From Development to Manufacture
SpectrumX's R&D and technical capability connects pharmaceutical development with practical manufacturing.
Our technical teams support partners in progressing suitable products towards robust, repeatable and scalable manufacturing processes.
Scientific & Feasibility
- Product feasibility assessments
- Literature reviews
- Scientific assessments
- Solubility studies
- Excipient compatibility studies
- Initial formulation candidate screening studies
- Filter compatibility studies
- Packaging compatibility assessments
Product Development
- Sourcing of appropriate materials including APIs, excipients and packaging
- Formulation development
- Bespoke product development
- Extended shelf-life product development
- Preservative efficacy testing
- Nitrosamine risk assessments
Technology Transfer & Scale-Up
- Inbound technology transfer
- Outbound technology transfer
- Scale-up activities
- Engineering trials
Validation & Optimisation
- Full process validation
- Formulation/process optimisation
- Development report writing
Our R&D and technical capabilities can be configured around the requirements of the individual pharmaceutical programme.
Process Development
Development and optimisation of manufacturing processes, including process parameters, equipment suitability and scale-up considerations.
Technical Transfer
Support for transferring products and manufacturing processes into the SpectrumX manufacturing environment. Technology transfer discussions and documentation review can begin at an early stage of programme planning.
Scale-Up Support
Support for moving suitable products from development and pilot activity towards validated commercial-scale manufacture.
Scale-up and validation support includes
- Manufacturing feasibility
- Process optimisation
- Equipment assessment
- Process validation
- Cleaning validation support
- Hold-time assessment
- Technical investigations
- Deviation/CAPA technical support
- Continued process improvement
Looking for a Sterile Pharmaceutical Manufacturing Partner?
Whether you are developing a new product, transferring an existing programme, preparing for scale-up or looking for a long-term manufacturing partner, speak to SpectrumX about your requirements.