FDF / DRUG PRODUCTS BIOLOGICS in Europe
Fill and finish site dedicated to GMP Formulation and the Aseptic filling of Sterile Liquid Injectables.
About the plant
White Raven is a flexible CDMO partner located at the heart of European biotech in Belgium. We specialize in GMP formulation and aseptic filling for small injectable batches. Our expertise enables biotech companies to focus on their products and clinical trials while we manage their process industrialization. With a fully digitalized, agile, and transparent approach, we are deeply committed to our clients, quickly adapting to project requirements while maintaining the highest quality standards.
We excel in aseptic filling and adaptive mixing solutions, serving vials, syringes, and cartridges through our state-of-the-art gloveless robotic isolator filling line. We handle a wide range of molecules (including BSL-2) and deliver batches of 100 to 20,000 units in just four months, ensuring high filling precision and minimal product loss (around 20–40 ml per batch).
Key Figures:
Batch range – 100 to 20,000 units.
BSL Level - BSL-2
OEB Level - OEB 5
Containers:
Vials - 2R - 100H
Syringes - 0.5ml - 20ml
Cartridges - 1.5ml - 20ml
Compliance
- EMA (EU GMP)
Activity
- Abs (Antibodies), ADC & NDC (Antibody-drug), Peptide, protein, hormone & enzyme, Oligonucleotides, Vaccines, LBP (Live Biotherapeutic Products), ATMP (Advanced Therapies), Injectables, Fill&Finish, Small volume vials, PFS (Prefilled Syringes), Cartridges, FDF / DRUG PRODUCTS, BIOLOGICS manufacturing
Features
- Uses: Investigational, Preclinical, Phase I, Phase II, Phase III, Human
- Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE = 1,000 - 5,000 µg/day), 3 (PDE = 100 - 1,000 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/day), 5 / HPAPI (PDE < 10 µg/day)
- Controlled substance: N/A
- BSL: 1, 2
- Therapeutic areas: N/A
- Markets: EMA (EU)
Batch Size / Reactor
- Small, Medium
Services
- Manufacturing services, Packaging, Fill&Finish, Sterile product manufacturing, Tech transfer, Formulation mixing, Research batches, Engineering batches, Scale-up, Pilot batches, Registration batches, Batch records, Primary packaging
