Custom Development and Manufacturing
Farmabios provides custom synthesis services for the development and commercial manufacturing of New Chemical Entities (NCEs) and commercial APIs. Farmabios has specific expertise in steroids chemistry and Highly Potent APIs.
Our services include:
- Analytical research and development
- Process development & optimization using a broad portfolio of standard and advanced proprietary technologies
- Production from kilo-lab to multi-ton commercial scale
- Supply chain optimisation and continuous improvement
- Stability testing and forced degradation studies
- Regulatory project management including worldwide regulatory registration support
- Supply chain optimisation and control
Farmabios operates with full transparency and accessibility, with our customers’ needs driving the process. Our project managers will work closely with you to ensure project teams are aligned and informed throughout the lifecycle of the project.
Farmabios process development services are built to deliver scalable and robust synthetic routes under tight timelines. Farmabios provides you with the appropriate solution that meets your expectations for quality, quantity and regulatory compliance We scale up your chemistry and, if needed, we can develop and optimize alternate synthetic routes.
Our process development services include:
- Chemical route selection
- Process optimization and scale-up
- API particle control (i.e. polymorphism, tailor-made particle size distributions and crystal shape)
- HSE assessment
- Process validation
We develop and implement robust analytical methods for application in daily routine environment and for validation and transfer under GMP with the following LC-equipment: HPLC/UPLC in combination with UV, RI and ELSD-detection: GC-equipment: GC and GC-HS, GC-MS.
Other specialized analyses are performed with our long-standing partners at private or university research centers.
Intellectual Property Rights
Farmabios has the inherent right to protect its know-how, expertise and competitive advantage including sales-figures, marketing data and business strategies. Accordingly, Farmabios respects and protects the intellectual property rights of third parties.
Employees are trained to uphold our Intellectual Property Policy and disclosing procedures. They are obliged to protect company proprietary information, unless authorized to do so. This obligation applies to current and former employees.