Therapeutic Proteins & Peptides Production Process Scale-up

The purpose of process scale-up studies is to verify, review, and improve the reaction conditions determined by laboratory process studies so that the same or similar results can be obtained by applying them to larger-scale industrial production. As an expert in process development for therapeutic proteins and peptides, CD Formulation provides you with single or integrated process scale-up services, covering the upstream cell culture and fermentation process, upstream peptide synthesis process, downstream purification process, and formulation process.

What is Process Scale-up?

Process scale-up studies generally include pilot scale-ups and industrial/commercial scale-ups that comply with GMP. When the laboratory process of biopharmaceutical process research is completed, i.e., the drug process route is confirmed by demonstration, it is generally necessary to undergo a pilot scale-up that is 50 to 100 times larger than the small test scale. On the basis of pilot scale-up, the process is used to conduct process research under conditions that simulate industrial production to verify the feasibility of the original process after scale-up production and ensure the consistency of the process during research development and production.

In the entire process of process scale-up research, pilot scale-up plays an unparalleled role as an intermediate bridge between laboratory scale and industrial scale. Pilot-scale scale-up studies can verify the feasibility and stability of laboratory-scale research results on a larger scale, providing supporting data for industrial workshop design, construction and installation, intermediate quality control, and the formulation of quality requirements and procedures.

Fig. 1 Process scale-up flow. (CD Formulation)

Explore Our Therapeutic Proteins & Peptides Production Process Scale-up Services

Whether it is novel drug development or generic drug development, small-scale studies are required in the laboratory to determine the quality target product profile (QTPP), clarify the potential critical quality attributes (CQAs) of the product, select the appropriate production process and the critical process parameter (CPP), and determine the control strategy of factors affecting the product CQAs. For formulation development studies, it is also necessary to determine the critical quality attributes (CMA) of raw materials, excipients, etc., and clarify the formulation composition and formulation ratio.

CD Formulation has the ability to handle any challenges of any type of protein and peptide products in the small-scale research stage and transfer the small-scale process to the pilot plant and commercial production plant that comply with GMP. Our biopharmaceutical process development team has rich experience in process scale-up and transfer, providing customers with one-stop therapeutic protein and peptide process transfer services, covering upstream and downstream process development and optimization, upstream and downstream process verification and confirmation, upstream and downstream process scale-up and transfer, and formulation process scale-up.

In process scale-up studies, we will determine the optimal reaction conditions and parameters, including temperature, pH value, pressure, ion concentration, stirring speed, etc., through systematic experimental design and data analysis. We will also take into account the various challenges and limitations that may be encountered in industrial production to ensure that the scale-up production process is stable and reliable and can meet quality standards and requirements.

Our process scale-up services include:

Fig. 2 Key steps involved in the process scale-up of therapeutic proteins and peptides. (CD Formulation)

Upstream Cell Line Culture and Fermentation Process Scale-up

We have a professional and mature upstream process scale-up and transfer platform, providing customers scale-up services with commercial scales from laboratory scale, pilot scale, and clinical scale to up to 20,000L. Our scientists scale up production based on the principles of P/V value, oxygen mass transfer rate (Kla), mixing time, and tip line speed to ensure that the process performance and quality attributes are comparable during process transfer and scale-up.

• In the pilot scale-up stage, we are able to scale up to 20-40 mL by using Cytiva disposable bioreactors.
• In the commercial stage, our scale-up scale is 10,000L to 20,000L in stainless steel bioreactors.

Peptide Synthesis Process Scale-up

We have mature peptide synthesis methods, using solid-phase synthesis and liquid-phase synthesis to provide customers with high-quality peptides. In solid-phase synthesis, we can scale up and produce up to 300 kg of GMP peptide active pharmaceutical ingredients (APIs). In solid and liquid-phase synthesis processes, we can scale up to 50 kg of peptide APIs.

Downstream Purification Process Scale-up

Our downstream purification process scale-up involves chromatography scale-up and membrane package/filter scale-up.

• For chromatography scale-up, we follow the principle of constant column height and linear flow rate, and linear scale-up of column diameter and volume flow rate.
• For membrane package scale-up, we follow the principle of constant flow rate per square meter of membrane area and linear scale-up of membrane area and volume flow rate.

Formulation Process Scale-up

We have a GMP production workshop equipped with complete formulation process development equipment and related testing instruments, which can realize the process amplification of various dosage forms such as macromolecular pre-filled injections, lyophilized powder injections, eye drops, oral solutions, inhalation preparations, etc. Our research team has a strong professional level and rich experience in formulation process amplification, and establishing corresponding process control indicators to achieve industrial production.

General Content of Process Scale-up Studies

• Verification of upstream and downstream processes and formulation processes.
• Optimization of reaction conditions and key parameters.
• Selection of equipment materials and types.
• Determination of process flow and operation methods.
• Quality monitoring of raw materials, auxiliary materials, and intermediates.
• Development of final process quality control strategy.

Our Technology Platforms

Why Choose Us for Therapeutic Proteins & Peptides Production Process Scale-up?

• Our team of scientists and researchers have extensive experience in the production and scale-up of therapeutic proteins and peptides.
• We have successfully completed numerous projects for a variety of clients, demonstrating our expertise in the field.
• We have cutting-edge facilities equipped with the latest technologies and equipment to ensure efficient and high-quality production of therapeutic proteins and peptides. Our facilities are designed to meet the specific requirements of each project, ensuring optimal results.
• We work closely with our clients to tailor our services to their specific needs. Whether you require small-scale production for research purposes or large-scale production for commercial purposes, we can customize our services to meet your requirements.
• Our streamlined production process and efficient project management practices help us deliver projects on time and within budget.
• We prioritize communication and transparency throughout the production process, ensuring that our clients are kept informed every step of the way.

Publication

CD Formulation provides customized upstream and downstream scale-up services for therapeutic proteins and peptides to help you establish scale-up and stability strategies for your manufacturing process, and successfully transition to cGMP-grade production. 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.