Trusted Partner for Flexible & Scalable
Custom Protein Manufacturing

Custom protein services: Advancing your recombinant protein manufacturing goals

In the realm of recombinant protein manufacturing, every project is crafted as a bespoke solution to meet the precise scientific and clinical objectives of our clients. From initial construct design and process development to comprehensive analytical testing and protein characterization, each step presents distinct challenges requiring made-to-order solutions. To successfully produce custom therapeutic and diagnostic proteins, partnering with a CDMO that prioritizes customization is essential. We deliver a full spectrum of capabilities designed to address your specific protein expression and purification service needs.

Key features of our custom protein services include:

• Flexible process development and seamless technology transfer of existing manufacturing methods.
• Dedicated project management teams ensure effective communication and timeline adherence.
• Custom assay development supporting product release testing aligned with regulatory standards.
• Product-specific quality control analyses to meet stringent compliance requirements.
• Tailored manufacturing batch records for each recombinant protein produced.
• Progressive quality levels catering to research-grade, diagnostic, and cGMP protein manufacturing demands.

Partnering with Aldevron for cGMP protein manufacturing excellence

With decades of experience in recombinant protein production, Aldevron offers unparalleled expertise across small- and large-scale projects. Our state-of-the-art, controlled-environment facilities uphold rigorous validation protocols to guarantee protein quality, purity, and consistency. Our newly expanded facility is equipped for immediate project initiation, supporting your timelines from research through clinical and commercial stages.

Our commitment to quality and regulatory compliance includes:

• A range of expression systems and purification methods to guarantee the success of your project.
• Agile scalability tailored to project-specific requirements, ensuring timely delivery.
• Extensive expression services offering access to top-tier reagents and analytical technologies from our vast product portfolio.
• Proven track record navigating regulatory frameworks and documentation processes.
• Dedicated project management focused on efficient process execution and clear communication.
• Consistent high-quality protein production, batch-to-batch, to support successful therapeutic protein development.
• Purpose-built facilities designed to support protein manufacturing from early-stage research to cGMP-compliant commercial production.

Comprehensive development and manufacturing process

Our multidisciplinary team, including customer-support specialists, project managers, and senior scientists, collaborates closely with clients to devise strategic development plans. This ensures that recombinant protein production workflows are optimized for the intended application. Following method development and process optimization, clients can scale manufacturing in our ISO 13485-certified, cGMP-compliant facilities, depending on product specifications and regulatory requirements.

Transfer of existing protein manufacturing processes

Clients with established protein-manufacturing protocols for clinical, diagnostic, and commercial applications may transfer their processes to Aldevron. Our subject matter experts in protein manufacturing and process optimization work collaboratively to facilitate smooth transitions. Optimization recommendations are provided to enhance process efficiency and ensure manufacturing readiness. Aldevron’s rigorous internal validation guarantees the successful execution of both engineering and cGMP protein manufacturing runs.

The Aldevron advantage: Agility and customized solutions for recombinant protein production

A trusted partner accelerates project progression by integrating best practices and offering flexible manufacturing strategies. We collaborate closely with clients to develop detailed statements of work aligned with their specifications and realistic deadlines. Whether your focus is on upstream protein expression service, downstream protein purification, or analytical testing, our experienced team supports your project from preclinical research through full cGMP protein manufacturing.

Upstream protein expression expertise

• Construct design, including codon optimization and custom gene synthesis.
• Generation and full characterization of cGMP master cell banks.
• Scalable process design and optimization using advanced single-use fermentation technologies.

Downstream protein purification services

• Development, optimization, and scale-up of chromatographic purification techniques using media and membrane formats.
• Implementation of scalable, innovative purification technologies to maximize process efficiency and yield.

Comprehensive analytical services

In addition to standard assays, we offer custom assay development to meet specific product release and quality control needs:

Let’s bring your project forward.

At Aldevron, we advance your recombinant protein manufacturing goals with tailored solutions, cutting-edge facilities, and unwavering quality. From construct design to cGMP production, our expertise ensures success at every stage. Whether for therapeutic, diagnostic, or research-grade proteins, Aldevron is your trusted partner for scalable, high-quality production.