J-STAR’s South Plainfield facility is registered with the DEA as a research facility for schedules II-V. Our chemists are trained and equipped to meet the specialized shipping & receiving, record-keeping and secure-storage processes required to maintain full compliance through all activities, from Synthesis, Analysis and Crystallization to cGMP.
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Recent trends in drug development have seen a surge in demand for Potent & HPAPI Compound Development capabilities, a demand J-STAR is perfectly positioned to meet. Our state-of-the-art facility can help meet the needs of your high potency development programs as our subject matter experts ensure that we will handle your API programs with the highest level of care and safety to ensure success.
Learn MoreDeveloped analytical methods to follow the conjugation reaction, reaction purity, and ADC purity after purification using a NAP-10 column. After several rounds of conjugations, it was determined that ADC can be formed with very high reproducibility in DAR value for a given reaction condition, and DAR was found to be very linear with the linker-antibody ratio. The purity of payload was the key determinant of DAR with lower purity in payload resulting in lower DAR.
Identified parameters that impacted the purity of the payload and consequently allowed us to set purity specifications to ensure the successful preparation of ADCs. Additional work was performed to evaluate the modification of the NAP-10 purification protocol by collecting smaller fractions, and this was found to improve the purity of the ADC, although the recovery is lower.
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