Manufacturing

Need manufactured ELISA kits or reagents such as proteins and DNA or RNA?  No job too small...Give us a call! 

Marin Biologic can help you even if you need only a small amount.  We are not too big nor too busy to meet your need, no matter the size. 

ELISA Kits for Clinical Studies Manufacture

Phase 1 and phase 2 clinical studies often start out small...maybe 20 or 30 patients. One recent client needed assay kits manufactured, both to be used at Marin Biologic and to be sent to clinical sites. Kits may be used for entering patients into trials or monitoring biomarkers.  We have developed and validated assays and designed custom kits that have been used in multi-site trial clinical laboratories. We have manufactured from 10 to over 2,000 kits under GLP compliance with a Technical Manual, Standard Curve and Quality Control Samples. We stored the kits under GLP guidelines until they were couriered to the clinical sites upon request. Our scientists trained the technicians and qualified the clinical laboratories to run the assay with accuracy and precision.  

Proteins – Antibodies Manufacture

Marin Biologic scientists have scaled up cell culture and purification to manufacture small production lots of expressed proteins, up to several grams per week, some of which have been antibodies. Our strategy is to optimize the cell cultures as we scale up, in order to reach the maximum cell density with the least cost in media and maximal production rate per cell of the expressed protein. Some clients request the cell “paste”/pellet for their further studies. For other clients our scientist have produced stable mammalian cell transfectants and subsequently used the clones to produce protein in quantities of up to hundreds of grams. For other clients we have transformed bacterial cells and expressed protein with subsequent refolding and purification using a variety of techniques. We produce a purification table, a picture of a SDS-PAGE gel or non-denaturing gel, and sometimes a Western blot which will suggest the optimal methods of purification.

DNA – RNA Manufacture

When you need large amounts of DNA or RNA, our scientists can manufacture these molecules. We have routinely manufactured RNA for cDNA synthesis as well as RNA for a variety of uses (e.g. biomarker expression in array format). Our large cell culture methods allow the cells to be in impeccable condition, whereby the RNA extracted is of the highest quality. Some of our clients have requested us to manufacture large quantities of DNA and perform restriction digests for DNA marker resale. Our high standards for quality in production have allowed clients to use our DNA for a variety of applications and end uses.