LucasPye BIO
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Services
- Cell line & process development (opens in a new tab)
- Stable-clone development (opens in a new tab)
- Bioreactor process scale-up (opens in a new tab)
- Process characterization (opens in a new tab)
- Gene & viral vector manufacturing (opens in a new tab)
- Gene-based drug products (opens in a new tab)
- AAV programs (opens in a new tab)
- Upstream and downstream workflows (opens in a new tab)
- Analytical method development & QC (opens in a new tab)
- Method development and validation (opens in a new tab)
- Release testing and stability (opens in a new tab)
- Comparability testing (opens in a new tab)
- GxP bioanalytical testing (opens in a new tab)
- Regulatory & FDA support (opens in a new tab)
- FIH- and IND-enabling work (opens in a new tab)
- CTD-ready submission packages (opens in a new tab)
- FDA and EU regulatory expertise (opens in a new tab)
- Pre-IND interaction preparation (opens in a new tab)
- Integrated clinical execution (opens in a new tab)
- Clinical study strategy (opens in a new tab)
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Services
Capabilities
Quality & certifications
As a Contract Development Manufacturing Organization (CDMO), we help promote novel biologics, including biosimilars and biobetters, by offering our bio-manufacturing services below market price to Life Science Entrepreneurs, Small Biopharmaceutical Companies, and Non-Profit organizations that financially support new biologics discovered by the aforementioned entities. Source (opens in a new tab)