From Genetic Blueprint to Qualified Drug Product
Elise Biopharma’s Process Development & Manufacturing division converts molecular designs into robust, compliant, and economically viable processes. Spanning cell-line creation through aseptic fill-finish—and reinforced by rigorous process characterization—our integrated platform de-risks scale-up, compresses timelines, and delivers clinical or commercial material that meets every critical quality attribute.
Cell Line Development
A high-performing, genetically stable cell line is the foundation of any successful biologic.
- Vector & Host Engineering Codon-optimized genes, promoter/terminator libraries, and site-specific integration (CRISPR, Flp-In, RMCE) for CHO, HEK293, Pichia, and E. coli.
- Clone Selection & Stability High-throughput screening (Octet, Ambr 15, Micro-bioreactors) followed by 60-generation genomic stability and productivity tracking.
- Banking & QA Master and Working Cell Banks manufactured in ISO 5 suites, mycoplasma-free, with adventitious agent and genetic identity certification ready for IND.
Upstream Process Development & Scale-Up
We translate shake-flask expression into cGMP bioreactors with predictable performance.
- DoE-Driven Optimization Statistical models define ideal pH, temperature shifts, feeds, and gas-transfer rates.
- Single-Use & Stainless Platforms 2 L to 2 000 L capacity in batch, fed-batch, or perfusion modes; PAT dashboards track OUR/CTR, Raman titer, and metabolite flux in real time.
- Digital Twins Machine-learning models predict kLa, viscosity, and heat load—cutting traditional scale-up cycles by 25–40 %.
Downstream Purification & Recovery
Purity, yield, and viral safety are engineered, not left to chance.
- Capture & Polish Toolbox Protein A/G/L, IEX, HIC, mixed-mode, SEC, and TFF/UF-DF—configured via resin scout matrices and aggregate analytics (SEC-MALS, DLS).
- Continuous Chromatography Multi-column PCC and SMB options for high-volume mAbs and Fc fusions.
- Viral Clearance Integration Low-pH inactivation, 20–75 nm nanofiltration, and detergent treatments designed in parallel with purification DoE for regulatory-ready clearance studies.
Formulation & Fill-Finish
A stable, patient-ready drug product completes the journey.
- Formulation Science Buffer/ excipient scouting, high-concentration protein development (>150 mg mL⁻¹), LNP screening for mRNA, and lyophilization cycle design.
- Aseptic Operations Grade A isolators with robotic fill in vials, pre-filled syringes, or cartridges; 100 % in-line weight check and container-closure integrity testing.
- ICH Stability Real-time, accelerated, photostability, and freeze-thaw studies with CCI, potency, and particulate trending.
Process Characterization & Validation
Understanding the design space ensures reproducibility and smooth regulatory review.
- CPP/CQA Mapping Link critical process parameters to product attributes using multivariate analytics.
- Scale-Down Models 2 L and 10 cm columns replicate full-scale performance for robustness and viral-clearance studies.
- PPQ & Continued Process Verification Three-batch validation, cleaning validation, and Stage 3 CPV dashboards meet FDA/EMA expectations.
Contract Manufacturing—Clinical to Commercial
With processes locked, manufacturing slots can be reserved in the same facility—eliminating tech-transfer risk.
- Clinical Supply GMP runs from Phase I micro-lots to Phase III multi-kilogram campaigns, supported by QP release and global logistics.
- Commercial Launch >90 % facility right-first-time metrics, redundant utilities, and forward-capacity planning for lifecycle demand.
- Lifecycle Optimization Post-approval change management, yield-improvement DoEs, and cost-of-goods reduction delivered under a single quality system.
Why Partner with Elise?
- One-Site Continuity Cell line ➝ Process ➝ GMP DS ➝ DP without cross-vendor hand-offs.
- Digital Transparency Client portal shows live batch data, deviations, and quality documentation.
- Regulatory Foresight Hundreds of IND/IMPD modules and multiple BLA contributions ensure smooth agency interactions.
Let’s turn your concept into a validated, market-ready product. Contact Elise Biopharma’s Process Development & Manufacturing team to map out a tailored, risk-balanced path to clinic and beyond.