Therapeutic Peptides Downstream Purification & Isolation Process Development

Downstream process development of synthetic peptides is a crucial step in their clinical application. Through sophisticated process optimization and analytical identification, the quality and activity of synthetic peptides can be guaranteed, laying a solid foundation for their clinical application. With years of experience in providing satisfactory downstream process development solutions to each customer, CD Formulation provides downstream separation and purification services for crude peptide mixtures obtained based on all preparation methods to design and manufacture high-quality purification processes.

Importance of Process Development for Peptide Purification & Isolation

It is well known that almost all crude peptide mixtures are complex and require purification, whether they are prepared stepwise using solid phase peptide synthesis and solution phase synthesis, or isolated from natural sources. Even if chemical synthesis reactions are strictly controlled, impurities are inevitably formed, which may include missing, truncated or chemically modified sequences, including cleavage adducts or other by-products formed during processing. Downstream separation and purification of crude peptides helps to:

• Improve product purity: As a biologically active molecule, the purity of peptides plays a vital role in their activity and stability. Through appropriate separation and purification processes, impurities and other impurity components can be effectively removed to improve the purity of the product.
• Ensure product quality and activity: Through appropriate separation and purification processes, the quality and activity of peptide products can be ensured, and problems such as degradation and inactivation caused by impurities and insufficient purity can be avoided.
• Reduce production costs: Through the development of optimized separation and purification processes, production efficiency can be improved, and production costs can be reduced.

Fig. 1 Purpose of peptide purification and isolation process development. (CD Formulation)

Explore Our Therapeutic Peptides Downstream Purification & Isolation Process Development

The isolation purification process development of synthetic peptides requires extensive expertise and a theoretical foundation to address a variety of unique challenges. At CD Formulation, our team of process experts has decades of experience in executing successful projects for downstream process development of therapeutic peptides, providing a wide range of peptide isolation and purification process development services to customers around the world.

Our services include:

• Evaluation of biophysical and biochemical properties of peptides to guide downstream process development and optimization.
• Integration of process development and analytical method development to optimize downstream purification steps.
• Purification of synthetic peptides by solid phase extraction (SPE).
• Purification of synthetic peptides by preparative liquid chromatography.
• Peptide purification at different scales using various chromatographic techniques.
• Small-scale process characterization and scale-down validation studies.
• Process scale-up and rapid technology transfer and expansion to cGMP production scale.
• Process characterization, process optimization, and process validation for late-stage clinical projects.

How Do We Purify and Isolate Peptides?

Fig. 2 Typical flow scheme of a peptide purification and separation process. (CD Formulation)

Crude Peptide Purification

• Throughout the crude peptide purification process, capture concentration technology is a key tool we use.
• For crude peptide fermentation broths from biosynthesis, which contain many impurities such as byproducts, residual reactants, and salts, capture concentration technology can be used to separate the target molecule from most impurities.
• In this crude separation technology, we use polymer adsorption resins to remove the target peptide and related molecules. This leaves behind impurities, which are then removed from the product. Changing the solvent releases the peptide, resulting in a higher-purity peptide product stream.

Separation of Various Scales Peptides

• The main challenge in peptide separation and purification is the structural homology between the main peptide and its impurities, including impurities with the same amino acid composition, impurities with fewer amino acids (missing sequences), diastereoisomers (due to racemization), beta peptides produced by isomerization of aspartic acid and serine, and modified peptides produced by alkylation of methionine, tryptophan, and tyrosine.
• In the purification and isolation of the final peptide product, we look for the best purification method based on the peptide sequence, charge, solubility, and physicochemical properties, including anti-solvent HPLC, lyophilization, crystallization, and precipitation. We have the ability to separate purified peptides of various scales.
• The final purified product needs to be obtained in powder form. We use lyophilization, precipitation, crystallization, and spray drying to handle

How Do We Develop Purification & Isolation Processes for Therapeutic Peptides?

• During downstream process development, we comprehensively evaluate the risks that may arise during process development and identify key impurities (negatively affecting yield, purity, and yield) and the subsequent iterative process of synthesis and purification development. Through structured and systematic experimental work, the number of variables is reduced.
• On this basis, the design and control space of the process is defined to identify and control key process parameters and operating ranges.
• Design process validation procedures and perform stability studies/storage conditions of solutions during purification to ensure the feasibility and stability of the process.

Our Technology Platform

Why Choose Us for Therapeutic Peptides Downstream Purification & Isolation Process Development?

• Our team of experienced scientists and researchers have expertise in peptide purification and isolation techniques, ensuring the highest quality results.
• We offer customized solutions tailored to your specific needs and requirements, ensuring optimal purification and isolation processes for your therapeutic peptides.
• Our state-of-the-art facilities are equipped with cutting-edge technology and equipment, allowing us to efficiently and effectively purify and isolate therapeutic peptides.
• We maintain strict quality control measures throughout the purification and isolation process, ensuring the purity and integrity of your therapeutic peptides.
• We provide flexible experimental options to meet the needs of different customers.

Publication

CD Formulation utilizes state-of-the-art equipment and cutting-edge techniques to develop efficient and cost-effective purification processes for synthetic peptides. Whether you are in need of downstream process development for a specific synthetic peptide or looking to scale up production for clinical trials, our team has the expertise and capabilities to support your project. 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.