Integrated Pharmaceutical Development Services
The knowledge and expertise acquired over many years of activity supporting research in the development of products from Abiogen’s product list, makes Pharmaceutical Development one of the strengths of the Business Manufacturing area.
Through state-of-the-art production and development expertise the Pharmaceutical Development Unit offers Clients a complete service from Preformulation to Technology Transfer for industrial production ranging from New Chemical Entities to Generics.
The GMP-approved facilities cover an area of 1500 m2 divided into:
- preformulation and formulation labs,
- analytical developments labs,
- two dedicated departments for the manufacturing of Investigation Medicinal Products (IMPs)
- a dedicated area for clinical packaging operation
- a Quality Control unit for release testing of IMPs.
- Stability rooms
Analytical laboratories, well equipped with the latest state-of-art machinery, assure the timely release of IMPs. The areas have been GMP accredited for Good Manufacturing Practices EU-GMP annex 13 since 2005.
Pre-formulation
- Drug substance characterisation
- Investigation on solid state properties of API
- pH / solubility profiles
- Forced degradation studies
- Excipient compatibility studies
- Compatibility Studies between API and container
- Blend characterisation
Formulation Development
- Formulation Development for early studies
- Prototype formulations for clinical trials
- Product Reformulation for Innovation & Product Life Cycle management
- Preliminary process identification
Process Optimization & Scale-up
- Manufacture of pivotal stability batches
- Process scale-up (from lab. to pilot scale and from pilot to industrial scale)
- Process optimization for commercial scale manufacture
Clinical Manufacturing
- Manufacturing and release testing of phase I, II, III and IV drug product
- Dedicated secondary packaging operations areas
- Dedicated storage area for raw materials and finished IMPs
Technology Transfer & Validation
- Tech Transfer from development R&D to pilot plant
- Tech Site Transfer of commercial products
- Demonstration batches
- Analytical Transfer
- Process Validation
Analytical Support, Development & Validationa
- Development and Validation of analytical methods
- Dissolution and drug-release profiling
- Specifications development
Stability Studies
- Stress testing
- Photostability testing (according to ICH)
- Formal stability (all storage condition according to ICH)
- On-going stability
- In-use stability
Regulatory Support
- IMPD (Investigational Medicinal Product Dossier)
- PSF (Product Specification File, GMP Annex 13)
- CTD Quality (Common Technical Document module 3.2 / module 3) for Product Registration
- Type IA, Type IB and Type II Variations (CE 1234/2008 regulation)
Formulation & Process Technology
- Small volume parenterals (ampoules, aseptic and terminally sterilized process)
- Blending and Granulation (High shear granulator / drier, Top spray fluid bed granulation, Fluid bed driers)
- Compression (single punch and high-speed rotary tablet presses)
- Tablet-coating (film and sugar coats)
- Capsule filling (Coni-snap® Vcaps™, DBcaps®)
- Liquid and Semi-solid (solution, suspensions, emulsion, creams, gels, lotions and ointments)
- Comparator-blinding services, including encapsulation and coating
- Placebo development for use in blinded studies
- Primary packaging in blisters, bottles and tubes
- Secondary packaging for open-label or double-blind studies
Analytical Technology
- Liquid Chromatography: HPLC system (UV, diode array and refractive index detectors), HPLC-IC system, UPLC system (UV, diode array)
- Gas-Chromatography (GC & HS-GC)
- Thin-layer Chromatography (TLC)
- Atomic absorption spectrometry (AAS)
- Absorption spectrophotometry, infrared (FT-IR)
- Absorption spectrophotometry, ultraviolet and visible (UV-VIS)
- Thermal analysis: Differential Scanning Calorimetry (DSC)
- Dissolution (automatic system)
- Potentiometric titration
- Osmolality
- Optical rotation