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Large Scale Therapeutic Peptide Synthesis

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Large-scale peptide synthesis is more than just increasing the amount of raw materials used, it requires developing protocols from scratch to ensure cost-effective production while maintaining high quality. With decades of experience and innovative large-scale peptide synthesis platforms, CD Formulation is committed to providing a smooth and professional large-scale peptide synthesis service from protocol design to product delivery.

About Large Scale Therapeutic Peptide Synthesis

Synthesis of large-scale peptides is accomplished using either solid-phase or liquid-phase synthesis.

  • Solid-phase synthesis has the advantage of shorter process development and manufacturing times and greater cost efficiency in small- to medium-scale production, but is also competitive in large-scale processes and for the production of peptides with longer sequences and more complex side chains.
  • However, as product volumes increase, liquid-phase peptide synthesis may have advantages. The key is to optimize process development to achieve efficient conversions at each amino acid coupling to produce high-purity crude synthetic custom peptides and minimize the requirements for downstream processing.

Fig. 1 Peptides production in industrial scale.Fig. 1 Main methods (recombinant cell-based system and chemical synthesis) utilized for peptide production on an industrial scale. (Mulder KC, et al., 2013)

Explore Our Large Scale Therapeutic Peptide Synthesis Services

At CD Formulation, our expansive service in large-scale peptide synthesis mirrors the excellence of our bespoke peptide synthesis offerings, such as high purity and high synthesis success rate for very long peptides (<200 AA).

Our seasoned scientists, armed with unparalleled expertise, stand ready to unfurl the potential of your peptides, including very hydrophobic peptides, peptides with multiple disulfide bonds, multi-phosphorylated peptides, and very long peptides.

In addition, we also provide preliminary cost analysis, project review, research and development, process optimization, and detailed quality control reports to ensure that your peptides can be successfully and efficiently delivered.

Our large-scale peptide synthesis service includes:

  • Selection of synthesis route.
  • Optimization of reaction conditions.
  • Purification and post-processing of products.

Key Features of Our Large-Scale Peptide Production

Highly Controlled Production Process

Harnessing cutting-edge production technologies alongside a rigorously enforced quality management framework, we meticulously orchestrate every phase of the manufacturing journey to unfold under the most favorable of conditions. This intricate ballet of processes elevates not just the uniformity and pristine nature of the final product but also adeptly caters to the unique requisites of a diverse clientele.

Dedicated Staff and Facilities

Our facilities boast avant-garde equipment and cutting-edge technology, meticulously designed to accommodate an extensive array of requirements—ranging from experimental small-batch trials that hum with potential to colossal industrial-scale productions that resonate with efficiency and precision.

Flexible Customized Solutions

We proudly offer a dynamic array of bespoke services tailored intricately to the unique demands of our clients. Whether it's the elaborate design of peptide structures, the meticulous crafting of synthesis protocols, or the sophisticated intricacies of purification processes, we embrace every facet of customization. Every project is an opportunity to foster innovation and precision, adapting our expertise to the ever-evolving landscape of customer needs.

Our Purification Methods for Large Scale Synthesis Peptide

Although most peptide synthesis methods are highly efficient, many of these processes can still generate unwanted impurities due to incomplete deprotection, unwanted reactions between free-protecting groups, truncation and/or deletion of amino acids, isomers, and other byproducts.

Our scientists can repeatedly remove these impurities by using one or more of the following cleanup techniques:

Among them, RP-HPLC / RP-UPLC is the most widely used purification method. This technique captures hydrophobic molecules from an aqueous solution and releases them based on their hydrophobicity. This makes it easier to separate correctly synthesized peptides from unwanted impurities.

Peptide Manufacturing & Analytical Services

In addition to peptide synthesis capabilities, we combine flexible GMP manufacturing facilities with cutting-edge peptide analytical knowledge to provide a full range of quality control testing services to accelerate the commercialization of your products, including:

  • Peptide identification (ESI-MS).
  • Peptide Molecular weight determination.
  • Peptide sequencing.
  • Peptide quantification/peptide content determination.
  • Peptide purity and impurity analysis (HPLC/UV).
  • Amino acid sequence.
  • Amino acid composition determination.
  • Net peptide content.
  • Enantiomeric purity testing (GC/MS; LC).
  • Residual counterion testing (e.g. TFA).
  • Elemental analysis.
  • Residual solvent testing.
  • Water content testing (GC or KF).
  • Peptide solubility testing.
  • Peptide stability testing.
  • Optical rotation determination.
  • Bioburden testing(TAMC/TYMC).
  • Bacterial endotoxin testing.
  • Sterility testing.
  • Cytotoxicity testing.
  • Process/product related impurity testing.
  • Other pharmacopoeia testing.

Delivery Specifications

Our expertise in synthetic peptide manufacturing enables us to produce high-quality, large-scale, and GMP-compliant peptides. All peptides undergo stringent quality control.

Properties Specifications Quality Control (QC)
Form Freeze-Dried Powder
Quantity ≤2 kg
Purity ≥98% HPLC
Length <200AA
Peptide Content ≥85% Elemental Analysis
Water Content ≤5% Karl Fischer Titration
Acetate Content ≤15% RP-HPLC / RP-UPLC
Amino Acid Analysis Meets Expectations ±10% RP-HPLC / RP-UPLC
Certificate of Analysis Supplied With The Product

Publication

Published Data

Technology: Large Scale Solid Phase Synthesis of Peptide Drugs

Journal: Int J Pept.

IF: 2.0

Published: 2012

Results:

The authors present a simple method for simultaneous quenching and removal of iodine and separation of disulfide-bridged peptides. The removal of oxidized peptides from aqueous acetic acid/methanol solutions using excess inexpensive anion exchange resins quantitatively removes iodine and other colored impurities, and the method is applied to commercial, large-scale synthesis of various peptides, including desmopressin, oxytocin, and octreotide. The results show that this new method has significant advantages, such as simpler practicality, minimal side reactions, large-scale synthesis of peptide drugs, and greater cost-effectiveness.

Fig. 2 Desmopressin synthesis.Fig. 2 Scheme for solid phase synthesis of Desmopressin. (Reddy KM, et al., 2012)

CD Formulation has extensive experience in large scale therapeutic peptide synthesis. Each synthesis step is subject to our strict quality control. Please don't hesitate to contact us if you are interested in our services. We look forward to cooperating with you.

References

  1. Andersson L, Blomberg L, Flegel M, et al. Large-scale synthesis of peptides. Biopolymers. 2000;55(3):227-50.
  2. Mulder KC, Viana AA, Xavier M, et al. Critical aspects to be considered prior to large-scale production of peptides. Curr Protein Pept Sci. 2013 Nov;14(7):556-67.
  3. Bray BL. Large-scale manufacture of peptide therapeutics by chemical synthesis. Nat Rev Drug Discov. 2003 Jul;2(7):587-93.
  4. Reddy KM, Kumari YB, Mallikharjunasarma D, et al. Large Scale Solid Phase Synthesis of Peptide Drugs: Use of Commercial Anion Exchange Resin as Quenching Agent for Removal of Iodine during Disulphide Bond Formation. Int J Pept. 2012;2012:323907.
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