Eurofins BioPharma Product Testing provides manual aseptic processing services for various drug product configurations with flexibility to accommodate a wide range of compounds, primary packaging systems, batch sizes and fill volumes.
Our sterile fill & finish activities are performed in Class A BioSafety Cabinets in Class B clean rooms and cover a large array of product types, including:
- Small molecules
- Biologicals such as antibodies, proteins, enzymes, and vaccines
- Peptides, RNAs, and DNAs
An isolator is used for highly-potent compounds such as hormones and cytostatics (no penicillins and cephalosporins).
Available primary packaging and fill volumes
|Primary Packaging Systems||Volumes|
|2R DIN vials to 1 liter bottles||
|Nasal spray devices|
Drug Substance Compounding
We perform fill & finish activities with ready-to-fill bulk solution, and we can also perform the compounding of the bulk solution.
Compounding is performed in Class C clean rooms that are equipped with Class A BioSafety Cabinets.
Our compounding facilities, equipment, and procedures guarantee the highest standards in manufacturing of your product and our compounding process will be executed according to your specified procedures.
Our expertise includes manual small scale GMP manufacturing of liquid, cytotoxic, biological and sterile products, including:
- Clinical trial material (all phases)
- Small scale commercial batches
All manufacturing processes use fully disposable contact parts, thereby avoiding the need for cleaning. Disposable contact parts include:
- Polymer bag mixing systems
- Sterile filters and tubing assemblies
- Peristaltic pump tubing
- Fill needle
Eurofins BioPharma Product Testing supports customers’ drug product manufacturing with a highly experienced and capable staff plus a 1,400 ft2 (110 m2) manufacturing suite that includes an ISO 8 clean room. We specialize in GMP manufacturing of a wide range of non-sterile clinical products, including:
- Topical products (creams, lotions, ointments, gels)
- Solutions (oral, topical, nasal)
- “Atypical” active pharmaceutical ingredients
- Dry blends
- Reagents, and diagnostic kit components
- Specialty products