Frequently Asked Questions
The questions we hear most often from prospective partners about SpectrumX pharmaceutical manufacturing.
Visiting & Getting Started
Can we visit the facility?
Yes — contact us to arrange a facility tour and meet the team.
How do we start working with SpectrumX?
There is no single route through SpectrumX. Speak to us about your product, technical requirements and commercial objectives — we then bring together the appropriate combination of development, manufacturing, regulatory and supply capabilities around your programme. Start with a conversation.
When can technology transfer discussions begin?
Technology transfer discussions and documentation review can begin at an early stage of programme planning.
Capabilities
Do you manufacture unlicensed medicines (Specials)?
Yes. SpectrumX's core pharmaceutical manufacturing proposition includes unlicensed medicines manufactured under its applicable MHRA authorisation. The site supports sterile and non-sterile Specials, subject to applicable legal, regulatory, technical and quality requirements.
Do you support Controlled Drugs?
Controlled Drug activities are supported within applicable authorisation scope. The facility maintains dedicated infrastructure and enhanced security controls, including a physically segregated, access-controlled Strong Room for the secure storage and management of Controlled Drugs.
Do you offer terminal sterilisation?
Yes. SpectrumX's pharmaceutical manufacturing infrastructure includes autoclave capability supporting terminal sterilisation where appropriate to the product and manufacturing process — up to 10,000 terminally sterilised ampoules and vials per day, supported by 100% visual inspection and container closure integrity testing (CCIT).
Do you offer aseptic filling?
SpectrumX's aseptic filling capability is installed and in final qualification within our existing UK sterile pharmaceutical manufacturing facility — an ORABS aseptic filling line with a Grade B/A filling environment. Technology transfer discussions and programme planning can begin ahead of future commercial aseptic supply, subject to successful qualification, regulatory approval and product-specific validation requirements.
Still have questions?
Our team is ready to discuss your programme and answer any questions about our manufacturing capabilities.