Therapeutic Proteins & Peptides Technology Transfer

Technology transfer is the most critical step in the transition of therapeutic protein and peptide biopharmaceuticals from research and development (R&D) to commercial production (industrialization). Smooth technology transfer is critical to the success and rapid launch of drugs. Successful technology transfer requires careful planning, proper documentation and procedures, and experienced experts to help guide process execution and avoid pitfalls. CD Formulation has a dedicated technology transfer service team that leverages its proven expertise in therapeutic protein and peptide science and manufacturing to seamlessly migrate your production to global locations with minimal disruption to your business.

What is Technology Transfer & Why is It Needed?

Technology transfer is the formal process of transferring the production of a drug from one facility, scale, or stage of the drug life cycle to another facility, scale, or stage of the drug life cycle. Bio-process technology transfer for proteins and peptides usually includes the transfer of production processes and analytical methods. Transfers can occur at different stages, and the most common ones are:

• Transfer of production processes from the R&D stage to the production stage.
• Transfer of analytical methods from the R&D laboratory to the corporate laboratory.
• Transfer of marketed products between different companies/different production sites.

As drugs develop from the laboratory to commercial production, pharmaceutical and biotechnology companies often need to transfer technology during the life cycle of drugs for different reasons. For example, 1) Changes in production equipment, methods, and materials lead to process differences, and key process parameters need to be optimized, or the entire process needs to be redeveloped, which may require technology transfer. 2) Some companies need technology transfer because they lack the ability and resources to optimize process optimization, secondary packaging, or optimize product life cycle management. 3) When larger batch production and management requirements are required, companies also need technology transfer to scale up or transfer drugs from one commercial sterile manufacturing facility to another.

Fig. 1 Technology transfer possibilities within a product life cycle, from pre-clinical studies to commercialization. (Chattaway T, 2020)

Explore Our Therapeutic Proteins & Peptides Technology Transfer Services

The core of technology transfer is knowledge transfer. At CD Formulation, our team of technology transfer experts has the expertise to ensure efficient technology transfer of your protein and peptide manufacturing processes and that the final process is aligned with your goals, maximizing the efficiency and success of your technology transfer projects. Our team can provide customized solutions whenever any of the following key factors change.

• Equipment changes: This includes process validation or process changes to ensure that the target facility does not have the exact same equipment and models as the transfer facility, without impacting the production process.
• Raw material and consumable changes: This includes raw material and consumable compatibility testing and process redevelopment services.
• Regulatory considerations: This includes revalidating the process running on different equipment.
• Analytical methods validation: This includes performing a variety of characterization tests, release testing, and comparability studies.

Available Proteins & Peptides Technology Transfer Services

Our protein and peptide bioprocess transfer model is unmatched in expertise and professionalism. It covers two key phases to ensure your tool transfer is completed efficiently and accurately.

Fig. 2 Types of therapeutic protein/peptide technology transfer. (CD Formulation)

Technology Transfer From Protein and Peptide R&D to Production

• Process analysis and evaluation report.
• Process technology transfer plan/report.
• Process confirmation experimental batch.
• Scaling model of establishment/transfer process.

Technology Transfer From Protein and Peptide R&D to Quality Control (QC)

• Analytical method evaluation report.
• Analytical method transfer plan/report.
• Analytical method transfer confirmation and validation.

Our Therapeutic Proteins & Peptides Technology Transfer Capabilities

Unparalleled Expertise in Protein and Peptide Biopharmaceuticals

Leveraging our decades of experience and analytical characterization capabilities in protein R&D and production, as well as our successful history of technology and production transfer, our proven processes and dedicated team of experts ensure the seamless execution of large, technically complex projects with minimal disruption.

Perfect Equipment

Our transfer laboratory is well-equipped to efficiently complete technology transfer with customers at any stage of the product development lifecycle. We are able to apply industrial scale-up and scale-down techniques, perform differential analysis for different sites and equipment facilities, and complete technology transfer between different production equipment, production scales, and production platforms.

First-class Process and Manufacturing Technology

We have extensive process unit operation expertise for protein and peptide production. Our team of experts develops control strategies to shorten process validation time and reduce costs throughout the product life-cycle.

Why Choose Us for Therapeutic Proteins & Peptides Technology Transfer?

• Our team of scientists and researchers have extensive experience in developing and manufacturing therapeutic proteins and peptides. We have a deep understanding of the science behind these molecules and can provide valuable insights and guidance throughout the technology transfer process.
• We have state-of-the-art facilities that are equipped with the latest technology and equipment to support the development and manufacturing of therapeutic proteins and peptides. This ensures that the technology transfer process is carried out efficiently and accurately.
• We adhere to strict quality assurance protocols to ensure that the therapeutic proteins and peptides we develop meet the highest standards of quality, purity, and efficacy.
• We work closely with our clients to develop tailored solutions that meet their specific needs and goals. Our flexibility and willingness to collaborate make us a preferred partner for technology transfer projects.
• We have a comprehensive understanding of regulatory requirements for the development and manufacturing of therapeutic proteins and peptides. We can provide regulatory support to ensure that your project meets all relevant guidelines and standards.
• We provide flexible experimental options to meet the needs of different customers.

Publication

The execution of bioprocess technology transfer for therapeutic proteins and peptides is critical to ensure smooth knowledge transfer and maximized process reproducibility. As your most loyal partner, CD Formulation is committed to providing the most professional and efficient bioprocess technology transfer services to ensure the smooth production process of your therapeutic proteins and peptides. Please don't hesitate to contact us if you are interested in our services. We look forward to cooperating with you.

How It Works

STEP 1

Submit a service request describing your specific research or development need.

STEP 2

We'll email you to provide your quote and confirm order details if applicable.

STEP 3

Execute the project with real-time communication, and deliver the final report promptly.