SunBio PEG Q&A
Q List
Q1. How good is the quality of SunBio PEGs ?
Q2. Can I obtain thorough analysis on the quality of SunBio PEGs ?
Q3. Can I use non-GMP-grade PEGs in preclinical animal studies ?
Q4. Can I use non-GMP-grade PEGs in clinical studies ?
Q5. What is GMP PEG, and can SunBio offer GMP PEGs ?
Q6. What is DMF, and can SunBio offer DMF ?
Q7. Can I obtain PEG derivatives that are not listed on PEG-SHOP catalog ?
Q8. Can SunBio offer SunBios own patented PEG technology ?
Q9. Can SunBio offer SunBios own patented PEG-drug technology ?
Q10. What are the strengths of SunBio PEGs and PEG technologies ?
Q1. How good is the quality of SunBio PEGs ?
The quality of SunBio PEGs is as good as any in the market. We also feature some PEG derivatives of which quality is unsurpassed. In general, the mPEGs we offer have less than 2% diol contamination, and have polydispersity of less than 1.05 ~ 1.1. With multi-branched PEG such as star PEG, the main peak fraction is greater than 85%. The functional activities of our PEG derivatives are over 95% in most cases.
Q2. Can I obtain thorough analysis on the quality of SunBio PEGs ?
We have two-tier system for quality analysis. One for small research orders, and the other for kilogram or GMP orders. For small research orders less than 1 kg, our certificate of analysis confirms on the molecular weight, diol contamination, polydispersity, functional group activity. For kilo or GMP orders, our certificate of analysis offers confirmation on water content, volatile organic compounds, impurities, endotoxin level, in addition to the above four parameters. For a review of our sample certificate of analysis, please go to our PEG-SHOP Catalog.
Q3. Can I use non-GMP-grade PEGs in preclinical animal studies ?
With our GMP-grade PEGs, you may certainly use them in preclinical trials. With our non-GMP-grade PEGs, you may want to consult your regulatory expertise before making the decision. However, you may find out that you do not need to use GMP-grade PEGs for your preclinical trials yet. Also, we have witnessed our customers using our non-GMP-grade PEGs in their preclinical trials without problem. With regulatory issues put aside, the quality of our non-GMP-grade PEGs is good enough to be used in preclinical trials as our PEGs are cleanly prepared so as to achieve undetectable level of endotoxin.
Q4. Can I use non-GMP-grade PEGs in clinical studies ?
It is our understanding that you are supposed to use GMP material in clinical trials. However, you may want to consult your regulatory expertise to clarify.
Q5. What are GMP PEGs, and can SunBio offer GMP PEGs ?
The GMP PEGs are PEGs and PEG derivatives manufactured at a GMP manufacturing facility under GMP guidelines. The operation systems and facilities are GMP certified and maintained in that they receive US FDA inspection and approval. SunBio offers GMP PEG derivatives that are manufactured in a GMP-certified plant. SunBio leases and operates a pilot plant from Yuhan Chemical Company of Ansan City, South Korea, where up to 100 kg of GMP PEG derivatives can be manufactured. SunBio/Yuhan GMP manufacturing plant has been in operation since 1998, and inspected by several US pharmaceutical companies.
Q6. What is DMF, and can SunBio offer DMF ?
The DMF stands for Drug Master File. A manufacturer of pharmaceutical ingredients may submit DMF application to the US FDA who then assigns a number to the DMF. The DMF is a thorough documentation on all aspects involved in the manufacture of the product. It includes documentation on the facility, personnel, process, validation, and quality control. It also includes production batch data collected from three separate lots, which is to demonstrate the reproducibility of the manufacturing process. SunBio and Yuhan are experienced in filing DMF for pharmaceuticals.
Q7. Can I obtain PEG derivatives that are not listed on PEG-SHOP catalog ?
We are happy to work with customers on custom synthesis of novel PEG derivatives.
Q8. Can SunBio offer SunBios own patented PEG technology ?
The PEG derivatives offered on our PEG-SHOP catalog are general knowledge, which means that the methods of synthesis are in public literature. However, we pride ourselves in making the best quality products available. Moreover, we are also very active in developing novel PEG derivatives that may be very useful in creating novel therapeutics. These new PEG technologies are also available for licensing.
Q9. Can SunBio offer SunBios own patented PEG-drug technology ?
We are also engaged in development of novel therapeutics such as PEG-hemoglobin and PEG-interferons. These are available for licensing or collaboration.
Q10. What are the strengths of SunBio PEGs and PEG technologies ?
Our strength is in offering our customers a one-stop service for PEG derivatives and biopolymers, GMP or non-GMP. We make our own raw material, we do the derivatization, and we offer GMP and DMF services, so customers who deal with us are satisfied with our logistics as well as with our quality. Our commitment to our customers satisfaction is also obvious in our willingness to work hard with customers towards customers goal.
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