In addition to PEG derivative manufacture back integrated to polymerization from ethylene oxide, from R&D through commercial scale, JenKem Technology provides PEGylation services up to pre-clinical stage, and custom synthesis of PEGylated conjugates. PEGylation is a versatile tool to improve the water solubility, biocompatibility, immunogenicity, and the PK/PD profile of drugs. JenKem Technology’s dedicated and experienced PEGylation group offers two service models to meet your unique PEGylation needs for proteins, peptides, oligonucleotides, and small molecules.

Scheme of Protein PEGylation with JenKem® Y-PEG-NHS

Schematic of protein PEGylation with JenKem® patented Y-Shape PEG NHS

PEGylation Service Model 1

Custom synthesis of PEGylated conjugates, PEG-proteins, PEG-peptides, PEG-polypeptides, PEG-oligonucleotides, PEG-small molecules, and more, using JenKem® catalog PEGs or custom PEG products. JenKem Technology will PEGylate your own protein, peptide, oligonucleotide, or small molecule, and deliver your PEGylated product with a certificate of analysis as a regular end-product, for further testing at your site. This is recommended for an initial evaluation of PEGylation approaches.

PEGylation Service Model 2

Complete PEGylation method development service. Under this service model, JenKem will provide your PEGylated sample, as well as the complete method development package, including developed analytical methods for characterization of your PEGylated product, up to pre-clinical stage. JenKem Technology’s PEGylation group can help you identify the right high quality PEG derivatives for your project. The PEGylation processes developed by JenKem Technology are easily scalable and transferable and consist of the following main steps:

Phase 1: JenKem delivers PEGylated compounds to the customer for pharmaceutical analysis and provides a detailed report including PEGylation reaction conditions, separation and purification processes, and analytical methods for the PEGylated compounds.

  • PEG reagent screening
  • PEGylation reaction conditions screening
  • Separation and purification process development
  • Analytical method development (HPLC, SDS-PAGE, GPC, and other qualitative or quantitative methods for analysis of PEGylated products)
  • Synthesis, characterization and delivery of PEGylated molecule

Phase 2: JenKem coordinates the gathering of pre-clinical data by outside laboratories for PEGylated compounds and chooses the optimal PEGylated compounds according to this data.

  • Quality specification study of PEGylated molecules
  • Formulation study of PEGylated molecules
  • Pharmacodynamics study of PEGylated molecules
  • Toxicology study of PEGylated molecules
Example PEGylation Projects

IND Approval Received for PEG-irinotecan Developed by JenKem Technology Co., Ltd. – China FDA approved 3SBio Inc.’s Investigational New Drug (IND) appplication for PEG-irinotecan. 3SBio Inc., a leading biotechnology company in China entered into an exclusive license agreement with JenKem Technology Co., Ltd. in 2014 for the development, manufacturing and marketing in Mainland China of PEG-irinotecan. 3SBio Inc. intends to develop PEG-irinotecan for metastatic breast cancer and colorectal cancer, and platinum-resistant ovarian cancer and will undergo clinical trials in China. Read More

For detailed information about our custom PEGylation services, please contact us at tech@jenkemusa.com.

Founded in 2001 by experts in PEG synthesis and PEGylation, JenKem Technology specializes exclusively in the development and manufacturing of high quality polyethylene glycol (PEG) products and derivatives, and related custom synthesis and PEGylation services. JenKem Technology is ISO 9001 and ISO 13485 certified, and adheres to ICH Q7A guidelines for GMP manufacture. The production of JenKem® PEGs is back-integrated to in-house polymerization from ethylene oxide, enabling facile traceability for regulated customers. JenKem Technology caters to the PEGylation needs of the pharmaceutical, biotechnology, medical device and diagnostics, and emerging chemical specialty markets, from laboratory scale through large commercial scale.