Biologics: Development & Drug Substance Manufacturing

Integrated services support biologic drug substances across the full development lifecycle, from cell bank generation through commercial manufacturing. Capabilities span upstream and downstream process development, analytical method development, extended product characterization, and viral clearance studies, all designed to manage increasing molecular and process complexity.

Process scale‑up laboratories feature both single‑use and stainless‑steel technologies, enabling smooth transitions from early development into larger‑scale production. Clinical and commercial manufacturing operations offer broad capacity ranges and dedicated purification suites, supported by teams experienced in process characterization, validation, and regulatory readiness. Multiple manufacturing sites and built‑in contingency planning help ensure continuity of supply as programs progress.

Expertise covers a wide range of biologic modalities, including monoclonal antibodies, fusion proteins, bi‑specific constructs, and antibody‑drug conjugates. Together, these integrated capabilities help mitigate development risk, streamline scale‑up, and support reliable biologics manufacturing from early programs through global commercial launch.