A deep understanding of the challenges when processing highly potent drugs, such as limited solubility in water and rapid degradation, paired with long term experience and comprehensive know-how of lyophilization from various organic solvents and solvent / water mixtures enables us to provide specific solutions for cytotoxic drugs.
ProJect Pharmaceutics is a cytotoxic drug formulation company / cytotoxic drug lyophilization company which operates small molecule process development since many years.
We are one of the few CDO/CRO development companies that have the technical equipment, the safety facilities and the expertise to offer development services also on high potency cytostatic agents such as cytotoxic drugs, small molecule drugs, NCEs, generics and other highly potent drugs.
Many pharmaceutical ingredients of this class of small molecule drugs show limited solubility in water and rapid degradation during compounding, filling and freeze-drying.
We not only have the expertise and know-how to formulate and stabilize cytotoxic small molecules, but we also have our own dedicated safety laboratory with high-end freeze-drying capabilities implemented. ProJect Pharmaceutics’s long lasting experience and comprehensive know-how of lyophilization from various kinds of solvent systems, as well as liposome encapsulation, enables our customers to follow new paths in formulation and process technology for modern cancer drugs
Our development services for cytotoxics:
- Formulation development for cytotoxic and non-cytotoxic small molecules
- NCE and generics development
- Analysis of originator (generic, vacuum, gas overlay, gas type, o2 content, etc.)
- Lyophilization out of organic solvents and solvent / water mixtures
- Residual solvent analysis by HS-GC / HS-GC-MS
- Freeze-drying liposomal formulation
- Lyophilization process development
- Sterile filtration study
- Fill&finish process mock-up
- Lyophilization cycle mock-up study for pivotal tox batch
- Manufacturability assessment
- High-end freeze-drying technology
- Cytotoxics lyophilization cycle development and optimization
- Container closure system compatibility testing
- Process robustness studies and design space evaluation
- Aseptic pre-clinical pilot batch manufacturing
- Technology transfer to GMP
By means of having a class II workbench in the laboratory, applying LyoProtect® bags for lyophilization, and a powerful HOF lyophilizer pilot plant, we are capable of handling up to SafeBridge category 4 compounds.