Process Characterization Services at Elise Biopharma
De‑risking scale‑up, defending your design space, and accelerating BLA success.
A Broader Perspective—Why Process Characterization Matters Now
The sprint from first‑in‑human dosing to commercial launch grows shorter every year, yet regulatory expectations for process knowledge have never been higher. 21 CFR 211, ICH Q8‑Q11, and the FDA’s Emerging Technology Guidance all point to a single imperative: prove that your manufacturing process can deliver a safe, potent, and pure product—batch after batch, site after site.
That proof doesn’t materialize overnight. It demands a structured, Quality‑by‑Design (QbD) program that identifies critical quality attributes (CQAs), pinpoints critical process parameters (CPPs), and couples them with real‑time analytics and hard data. At Elise Biopharma, we weave those threads into one continuous narrative: from our high‑throughput scale‑down models and multivariate statistical engines to our pilot and commercial suites equipped with electronic batch records and advanced PAT. The goal is simple yet transformative—turn development data into an audit‑ready story that speeds your biologic, vaccine, or nanoparticle therapy to market while insulating it from future change‑control headaches.
| Service Module | Core Activities | Typical Deliverables |
|---|---|---|
| Strategy & Risk Mapping | – QbD road‑map creation – FMEA workshops – CQA/CPP ranking & traceability | Risk register, CQA‑CPP matrix, draft control strategy |
| Design‑of‑Experiment (DOE) Suites | – Screening & fractional DOE – Response‑surface & definitive‑screen DOE – MVDA & ANOVA modelling | Proven design space, set‑point guidance, statistical reports |
| Scale‑Down Model Qualification | – Parallel 1 L upstream reactors – 50–250 mL downstream SDMs – Static & dynamic similarity testing | Qualified SDM protocols, comparability dossiers |
| Upstream Characterization | – Media/feed/perfusion matrices – pH, DO, agitation studies – In‑line Raman & off‑gas MS profiling | CPP limits, predictive control algorithms, PAT dashboards |
| Downstream Unit‑Operation Studies | – Depth‑filter & kSep® robustness – Capture/polish resin screens – Viral inactivation & UF‑DF shear maps | Viral‑clearance plan, resin lifetime model, yield‑vs‑purity maps |
| Formulation & Fill‑Finish | – Excipient & stress DOEs – Lyophilization cycle design – Media‑fill simulations | Acceptable ranges, bracketing/hold‑time justifications |
| Statistical & Lifecycle Support | – Pp/Ppk & control‑chart set‑up – CPV dashboards – Annual Product Reviews | PPQ protocol, CPV plan, change‑control toolkit |
| Specialty Modalities | – RNA‑LNP microfluidic DOEs – Viral‑vector perfusion models – Nanoparticle CQA assays | Nanomedicine QTPP, scale‑up risk map, IND/IMPD sections |
| Tech‑Transfer & Validation | – Engineering runs at 200–2 000 L – PPQ lot strategy – eBR/MBR authoring & audit defense | PPQ report, validation master plan, tech‑transfer binder |
Why It Matters
- Regulatory Fast‑Track – FDA‑endorsed QbD and DOE frameworks slash review cycles and cut down on post‑submission queries.
- Robust Design Space – Justified operating ranges minimize deviations and simplify multi‑site tech transfers.
- Cost Control – Early parameter optimization boosts yield and purity, driving COGS lower before commercial scale‑out.
Elise Biopharma Advantages
- High‑Throughput SDM Lab – 24 parallel 1 L bioreactors plus 12 downstream mimics compress months of experimentation into weeks.
- Data‑First Culture – Digital twins, MVDA, and PAT keep decisions evidence‑based, not intuition‑based.
- Integrated Expertise – Upstream, downstream, analytical, validation, and RA/QA teams operate under one roof for friction‑free execution.
Your Path Forward—From “Promising” to “Proven”
Process characterization isn’t a regulatory checkbox; it’s a strategic lever that can shave millions off your launch budget and months off your approval timeline. By partnering with Elise Biopharma, you gain a team that lives and breathes QbD, a lab arsenal built for speed, and a track record of INDs, BLAs, and global launches defended without a single major observation.
Ready to lock down your process and propel your therapy toward commercial reality?
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