Therapeutic Proteins & Peptides Process Development

The goal of process development is to design a high-quality product manufacturing process that consistently produces a product of the expected quality level. CD Formulation can provide you with a wide range of process development services to seamlessly transition your therapeutic protein and peptide products to commercial manufacturing. We have extensive expertise in all aspects of upstream and downstream development of protein and peptide drug/product manufacturing processes to assist you with preclinical drug development and manufacturing.

What is Process Development for Protein and Peptide Biopharmaceuticals?

Process development for protein/peptide biopharmaceuticals is usually divided into upstream process (USP) development and downstream process (DP) development. The upstream process aims to produce the desired protein or peptide under cell culture conditions, including the selection of appropriate host cells, culture media and culture conditions. The downstream process aims to purify, structurally analyze, and study the stability of the upstream-produced protein or peptide to obtain high-purity and high-quality preparations.

In USP development, it is necessary to optimize cell culture conditions, including culture media composition, gas control, pH adjustment, etc., which helps to ensure high yield and high quality of the target product. In DP development, separation and purification steps need to be designed and optimized to eliminate impurities and obtain high purity of the target product. Commonly used downstream process steps include cell disruption, solid-liquid separation, chromatography, and gel electrophoresis.

Furthermore, process development for protein/peptide biopharmaceuticals is a complex process. The development of upstream and downstream processes must be combined with appropriate analytical methods. Only in this way can the defined product critical quality attributes (CQAs) be accurately determined during process development and optimization.

Fig. 1 Therapeutic protein/peptide process development stage. (CD Formulation)

Explore Our Therapeutic Proteins & Peptides Process Development Services

CD Formulation is an expert in process development for therapeutic proteins and peptides. Our process development capabilities include process development at any stage from upstream cell line development to downstream formulation process development, scale-up and transfer services, analytical testing services through process analytical technology (PAT), and product chemistry, manufacturing and control (CMC) regulatory approval.

With decades of process development experience and a deep understanding of different customer needs, we provide efficient and cost-effective process development packages, including cell culture process development, fermentation process development, peptide synthesis process development, downstream purification process development, formulation, and formulation process development.

Our services are customized. You can choose a single model or request a one-stop process development service from laboratory scale to commercial production.

How Do We Perform Process Development Services?

Our upstream and downstream process development for therapeutic proteins and peptides is based on the concept of Quality by Design (QbD). Using our scalable upstream cell development, culture, fermentation, and downstream purification technology platforms, we are able to develop processes with excellent quality and high yield successfully.

Our scientists use a laboratory-scale 3L bioreactor platform for robust process development, which can be scaled up to pilot and commercial 25L and 20000L to support the rapid filing of IND projects. We also provide a full range of process characterization services to support process validation.

Fig. 2 Implementation of QbD approach for the production of therapeutic drugs. (Gupta SK, et al.,)

Upstream and Downstream Process Development

• In this stage, we screen, select, and combine downstream processing technologies, using a systematic development path to achieve a process of required quality within an acceptable time.
• Identify quality attributes and criticality assessments.

Upstream and Downstream Process Optimization

• Use statistical tools to design and analyze data (DoE method) to establish optimal conditions for process variables.
• Improve productivity.

Process Characterization and Design Space Establishment

• Risk assessment to identify potentially critical process parameters (CPPs), statistical design of experiments (DoE), and studies to evaluate unit operation relevance.
• Categorize process parameters according to their criticality to define appropriate acceptable operating ranges.
• The obtained process and product information are used for design space approval and the definition of the impact of the manufacturing process on CQA variations, hence for the definition of testing and monitoring strategies.

Upstream and Downstream Process Scale-up

• The process platform developed at the laboratory scale will be scaled up to the pilot and commercial production scales.
• Proof of process reproducibility and consistency evaluation.

Analytical Method Development

• Establish process monitoring strategies to identify CQAs of protein and peptide products, including primary structure, higher order structure, post-translational modifications, heterogeneity analysis, antigen binding activity, cytotoxicity, etc.
• Demonstrate batch-to-batch consistency.

Why Choose Us for Therapeutic Proteins & Peptides Process Development?

• We have a team of experts in microbiology, fermentation engineering, formulation science, and protein chemists who can develop and optimize the entire upstream and downstream processes.
• We have a high-yield cell line development and continuous perfusion culture cell culture platform recognized and validated by global regulatory agencies, which can meet the culture process development of protein molecules with different properties.
• We have established a mature upstream and downstream process platform, combined with advanced in-process control analysis technology, to tailor the appropriate process for customers.
• We have multiple successful cases of technology transfer and scale-up to 20,000L commercial scale.
• Our process development laboratory is equipped with complete development equipment and testing platforms, including high-throughput Ambr micro-bioreactors and multi-specification small-scale bioreactors.
• We provide flexible experimental options to meet the needs of different customers.

Publication

CD Formulation understands the importance of developing a robust and reliable manufacturing process for your therapeutic proteins and peptides. Our goal is to assist you with process development and optimization, scale-up, technology transfer, and process validation to ensure that your product is manufactured efficiently and meets all regulatory requirements. 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.