Peptide GMP Manufacturing

BOC Sciences has more than 20 years of experience in the synthesis and cGMP production of peptides and peptide-related compounds. We specialize in production using liquid phase, solid phase and hybrid synthesis techniques. As one of the largest peptide contract manufacturers in the world, we have 4 production bases and nearly 1,000 employees. The advanced technical team of BOC Sciences has accumulated rich professional knowledge in the field of peptides, and can develop more than 1,000 kinds of peptide compounds by combining SPPS, LPPS, structural chemistry and fragment polycondensation methods, with a success rate of over 98%. Our peptide production bases are equipped with advanced peptide synthesis, separation and purification and testing equipment to ensure a stable commercial production process and are an ideal business partner for your cGMP peptide needs.

What are Peptides?

Peptides are two or more amino acids connected by a peptide chain, between large molecule proteins and small molecule amino acids, and are functional nutrients essential for the body to accomplish various complex physiological activities. Peptides, as basic materials, constitute active substances in the body such as enzymes, hormones, antibodies, interneurons, etc., and regulate the physiological functions of various systems and cells, which are irreplaceable and important for cellular activity, functional activities, and the existence of life. Peptide drugs mainly include peptide vaccines, anti-tumor peptides, anti-viral peptides, peptide-directed drugs, cytokine-mimicking peptides, antimicrobial active peptides, diagnostic peptides, as well as other small peptides for medicinal purposes. Because of their wide indications, high safety, and remarkable efficacy, peptide drugs can be widely used in the prevention, diagnosis, and treatment of tumors, cardiovascular and cerebrovascular diseases, hepatitis, diabetes, AIDS, and other diseases. Peptides can be categorized according to molecular weight size:

  • Small peptides - Small peptides, also called small molecule peptides, are highly active peptides consisting of only 2 to 4 amino acids.
  • Oligopeptides - Oligopeptides are peptides consisting of 2-10 amino acids, with molecular weights generally below 1000 daltons.
  • Polypeptides - Polypeptides refer to peptides consisting of 10-50 amino acids.
  • Proteins - Proteins generally refer to peptides consisting of more than 51 amino acids.

Peptide Synthesis

With the rapid development of peptide therapeutics, peptide synthesis technology must take into account both economic benefits and sustainability. Whether it is solid phase synthesis (SPPS) or liquid phase synthesis (LPPS), the goal is to minimize the impurity content to reduce tedious purification steps, improve synthesis efficiency, and thus reduce the economic and environmental burden. Based on this, BOC Sciences has launched customized peptide synthesis, synthesis process development, drug peptide modification and peptide API R&D services. We can design a reasonable transformation strategy for the target peptide according to customer requirements. We offer a variety of options in scale, purity level, modification and salt form. Our goal is to quickly provide high-quality peptide products for your drug discovery research, with a wide range of synthesis scales from mg to kg. Our products can be provided in the form of resin, coarse powder and purified powder, with the required purity up to 99%. A variety of peptide products, including linear peptides, cyclic peptides, modified peptides and peptide-based complex conjugates can be obtained.

Solid Phase Peptide Synthesis

One of the main methods used in peptide synthesis is solid phase peptide synthesis (SPPS). SPPS is a widely adopted technique in which peptide chains are assembled on a solid support material, usually a resin. In the solid phase synthesis method, the C-terminus of the first amino acid is pre-fixed on an insoluble carrier resin, and the deprotected N-terminus of the amino acid is connected to the second amino acid with activated carboxyl group through a condensation reaction, and the operation is repeated to achieve the desired peptide chain length. Then the peptide is cleaved, modified, separated and purified to finally obtain the target peptide. BOC Sciences' solid phase peptide synthesis service involves the use of state-of-the-art equipment and expertise to produce high-purity and high-yield peptides, mainly including the Boc method and the Fmoc method. The advantages of solid phase peptide synthesis include:

  • High purity: SPPS is able to produce high-purity peptides, minimizing impurities that may affect the biological activity of the peptides and research results.
  • Customization: BOC Sciences provides customized peptide synthesis services, allowing researchers to create peptides with specific sequences, modifications and tags for their unique applications.
  • Scalability: Solid phase peptide synthesis is a scalable process suitable for producing different quantities of peptides, from milligrams to kilograms, to meet various research and commercial needs.
  • Time efficiency: SPPS is a fast peptide synthesis method that can be completed quickly when producing custom peptides for research projects or product development.

