Five minutes at CPhI worldwide with …
Lihong Guo – VP Operations for JenKem Technology USA
CT/PH: What is JenKem specialty?
Lihong Guo: JenKem Technology is one of the leading companies providing high quality PEG raw materials and PEG derivatives from very low molecular weights to as high as 80000 Da. JenKem Technology currently supplies PEG derivatives for preclinical, clinical trial, and commercial use in the pharmaceutical, biotechnology, and medical device marketplaces worldwide. Specific strengths are in development and manufacture of Y-Shaped PEGs, Methoxy PEGs, Homobifunctional PEGs, Heterobifunctional PEGs, Multi-arm PEGs, Multi-arm Heterobifunctional PEGs, Monodisperse (Discrete) PEGs, Biodegradable PEG Co-Polymers (such as PEG-PLGA, PEG-PLA, PEG-PCL, and other block polymers), and PEG GPC Standards, with custom synthesis services provided in all these areas. Additionally, JenKem offers PEGylation services for proteins, peptides, oligonucleotides and small molecules, and conjugation of PEGs to other polymer systems, from R&D through commercial scale. JenKem Technology is back-integrated to the preparation of a broad range of PEG products via the in-house polymerization of ethylene oxide. In-house control of the polymerization allows high quality, reproducible products from low to high molecular weight, typically having low polydispersity and high purity. JenKem Technology is a private Chinese company that has been in business globally for over 15 years, with headquarters and administration in Beijing, China. Its primary R&D, production, scale-up, and GMP manufacturing is now based out of a new plant in Tianjin, China that came on-steam in early 2014. Our GMP production facility in Tianjin, China allows JenKem to do large scale manufacture of PEG derivatives. A new plant that opened in the summer of 2017 prepares all ethylene oxide polymerizations to “raw” PEGs and is located in Panjin, China. The new Panjin plant also has the capability of the purification of these raw PEGs under GMP conditions if needed for even higher quality products. JenKem Technology USA, the international sales office of JenKem Technology, handles the sales of JenKem® PEGs and PEGylation services to all customers located outside mainland China.
CT/PH: What functionalization do you offer?
LG: JenKem Technology offers a wide range of functionalization, for example, PEG NHS products capable of reacting with protein lysines yielding an amide-linked conjugate; aldehyde-functionalized PEGs that link to the N-terminus of peptides and proteins; and thiol-reactive PEGs for cysteine-specific PEGylation. The range of products is wider, with JenKem manufacturing over 350 activated PEGs, with maleimide, hydrazide, amine, acrylate, cleavable linkers, click chemistry groups, lipids, oligopeptides, and many other functionalities. Beyond the catalogue-listed items, a large part of our business is custom synthesis of PEG products that meet customers’ specific needs.
CT/PH: Also as monodisperse PEGs?
LG: JenKem Technology offers many high purity monodisperse PEGs in our catalogue. We can offer more by custom synthesis, in research scale or larger scale manufacture, depending on customers’ requirements.
CT/PH: And what about GMP compliance?
LG: JenKem Technology has a quality system and manufacturing plant designed to meet the GMP needs of our customers. ISO 9001, ISO 13485, and ISO 14001 certifications are maintained, ICHQ7A guidelines are followed, and the IP of others is respected.
CT/PH: What do you see for the future of PEG technology and market?
LG: Traditionally the main use for PEGs was PEGylation, to improve solubility, increase the half-life, and lower the immunogenicity of biological drugs such as proteins.Recently new applications have been developed for PEGs, for example: hydrogels, ADC and other crosslinkers, controlled release drug delivery, diagnostics, surface modifications, and 3D printing. JenKem continues to work with the customers and follow the latest trends to ensure that JenKem is well positioned to respond to developing PEG needs to provide new PEG products. For example, we have presented novel PEG ADC-linker related research at the 2017 Controlled Release Society Annual Meeting in Boston in the Soapbox Presentation session, and plans are in place to present more results next year.
