Therapeutic Proteins & Peptides Upstream Fermentation Process Development

Fermentation is one of the key technologies for efficient, economical, and environmentally friendly industrial protein production. Our process development experts can create robust and reproducible upstream fermentation processes for you. We combine scientific knowledge with process development expertise to improve strain productivity for almost any project. Whether you are seeking microbial fermentation process development for small-scale, preclinical evaluation and proof-of-concept studies, or seeking a cGMP-compliant clinical or commercial-scale process, CD Formulation can provide you with customized solutions.

Introduction to the Fermentation Process

Fermentation technology is a biochemical process that uses microorganisms (such as bacteria, yeast, etc.) to metabolize organic matter. By controlling temperature, humidity, oxygen, pH and other conditions, the metabolic activities of microorganisms are used to produce enzymatic hydrolysis, oxidation-reduction, acidification and alkalization, etc., so that the organic matter in the raw materials undergoes various chemical changes to achieve the purposes of processing, degradation, extraction, fermentation, etc. In the production of protein drugs, microbial fermentation technology has been widely used in the large-scale production of high-quality protein drugs due to its short production cycle, low cost, and easy expansion. This process can insert the target gene into microbial cells through genetic engineering technology, and then use equipment such as fermentation tanks for cultivation and production. The specific steps include selecting suitable microbial strains, culturing strains, setting fermentation conditions (such as temperature, pH value, oxygen content, etc.) controlling these parameters, and finally separating, purifying, and purifying the fermentation products to obtain the target protein.

Explore Our Therapeutic Proteins & Peptides Upstream Fermentation Process Development

For protein and peptide biologics, robust and flexible upstream fermentation processes need to be implemented to efficiently transfer and scale up to accommodate various scales of production. CD Formulation has flexible facilities and state-of-the-art equipment, as well as extensive experience in optimizing microbial fermentation batch and fed-batch processes, allowing us to efficiently move your protein therapeutics from concept to industrial-scale production.

Our extensive microbial fermentation process development capabilities enable us to develop reproducible and scalable manufacturing processes to accelerate your project to the next stage quickly. Importantly, all of our approaches are tailored to the unique properties of your desired proteins and peptides.

Our fermentation process development services include:

• Apply quality by design (QbD) principles throughout the development process.
• Identification or design of fermentation strains that match industrial fermentation strains or fermentation strains relevant for vaccine production.
• Media development and optimization (media composition testing and optimization of media components: nitrogen source, carbon source, inorganic salts, trace elements).
• Culture condition screening and testing (temperature, pH, dissolved oxygen, time, inoculum size).
• Batch and fed-batch fermentation development.
• High-density fermentation using oxygen-enriched air.
• Optimization of feeding strategies at bench scale.
• Optimization of key fermenter parameters (temperature, pH, acid, base, feed, and induction solutions).
• Scale-up and technology transfer of fermentation processes.
• Small-scale identification and process characterization studies.
• Process scalability from bench scale to 150 L.
• Process characterization, process optimization, and process validation for late-stage clinical projects.

How Do We Develop Fermentation Processes?

Fig. 1 Flow chart of fermentation process development. (CD Formulation)

Our comprehensive research and development capabilities in microbial fermentation processes enable us to design and develop protein and peptide products that meet your needs - from pilot to small-scale testing to large-scale commercial production, with the highest level of quality control at each stage. We also follow regulatory systems to ensure that our products comply with all state and global regulations and guarantee product quality.

To fully realize the potential of developed strains, we consider the fermentation process development steps from the early stages of the project. The optimal media components are selected based on a detailed understanding of the strain's physiological parameters and using the existing resources of the production partner as much as possible. The scale-up starts with 5L and then increases to 25L to 150L fermenters. We ensure the step-by-step optimization of key bioprocess parameters and ultimately smoothly transfer the bioprocess to your desired production site.

Our Fermentation Capabilities

Fermentation Condition Screening and Fermentation Medium Optimization

• Dissolved oxygen (DO) concentration and DO supply conditions.
• Fermentation technical parameters (pH, temperature, stirring speed, etc.).
• Fermentation medium optimization.

Scale-up and Pilot Production

We provide professional scale-up production process design, and equipment design technical services, and can provide pilot production services.

• Experience in handling thousands of microbial strains.
• We are proficient in fermentation production processes such as fermentation, separation, and drying.

State-of-the-art Fermentation Equipment

Our fermentation capabilities are developed to include methanol feed, oxygen enrichment, continuous centrifugation, and high-pressure homogenization, ensuring the highest quality and efficiency throughout the manufacturing process. Our cGMP-compliant systems utilize stainless steel fermenters of various sizes. Whether you require small-scale production or large-scale manufacturing, our facilities are tailored to provide the best results for your protein/peptide product.

• Fermenters from 50 to 10,000L.
• High-pressure homogenizer.
• Aseptic lyophilizer.
• Fermentation Equipment.

Why Choose Us for Upstream Fermentation Process Development?

• We have researchers in the fields of fermentation engineering and microbiology who can develop and optimize the entire fermentation process.
• Our fermentation process development department is equipped with a range of advanced equipment, including large-scale fermenters, pilot fermenters, experimental fermenters, and sterile-grade freeze dryers.
• Our team of fermentation process experts has developed commercial-scale processes for hundreds of protein and peptide products.
• Our fermentation process development services are based on low-cost, fully synthetic culture media, avoiding the use of expensive additives to shorten the production time of your products.
• We are able to scale up strains from the laboratory to commercialization and scale up fermentation processes to 10,000L.
• We provide flexible experimental options to meet the needs of different customers.

Publication

CD Formulation's process developers have extensive experience in optimizing microbial fermentation batch and fed-batch processes for the production of different types of protein and peptide biologics. We utilize scalable, benchtop, single-use stirred bioreactor systems to perform the statistical DOE and process optimization studies to develop high-quality, optimal yield protein and peptide products that meet your needs. 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.