Liquid Phase Peptide Synthesis

In addition to solid phase peptide synthesis, BOC Sciences can also provide liquid phase peptide synthesis services. Liquid phase peptide synthesis involves the sequential coupling of amino acids in solution without the need for solid supports. Liquid phase synthesis can be subdivided into stepwise synthesis and segmented synthesis. Stepwise synthesis usually starts from the C-terminus of the peptide and adds amino acids one by one until the target peptide is synthesized. This method is generally suitable for the synthesis of short peptides or various bioactive peptide fragments. The core idea of segmented synthesis is to rationally divide the target peptide into several fragments, and after synthesizing these fragments, they are connected and condensed to finally obtain the target peptide. Although liquid phase peptide synthesis is less frequently used than SPPS, it also has its own advantages.

  • Flexibility: Liquid phase peptide synthesis can synthesize complex peptides that may be difficult to produce using SPPS, providing flexibility in peptide design and synthesis strategies.
  • Easy purification: Liquid phase synthesized peptides are easier to purify due to the absence of a solid support matrix, thereby improving the purity of the final product.
  • Compatibility with certain modifications: Liquid-phase peptide synthesis may be more suitable for incorporating certain modifications or chemical functionalities into the peptide that may be hindered by the solid support in SPPS.

GMP Peptide Manufacturing

BOC Sciences' GMP peptide manufacturing services are designed to meet the stringent requirements of Good Manufacturing Practice (GMP) regulations, ensuring the production of high-quality, reliable peptides for drug development, clinical trials, and commercialization. In addition to custom synthesis of peptides, we utilize a range of purification techniques such as HPLC, preparative chromatography, and ion exchange chromatography to achieve high purity levels for our peptides. Throughout the manufacturing process, we follow strict quality control protocols to monitor and assess critical quality attributes such as purity, potency, stability, and endotoxin levels. In addition, prior to delivery, all of our peptides undergo rigorous characterization and analysis to confirm their identity, purity, and structural integrity. Whether simple linear or complex cyclic peptides, our team of experienced chemists are able to manufacture peptides of various lengths, sequences, and modifications with high purity and yield.

Facilities & Equipment

  • 40,000 square feet of cGMP manufacturing space
  • 100+ fermentation reactors up to 120 m3 commercial scale
  • Up to 10000 L enamel reactors for LPPS
  • Up to 1000 L stainless steel reactors for SPPS
  • 2 Preparative purification labs with freeze dryer
  • Quality assurance: GC-MS, LC-MS, NMR, IR
  • Microwave process equipment
  • Multi-channel automation technology

CDMO Capabilities

  • Sequence lengths of 2-100 amino acids
  • Synthetic peptides as crude products
  • Synthetic peptides as HPLC purified materials
  • Milligram to kilogram cGMP production batches
  • Stability determination and residual solvents testing
  • Process development, scale-up and validation
  • Commercial manufacturing
  • Technical support and regulatory compliance

Quality System

Our peptide production is strictly in accordance with FDA's cGMP guidelines, and an independent quality department has been set up to conduct a comprehensive review of the production process. We have established good cooperative relations with raw material suppliers, and can complete contract manufacturing at low cost on the premise of ensuring quality, saving your project expenses. In addition, our production lines meet current production quality management specifications and are operated by professional staff.

  • Product testing
  • Solubility testing
  • Purity testing
  • Molecular weight testing
  • Impurity identification
  • Microbial limit testing
  • Analysis verification and stability testing
  • Process transfer method validation
  • Central control and environmental control testing
  • FDA audited manufacturing sites
  • Auditing electronic batch records for cGMP status
  • Corrective & preventive action tracking (CAPA)
  • Document management and document control
  • Analytical testing and release of the product
  • Client confidentiality
  • Ensuring safety, integrity, strength, purity, and quality (SISPQ)

Client Confidentiality

We are well aware of the importance of intellectual property rights and are committed to strictly guarding our clients' business secrets. The company has set up a security and confidentiality system to ensure the security of information in the process of cooperation. Everything is guided by your satisfaction. If you are interested in our peptide cGMP manufacturing service, please contact us immediately. In addition, custom development services for peptides can also be quickly obtained at BOC Sciences.

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