We offer commercial manufacturing of small molecule products including niche therapies like oncology, orphan and pediatric indications.
Development of novel radiolabelling method - AAPS 2013
Development of novel radiolabelling method for low dose drug products for investigation of in Vivo performance in gamma scintigraphic studies.
A rapid in vitro screen method
A rapid in vitro screen method for assessing the potential for precipitation of solubilised drugs in the small intestine.
Working with Short Shelf-Life Products in Clinical Development
Working with Short Shelf-Life Products in Clinical Development – Driving Efficiencies and Overcoming Challenges
Delivery of Antibodies to the Gastrointestinal Tract for Local Action
There has been increasing interest in the oral administration of antibodies for localised treatment of infections or other conditions in the gastrointestinal (GI) tract.
Intravenous and Oral Microdose Pharmacokinetics
Intravenous and Oral Microdose Pharmacokinetics of Three Novel Inhibitors of FabI in Healthy Subjects
Biosimilars: A Transatlantic Drift?
With the first generation of biotherapeutics agents now nearing or having reached patent expiry, the potential for follow-on biotherapeutics is now presenting industry and regulatory bodies with novel challenges.
Intravenous studies in man
Intravenous studies in man: Teasing apart absorption and clearance drivers of pharmacokinetic variability and dose and time dependent non-linearity
Adaptive manufacturing: a new paradigm to improve efficiency and effectiveness in early oncology development - AAPS 2014
There is an unmet need in the industry for a more efficient and flexible approach to provide drug product for early clinical studies. Presented here is an innovate approach to overcome these challenges by utilising a real-time, adaptive manufacturing and supply platform.
Flexible strategies for the conduct of human metabolism studies with oncology molecules - ISSX 2014
The key objectives of human ADME studies are to evaluate mass balance, determine the routes and rates of elimination and gain an understanding of the metabolic fate of the drug.
Conduct of clinical ADME study for Vosaroxin in oncology patients - AAPS 2015
Conduct of clinical ADME study for Vosaroxin in oncology patients via real-time adaptive manufacture of intravenous drug product.
Application of Translational Pharmaceutics® to reduce time, cost and risk in the early development of inhaled drug products - RDD
The efficiency and effectiveness of new drug development has remained problematic over the last decade. Translational Pharmaceutics has emerged as a new paradigm to improve R&D productivity.