JenKem Technology provides custom PEGylated conjugates and PEGylation services for proteins, peptides, oligonucleotides, and small molecules; and custom PEG synthesis of PEG derivatives. PEGs have been shown to improve water solubility, biocompatibility, immunogenicity and PK/PD profile in drugs and other applications, and the ability to attach a variety of reactive functional groups to the terminal positions of these polymers has greatly increased their applications.
Custom Synthesis of PEG Derivatives
JenKem Technology offers custom PEG synthesis services via decades of expertise in synthesis of innovative PEG derivatives. JenKem Technology’s R&D department will develop and synthesize your desired PEG product to meet the unique needs of your project with the highest quality in the shortest possible time. For detailed information about our custom PEGylation and PEG synthesis services, please contact us at email@example.com. For information about catalog PEG products, please visit our PEG products page.
JenKem Technology’s dedicated and experienced technical support group can help you identify the right high quality PEG derivatives for your PEGylation needs. Currently JenKem Technology provides two service models to meet our customers’ unique needs:
PEGylation Service Model 1:
Custom synthesis of PEGylated conjugates: PEG-proteins, PEG-peptides, PEG-polypeptides, PEG-oligonucleotides, PEG-small molecules, PEG-ADCs, and more. PEGylated produts are provided as regular end-product. 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. 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
IND Approval Received for PEG-irinotecan Developed by JenKem Technology Co., Ltd., March 7, 2016. China FDA approved 3SBio Inc.’s Investigational New Drug (IND) appplication for PEG-irinotecan in early March 2016. 3SBio Inc., a leading biotechnology company in China entered into an exclusive license agreement with JenKem Technology Co., Ltd. in September 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
Founded in 2001 by recognized 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 on-site manufacturing from ethylene oxide, enabling facile traceability for GMP 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.