A successful Drug development is judged by being efficacious, safe and quality driven. We offer a full service to secure highest quality

Selection of Contract Development / Manufacturing Organization 

Working within a global network of companies with high expertise in drug development, DWC can support identifying the right CMO to accelerate the development and mitigate risks of clinical/ bioequivalence outcome through proprietary formulations.

Development of Drug Substance and Drug Product

Development includes all dosage forms needed for New Chemical Entities or life-cycle projects. Main expertise covers solid oral forms, pulmonary and sterile products (both injectable and ophthalmic), modified release products and combination products.

Exploratory / early phase development / Pre-formulation study design

For NCE or a newly generic API’s it is often needed to overcome the low solubility and /or the low oral bioavailability prior to a start of a clinical study. Therefore, the solubility needs to be improved to maximize oral bioavailability.

For the selection of the best formulation an in-depth knowledge on adsorption/desorption and compatibility with excipients and container/closure compatibility is mandatory.

For formulation research and development of Injectables drugs the challenges during development are completely different. 

Process understanding and formulation expertise, in combination with analytical method development and validation are essential for a successful lyophilizate formulation and process development. 

Formulation and analytical method development and manufacturing process development / optimization

DWC can assist and lead in the following phases:

• Preclinical (GLP toxicology)
• Prototype of formulation screening studies
• IMP production for “First in Human” and Phase I – III Clinical studies
• Formulation/process optimization
• Scale-up/technology transfer
• Manufacturing process validation
• Commercial manufacturing support
• Analytical method development and method validation 
• Stability monitoring program 

Phase III formulation and API should be designed and applied in line with “Quality by Design”, according to the principles of ICH Q8, ICH Q9 and ICH Q10. Definition of Quality Target Product Profile, Critical Quality Attributes, Critical Material Attributes, Critical Process Parameters and finally of the Process Control Strategy is key for a successful and fast development and early market entry.