Bio Elpida Pharmaceutical Support Services
Formulation, Aseptic Fill & Finish… we provide additional services to your cell based product
Further to its core services, Bio Elpida also provides additional services to support your cell based product:
- Formulation of wet and dry formats such as sterile liquid, lyophilisation, spray drying…
- Aseptic Fill & Finish for vials and pre-filled syringes
- Regulation IMPD
- Drug Analytical Development
- Bulk Purification
FormulationIn line with your cell therapy product, Bio Elpida proposes to help you with the adequate parenteral formulation either dry (freeze-dried) or liquid (sterile suspension or solution). Based on our experience and alliances with expert organisations, we provide access to the following processes:
- Sterile liquid formulation and processes,
- Spray-drying, including sterile processing.
Fill and finishAt Bio Elpida, we can provide small-scale semi-automatic Aseptic Fill and Finish services for vials and prefilled syringes (up to 6,000 units/day). We use XYZ filling machine with peristaltic pump for the filling step and a semi-automatic stoppering machine for the vial or syringe closer.
Of course, we are fully compliant with cGMP regulation and are able to perform such service for the production of clinical batches.
Regulatory IMPDCell based advanced therapies represent a relatively new field of development in the pharmaceutical industry and as you might be aware, the culture of cells used in Advanced Therapies is subjected to strict regulations and standards.
Regulation EC/1394/2007, published on 13th December 2007, includes Somatic Cell Therapy, Gene Therapy and Tissue Engineering under the term "Advanced Therapies" and defines the used products as "Advanced Therapy Medicinal Products" (ATMP). The requirements for risk management have been tightened. Furthermore full traceability for all starting and raw materials must be warranted.
Hence, thanks to its experience, Bio Elpida proposes to help you with your regulatory matters.
TrainingAdditionally to the services proposed, Bio Elpida can also provide training support either at our facility or at the client’s relevant location of choice. Hence, your scientist could deepen and further develop their knowledge and expertise in cell therapy, cell culture and immunotherapy.
Drug Analytical DevelopmentBio Elpida can also provide (itself or through alliances with expert organisations), analytical services to support all phases of your drug development process whether in preclinical, clinical or investigational phases:
- Characterisation Services
- Preformulation Services
- cGMP Analytical Services
- Quality Control
- Microbiology Testing
- Bioanalytical Services
- Stability Services
Bulk PurificationBased on its deep cell culture expertise, Bio Elpida can also provide bulk production and purification. We recommend using SUB (Single Use Bioreactor) and propose different production means such as perfusion by ultra filtration or continuous centrifugation or simply by batch.
Hence, Bio Elpida can also develop biomolecules purification techniques and methods such as monoclonal antibodies and antibiotics.
The different purification steps proposed are as follow:
- Bulk clarification
- Concentration and diafiltration by ultra filtration,
- Capture (charge induction hydrophobic interaction chromatography),
- First purification (affinity, ion exchange, hydrophobic chromatography),
- Finale purification (to reach a high purity degree),