---
name: Sophia CDMO
slug: sophiacdmo
site: cdmo
website_domain: sophiacdmo.com
summary: European CDMO specializing in microbial and precision fermentation up to 40,000 L across two integrated sites (Pamplona, Spain and Basel, Switzerland), with core strengths in E. coli expression, animal health biologics, probiotics, and complex CMC programs requiring scale-up discipline and impurity control. Headquartered in Pamplona, Spain.
tagline: European microbial CDMO with integrated process, analytics, and GMP manufacturing up to 40,000 L.
founded_year: 
employee_count_band: 
employee_count_label: 
parent_name: 
parent_slug: 
hq_country: ES
tier2_domain_verified: false
updated_at: 2026-07-30T04:27:26.361Z
services_count: 18
modalities_count: 5
indications_count: 0
locations_count: 2
review_signal_gate: closed
generated_by: BioBM Editorial AI
---

# Sophia CDMO

European microbial CDMO with integrated process, analytics, and GMP manufacturing up to 40,000 L.

Listed on cdmo.directory.

## Summary

European CDMO specializing in microbial and precision fermentation up to 40,000 L across two integrated sites (Pamplona, Spain and Basel, Switzerland), with core strengths in E. coli expression, animal health biologics, probiotics, and complex CMC programs requiring scale-up discipline and impurity control. Headquartered in Pamplona, Spain.

## At a glance

- HQ country: ES

## Services

- Process Development
- Upstream Processing
- Downstream Processing
- CMC Analytical Development
- Stability Testing & Storage
- CMC Regulatory Submission Support
- Technology Transfer
- Microbial Fermentation
- Recombinant Protein Manufacturing
- Sterile Fill-Finish & Aseptic Manufacturing
- Lyophilization (Freeze Drying)
- Extractables & Leachables Studies
- Quality Control Testing
- Cell-Line Development
- mRNA Manufacturing
- Lipid Nanoparticle (LNP) Formulation
- Oligonucleotide Manufacturing
- Peptide Manufacturing

## Modalities

- Biologics (Other)
- mRNA
- Oligonucleotide
- Peptide
- Microbiome Therapeutic

## Locations

- Headquarters, Pamplona, Navarre, Spain
- Headquarters, Basel, Basel-Stadt, Switzerland

## Long description

## Overview

Sophia CDMO is a European contract development and manufacturing organization built around integrated process development, analytical development, GMP manufacturing, and quality systems for biologics and fermentation-enabled products. The company operates as a single platform across two headquarters:

- **Pamplona, Spain**: Microbial and precision fermentation scale-up to 20,000 L
- **Basel, Switzerland**: Large-scale biomanufacturing capacity up to 40,000 L

## Core Capabilities

**Fermentation & Upstream Processing**
- Microbial upstream optimization and scale-up planning
- E. coli recombinant protein expression
- Fungal protein expression (Pichia)
- Strict anaerobe fermentation
- Yeast strain engineering and cell banking

**Downstream Processing & Manufacturing**
- Downstream development with impurity and endotoxin-aware strategies
- Hold-time, robustness, and process consistency planning
- Sterile fill-finish services
- Blow-fill-seal manufacturing
- Lyophilized injectable manufacturing

**Analytical & Development Services**
- Analytical method development
- Characterization and stability strategies
- Extractables and leachables testing
- Biosimilar analytics
- Process development aligned to CMC decision-making

**Specialized Modalities & Markets**
- Animal health biologics
- Probiotics and postbiotics
- Live biotherapeutic products
- mRNA LNP formulation
- Exosomes (microbial and plant-derived)
- Circular RNA
- siRNA
- Cosmetic bioactives and skincare formulations
- Drug-device combinations

## Operating Model

Sophia's differentiation centers on integrated execution: process development, analytics, manufacturing, and quality systems operate as one program rather than fragmented vendor handoffs. The company emphasizes early control strategy definition, analytics-driven process decisions, right-first-time documentation, governance discipline, and continuous improvement embedded in manufacturing operations.

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_Profile last updated: 2026-07-30T04:27:26.361Z. Profile facts may include AI-assisted enrichment._

Auto-generated by BioBM Editorial AI for machine-readable profile access.