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There are many challenges that face companies taking an NCE into early stage feasibility testing and beyond. Some of these challenges are specific to the physical and chemical properties of the molecule in question whilst other challenges are related to the embryonic stage of development that these molecules are in (e.g. limited API). When early stage … Read more

Oral Dosage Form Development for Clinical Manufacture Producing a spray dried powder is rarely the end of developing an oral dosage form pathway. Further processing is usually required in order to create a oral dosage form that can be administered in First-in-Human (FIH) or Proof of Concept (POC) clinical studies. The selection of a dosage … Read more

Upperton Pharma Solutions are one of the very few CDMO’s that have a bespoke, fully equipped non-GMP pilot plant designed to reduce the timelines and the costs for scale up and transfer of spray drying processes into GMP manufacturing. Spray Drying Development and Scale up Formulation and early process development studies are performed in the Upperton … Read more

Analysing Biotherapeutic Formulations There is growing interest in the use of spray drying to create biotherapeutic dry powder formulations. Spray drying is becoming increasingly viewed as a more cost-effective method for enhancing the stability of thermo-sensitive molecules (such as proteins, peptides, monoclonal antibodies and vaccines). A key aspect in the successful development of dry powder formulations … Read more