Services

Cell Line Development (CHO/HEK)

Stable pools and monoclonal lines engineered for high productivity and product quality. Monoclonality and stability confirmed, with a documented lineage and Research Cell Bank.

  • Vector engineering and transposase‑enabled integration
  • High‑throughput clone screening with productivity and quality readouts
  • Stability/consistency studies across generations
  • Research Cell Bank and tech transfer data package
CLD workflow

Upstream Process Development

Scale‑down models (1–3 L) and multi‑reactor studies to optimize media, feed, and parameters using DoE. We define CPPs that govern CQAs such as glycan patterns, charge variants, and aggregation.

  • Media/feed optimization and temperature/seed/feeding strategies
  • DoE for parameter space and robust ranges
  • Scale‑up studies to 10–50 L single‑use reactors
  • Run robustness and reproducibility checks
Upstream PD diagram

Downstream Purification Development

Capture and polishing trains tailored to modality, with UF/DF and formulation to produce a stable, high‑purity drug substance.

  • Harvest clarification and primary capture (e.g., Protein A)
  • Polishing: IEX, HIC, mixed‑mode as needed
  • UF/DF, viral steps (as applicable), and formulation screens
  • Yield tracking and impurity clearance (HCP/DNA/aggregates)
Downstream PD diagram

Analytical & Bioassay

Identity, purity, structure, potency, and safety assays designed early so methods are ready to validate at GMP sites.

  • MS, SE‑HPLC, IEX/HIC, glycan/charge profiling
  • ELISA, Octet/SPR, cell‑based potency, internalization
  • Endotoxin, bioburden, HCP ELISA, residual DNA
  • Method transfer packages and SOPs
Analytics diagram

Scale‑Up & Non‑GMP Manufacturing

Engineering runs and tox/PK material supply at pilot scale to de‑risk GMP. Full documentation and data for a clean tech transfer.

  • 1–3 L development, 10–50 L engineering runs
  • Non‑GMP batches for tox/PK/formulation
  • Batch records, recipes, and performance summaries
  • On‑site/remote SME support during transfer
Scale-up diagram

Regulatory Documentation Support

CMC‑ready documentation aligned to IND expectations: cell line history, development reports, analytical method SOPs, and process descriptions.