Analytic Services Express provides laboratory testing services for compounding pharmacies, including sterility, potency, and lot testing, with a two‑day turnaround. It also offers RNA analysis and antibody/biologic characterization for pharmaceutical and biotech developers. Clients submit samples online, ship them to the lab, and receive certificates of analysis through a secure portal, paying per test or via service contracts.
Funding
Funding not disclosed
Founders
Product
Problem
Compounding pharmacies must demonstrate sterility, potency, and endotoxin compliance for each batch, but conventional testing can take weeks, delaying product release and increasing the risk of regulatory non‑conformance. Biotech programs developing therapeutic antibodies or RNA‑based modalities also need fast, high‑quality analytical and development services to stay on schedule.
Solution
Analytic Services Express operates a US‑based laboratory that delivers USP‑compliant sterility, potency, and endotoxin results within two business days, eliminating the typical multi‑week bottleneck. Samples are shipped to the facility, processed using validated qPCR, ATP‑bioluminescence, and LAL assays, and results are uploaded to a secure, audit‑ready portal where clients can download certificates of analysis instantly. In parallel, the company offers an integrated RNA platform—covering UTR screening, codon optimization, in‑vitro transcription, high‑performance liquid chromatography purification, and functional validation—including advanced formats such as circular RNA, self‑amplifying RNA, and guide RNA. For antibody and biologic development, ASE provides end‑to‑end services from cloning and high‑density expression in Expi293/ExpiCHO cells to binding‑kinetics measurement (BLI/SPR) and comprehensive developability profiling (SEC, DSF, DLS, HIC), supported by phage‑display library screening and next‑generation sequencing. The combined offering accelerates regulatory release for pharmacies and shortens development timelines for biotech programs while maintaining rigorous data integrity.
Target Audience
Primary customers are sterile compounding pharmacies that require rapid, USP‑compliant release testing, and biotech companies developing therapeutic antibodies, mRNA vaccines, or other RNA‑based therapeutics that need accelerated analytical and development services.
Features
- qPCR‑based sterility assay delivering results in 48 hours (USP <1223> compliant)
- ATP‑bioluminescence rapid sterility platform (Celsis) with 5‑day turnaround
- USP <85> endotoxin testing using LAL methodology, sensitivity down to 0.01 EU/mL
- Potency quantification via HPLC, USP <797> validated for multi‑API formulations, 2‑day TAT
- Secure, role‑based web portal for real‑time tracking, certificate download, and audit logs
- RNA services employing proprietary codon‑optimization algorithms, custom cap structures (Cap 0/Cap 1), modified nucleotides, and HPLC/fragment‑analysis QC pipelines
- Advanced RNA modalities support: circular RNA, self‑amplifying RNA, and CRISPR guide RNA production
- Antibody pipeline featuring Expi293/ExpiCHO expression scaling from 96‑well to shake‑flask, BLI/SPR kinetic analysis, and developability assays (SEC, DSF, DLS, HIC)
- High‑throughput phage‑display library construction, automated biopanning, and NGS hit identification
- Functional validation suite including ELISA, Western blot, flow cytometry, and reporter‑gene assays