Optimising the Oral Solid Dose Manufacturing Process
Discover the importance of optimising the oral solid dose manufacturing process.
Discover a science-led approach with unparalleled project delivery.
As a leading Contract, Development and Manufacturing Organisation (CDMO) our defining traits lie in our adaptability and nimbleness, enabling rapid product introduction.
Through a science-led approach we align to your drug development needs from pre-clinical to late phase commercial manufacture.
With more than 25 years of experience, count on us to navigate the complexities of your project with precision, expertise and our unique approach to project delivery.
Our team support you at each stage from pre-clinical to market, with phase-appropriate solutions and expertise.
Pre-Clinical Development
Formulation development, prototype screening and stability, method development and qualification.
Phase 1 -2 Clinical Supply
Phase 1 – 2 clinical manufacturing, QC testing, ICH stability, Qualified Person Release, Clinical Stability.
Process Scale-Up for Phase 3
Process robustness (DoE), method validation, cleaning validation, ICH stability, QP release.
Registration
Scale-up and batch manufacture, NDA/BLA submission, process QbD, full stability studies, risk assessements.
Process Validation & Launch
Manufacture of launch supplies, stability studies, NDA QC dissolution method and CR dissolution.
Regulatory Support
CMC strategy, gap analysis and classifications, regulatory agency support, marketing applications.
Our project teams are made up of subject experts from across our business. With oversight from an Executive Leadership Team member on every project, our approach ensures we can make decisions quickly, collaborate, and leverage expertise across our business to navigate complexities and ensure your project’s success.
Passionate about science, we strive to build strong customer relationships and exceed their expectations.
We develop and manufacture high-quality drug products and share in our customers’ dedication to change the lives of patients.
Our extensive expertise encompasses the development, scale-up, manufacturing, and rigorous testing of oral, pulmonary, and nasal drug products.
Our flexibility ensures that we can problem-solve, meet your timescales, and deliver solutions that meet patient targets.
As a leading Contract, Development and Manufacturing Organisation (CDMO) our defining traits lie in our adaptability and nimbleness.
Through our science-led approach we align to your drug development needs from pre-clinical to late phase manufacture, across oral solid dosage forms, liquids, semi-solids, nasal and inhaled products.
Our team support you at each stage of your drug program lifecycle from pre-clinical to market.
Our CDMO services include formulation development, phase 1, phase 2 and phase 3 clinical supply, process scale-up and optimisation, quality control, analytical development and validation, and registration activities.
Our project teams are made up of subject experts from across our business. With oversight from an Executive Leadership Team member on every project, our approach ensures you can have open and transparent conversations, enabling quick decision-making and collaboration across our business to ensure your project’s success.
Our award-winning 50,000 sqft development and manufacturing facility, Trent Gateway, enables our teams to be flexible and nimble so that we can problem-solve, meet your timescales, and deliver solutions that meet patient targets.
Discover the importance of optimising the oral solid dose manufacturing process.
Upperton honoured at Sunday Times 100 Fastest Growing Companies ceremony.
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Trent Gateway, Technology Drive, Beeston, Nottingham, NG9 1LA, UK. Phone: +44 (0) 115 855 7050 Email: contact@upperton.com
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Speak with our team of experts and set up a discovery call to discuss your project in more detail.