Optimisation of the upstream process and harvesting procedure for aerobic and facultative anaerobes

Drug product formulation development: liquids and solid drug products (i.e. after solidification via spray drying or freeze drying)

Development of colon-targeted  oral drug delivery products

Analytical development (compendial or modified compendial testing)

Dedicated, technical experts involved from early development to clinical manufacturing to ensure a seamless transition from development to GMP

Segregated, grade C suites up to biosafety level BSL-2
GMP cell banking services (Master cell bank, Working cell bank)
Single-use fermenter solution up to 40L working volume
Closed and single-use production systems to maintain culture purity
DP fill and finish for oral/nasal applications
DP labeling activities
Manufacturing of matching placebo
Temperature controlled storage of bulk drug substance and (bulk) drug product
Clinical trial supply
QP release and full documentation:

QA reviewed batch record documents
Certificate of conformity/Batch certificate
TSE/BSE certificate
Certificate of analysis 

Quality control testing for M/WCB, in-process testing, QC release & stability testing and characterization:

Incoming QC of raw materials
Assay qualification
Stability testing

With significant analytical capabilities, we offer the expertise and techniques required for a full characterisation of your live biotherapeutic products.

Due to their unique nature, LBPs are subject to regulatory scrutiny. Eurofins CDMO has experience with many LBP projects and works with regulatory specialists in this field to support applications for clinical trials.