial applications have the option of transferring an existing process into Aldevron. Clients choosing to transfer an existing method will engage with Aldevron’s protein manufacturing SMEs. Process optimization may be recommended to ensure a seamless transition. Regardless of the path taken, Aldevron’s internal manufacturing readiness process ensures the successful transition and execution of both the engineering and manufacturing runs.
The Aldevron AdvantageA good partner can help keep a project moving forward by sharing best practices and working with their clients on flexible manufacturing strategies to meet your therapeutic and diagnostic product needs. We can put together a detailed statement of work that adheres to a client’s specifications while sticking to a realistic deadline. Whether you have interests in protein upstream and downstream processing or analytical services, our experienced team of professionals can work with you through every step from pre-clinical to GMP.
Talk with our experts
Interested in working together or have questions about our products and services? Reach out to our client relations team to learn more about what we offer and how to get started on your next project.