Biologics CDMO
CHO/HEK platforms. DoE-driven process development. IND-ready documentation. Non‑GMP scale-up with clear tech transfer.
CHO/HEK stable lines with multi‑g/L productivity. Monoclonality and stability confirmed.
Design‑of‑Experiments (DoE) for upstream/downstream with defined CPP/CQA ranges.
Identity, purity, glycan/charge, potency, safety — methods ready for transfer.
Engineering runs and tox supply to de‑risk GMP; complete CMC documentation.