GMP Service
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GMP Service

BOC Sciences is a high-tech enterprise specializing in the scientific research, development and production of chemicals and biochemicals according to the requirements of cGMP. The sub-brand AAPEP is committed to providing cGMP manufacturing services of high-quality amino acids, peptides, resins and PNA monomers. Our product and process development team can quickly develop suitable processes, saving customers a lot of time and development costs.

What is Amino Acid?

Amino acids are organic compounds that are building blocks of proteins, which are vital to the structure and function of living cells. In drug development, amino acids play a crucial role in the creation of peptide-based drugs. Peptide drugs are made up of short chains of amino acids that mimic the effects of naturally occurring proteins in the body. These drugs offer several advantages over traditional small molecule drugs, including greater specificity and potency, as well as lower toxicity and side effects. Therefore, peptide drugs have become an important area of focus for drug development. In addition to their role in drug development, amino acids are also used in the manufacture of other pharmaceutical products and cosmetics, such as cell culture media, diagnostic reagents, cosmetic development, nutritional supplement raw materials, etc.

Amino acids and peptides

What is Peptide?

Peptides are short chains of amino acids linked together by peptide bonds. The sequence of amino acids in a peptide determines its structure and function. Peptides range in size from a few amino acids to dozens of amino acids. Peptides with fewer than 50 amino acids are often called oligopeptides, while peptides with more than 50 amino acids are often called proteins. In addition to classifying peptides according to size and structure, peptides can also be classified according to function, such as signal peptides, antimicrobial peptides, hormone peptides, etc. Peptides have a wide range of functions in the body, including protein synthesis and cell signaling. Peptides are also used in a variety of medical research and therapeutic agents. Peptide drugs are small peptides designed to target specific molecules in the body and treat disease. For example, peptide hormones such as insulin and growth hormone are used to treat diabetes and growth disorders, respectively. Peptide drugs are also being developed to treat a variety of other diseases, including cancer, autoimmune diseases, and infectious diseases.

Amino Acid cGMP Manufacturing

BOC Sciences is a leading provider of cGMP manufacturing services for amino acids, offering a broad range of amino acids used in drug development and manufacturing. Our state-of-the-art facilities and expertise in amino acid synthesis enable us to produce high-quality amino acids in large quantities to meet the needs of pharmaceutical companies and research institutions. In addition to amino acid synthesis, BOC Sciences offers a range of other services related to drug development, including custom peptide cGMP manufacturing, PNA monomer cGMP manufacturing and bioconjugation services.

cGMP Capabilities

AAPEP has an excellent R&D and production team. The company strictly abides by cGMP management standards, always pays attention to product quality, strictly implements industry standards, and supplies global products, especially amino acid series products are complete. In order to meet the growing market demand, the company continues to develop cutting-edge amino acid products with high-tech content to meet the new needs of global customers, and can provide various amino acid products according to customer requirements, ranging from milligrams to kilograms. Our cGMP grade product production is carried out in a highly controlled environment using qualified equipment and personnel. Our GMP division factory facilities are dedicated to cGMP services and have undergone various validations to meet cGMP requirements.

Technical Support

BOC Sciences has an experienced team of scientists and experts to provide technical support for amino acid and peptide production. We are familiar with the latest technologies and methodologies in the field and can provide guidance on process optimization, troubleshooting and product customization to meet specific requirements. Whether customers want to develop new peptide sequences, optimize existing processes, or troubleshoot manufacturing issues, BOC Sciences' technical support team is ready to provide expert guidance and assistance.

  • SPPS, LPPS, structural chemistry and fragment polycondensation methods
  • Various amino acid protection methods and types of peptide modifications
  • Proven synthesis, purification and isolation technologies
  • Batch production of mg to kg products
  • Can synthesize peptides up to 200aa
  • Stable commercial production process

Production Capacities

BOC Sciences has state-of-the-art amino acid and peptide manufacturing facilities with production capabilities to meet both small-scale and large-scale needs. We have the capability to produce a wide range of amino acids and peptides, including custom synthesis and modification of complex peptides. Our production technologies include solid-phase peptide synthesis, liquid-phase peptide synthesis and recombinant protein expression, allowing the synthesis of peptides of a variety of lengths and complexities. The company's expert team is able to work closely with customers to develop customized synthesis solutions and processes to ensure that the final product meets the customer's specific requirements.

  • 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
  • FDA audited manufacturing sites

Analytical Capabilities

BOC Sciences has comprehensive analytical capabilities to ensure the quality and purity of amino acids and peptides. Our commitment to analyzing and characterizing products using advanced analytical techniques such as HPLC, LC-MS, NMR and mass spectrometry ensures that the final product meets the required specifications and standards.

  • Development, optimization, qualification, and validation of test method
  • Compound characterization: GC-MS, LC-MS, NMR, IR etc.
  • Lot release testing: HPLC, MS etc.
  • Stability study
  • Troubleshooting

Quality Control and Quality Assurance

Quality control and quality assurance play a vital role in the quality of product production, ensuring that the product achieves its intended purpose. Our quality department can be divided into two parts. One is quality assurance and the other is quality control. We have standard operating procedures in compliance with quality policies, certified cleanroom areas, customizable product solutions, good manufacturing practices, and comprehensive batch records. We offer a variety of optional quality control testing methods to ensure that the final cGMP grade product meets the requirements. Our production process, testing process and document control process fully comply with cGMP standards and meet strict FDA requirements. Our cGMP specifications and testing procedures include:

  • Appearance
  • Solubility
  • Purity (HPLC, UPLC)
  • Molecular weight (MS)
  • Amino acid analysis
  • Amino acid content
  • Peptide content
  • Ion content
  • Moisture (Karl Fisher)
  • Residual solvent content (GC-MS)
  • Trifluoroacetic acid residue
  • Microbial limit
  • endotoxin
  • Elemental analysis (ICP-MS)

BOC Sciences is widely acclaimed for its high-quality products and excellent service. The company has perfect equipment, advanced instruments and strict confidentiality system to ensure that the production process is strictly controlled and the product quality meets customer requirements. All products are produced and inspected in strict accordance with international standards. Taking "customer satisfaction" as the high management goal, we always welcome and listen carefully to the suggestions of all parties, and make improvements and improvements in a timely manner.

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