Analytical and Regulatory

Method creation, verification, structure elucidation and impurity work, for drug substance and drug product, across small molecules, peptides and oligonucleotides — including high potency compounds at an occupational exposure limit of 10 ng/m³. 

For peptides, the hard measurement is epimerization. We quantify D-isomer content by acid hydrolysis and derivatization followed by LC-MS, covering all nineteen isomeric natural amino acids plus ornithine — asparagine and aspartic acid, and glutamine and glutamic acid, are reported together. Identity is confirmed by tandem LC-MS/MS and by peptide mapping after enzymatic digestion. 

For oligonucleotides, the hard measurement is a sequence one base short. Our HPLC purity method for sgRNA has moved from separating n−8 and n+4 impurities to separating n−2 and n+1. Where impurities co-elute with full-length product in HPLC-UV, mass spectrometric purity is used instead for qualification and quantitation — routinely for tRNA, sgRNA, PMO, PPMO and ASO. 

Instrumentation includes two-dimensional UPLC coupled with Q-TOF high-resolution MS, HPLC-CAD, MALDI-TOF, LC-Orbitrap and LC-QQQ; solid-state characterization by XRPD, DVS, DSC and TGA; 400 and 600 MHz NMR; circular dichroism and thermal melting; and elemental analysis by ICP-OES and ICP-MS.

Method qualification and validation for IND, NDA and commercial use, with GMP method transfer performed to USP <1224>. Full release testing across raw materials, reagents, intermediates, drug substance and drug product. 

More than 39,000 drug substance batches and 3,800 drug product batches are released across the platform every twelve months, and more than thirty Pre-Approval Inspections have been waived by the US FDA and EMA since 2023.

Our regulatory teams prepare IND, IMPD and NDA submissions for the US FDA, EMA and China’s NMPA, and have submitted more than 1,000 CMC submission packages supporting global IND and NDA filings since 2019. 

A US IND submission package typically takes six to eight weeks to prepare. That is possible because dossier preparation writers are part of the project team, filing templates go out at project initiation, and sections are written as data arrives. 

Scope covers regulatory consultation on phase- and modality-appropriate strategy by country, section writing across phases, and data review with the sponsor as it is generated, so questions surface before the filing is assembled.