Case Study
Field: Pharmaceutical
Background
A young pharmaceutical company who develops a new anti cancer product for Leukemia treatment. The company successfully past the per-clinical stages and was looking towards phase I and phase II.
Challenges
- Transfer of laboratory uncontrolled and mini-scale production to GMP large scale
- Equipment specifications
- Pharmaceutical product manufacturing risk assessment
- Pharmaceutical process development
- Equipment and machinery purchasing
- Pharmaceutical process engineering
- Technology transfer and experimental batch manufacturing
- Equipment validation
- Process Performance Qualification
- Cleaning validation and verification
- Storage and shipment validation
- Clean room validation
- Water system validation
- GMP documentation
Testimonial
“Bio-Chem led Tiltan Pharma production for several years and various formulations.They were very professional and instrumental in the preparation for production as well as in the actual production work. Eran was doing all that with a smile, even after long (sometimes very long) hours of work and facing non-trivial challenges”
Dan Goldstaub
Clinical Research Director at MSD
Clinical Research Director at MSD