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 GMP. The sub-brand AAPEP is dedicated to the research and development of amino acids, peptides, resins and peptide nucleic acid (PNA) monomers.

GMP Process Development

AAPEP's product and process development team can quickly develop suitable processes, saving customers a lot of time and development costs.

GMP Production

AAPEP has an excellent R&D and production team. The company strictly abides by GMP 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. AAPEP's GMP grade product production is carried out in a highly controlled environment using qualified equipment and personnel. AAPEP's GMP division factory facilities are dedicated to GMP services and have undergone various validations to meet GMP requirements.

Technical Support

AAPEP has accumulated rich expertise in the fields of amino acids, peptides, PNA monomers, and resins.

  • 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

AAPEP's production facility is scaled up to better meet customers' GMP needs.

  • 100+ Fermentation Reactors up to 120 m3 commercial scale
  • Up to 10000L Enamel reactors for LPPS
  • Up to 1000L Stainless steel reactors for SPPS
  • 2 Preparative purification labs with freeze dryer
  • FDA audited Manufacturing sites

Analytical Capabilities

  • 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

Analytical Capability

Quality Control and Quality Assurance of GMP

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 GMP 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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