Evotec provides a one-stop solution for drug product development through all its stages in a rapid and efficient way.
Our scientists work hand in hand with clients to design and execute the best development strategy for rapid and efficient entry into crucial First in Human studies and further advancing for clinical supplies of drug product to Phase II and Phase III studies.
Our Formulation and Clinical Manufacturing groups have consolidated experience in screening, optimising and scaling-up formulation and manufacturing processes for oral, solid and drug powder inhalers (DPI) dosage forms.
In addition to the development of dosage forms for readily bioavailable active ingredients, significant expertise, experience and a broad range of state-of-the-art enabling technologies are available for the development of drugs requiring bioavailability enhancement.
Formulation screening starts with the characterisation of physical-chemical and biopharmaceutical properties of the new chemical entities with a close interaction between Formulation, Analytical Development, Material Sciences and Biopharmaceutics teams. This multidisciplinary collaboration has a significant positive impact on the success rate and duration of the screening phase, especially for active ingredients requiring application of bioavailability enabling technologies.
Small amounts of prototypes are prepared to evaluate the performance of the dosage form according to the agreed Target Product Profile and to preliminarily assess their chemical and solid-state stability under stress conditions.
The application of our Accelerated Stability Assessment Program (ASAP) approach allows us to reduce duration and increase the amount of information available for stability studies. View our Analytical Development and Quality Control capabilities to learn more about ASAP.
A wide range of in vitro testing methods can be applied, with an expertise in developing and using discriminatory dissolution tests with bio-relevant media.
If in vivo testing in animal is needed, the co-location of the Animal Science Team allows for quick and straightforward selection of the most relevant target animal species and study design, depending on the drug product properties under evaluation.
The transfer of the selected prototype production to GMP facilities is enabled and facilitated by the availability of representative or equivalent equipment in the development laboratories: at least one demo batch is manufactured to confirm suitability of the process.
Evotec is a pioneer in process scale-up and validation implementing the principles of ICH Q8 and ICH Q9 guidelines, FDA 2011 guidance on process validation and annex 15, enabling continuous process of development through all the clinical phases, with accurate data collection and documentation compliant to the standard required for CMC dossiers. The expertise of a task force of scientists officially qualified for Quality by Design (QbD) is applied to design and implement full development, registration and process performance qualification plans or for the technology transfer to our manufacturing facility of externally developed formulations and processes.
And last but not least, because of the approval for commercial manufacturing at Evotec site the right combination of flexibility and equipment scale, typical of clinical manufacturing, is available to support also production for the market of niche and orphan drug products.
Our Special Capabilities
Quick in humans
- API in capsules: Xcelodose™ precision dosing
- API in bottles
- Ready to use nanosuspensions
- Simple blends in capsules: precision dosing capsules fillers
Bioavailability enhancement
- Nanosizing: top-down and bottom-up technologies
- Solid phase modification: amorphous solid dispersion, solid solution
- Self-emulsifying systems
Dry powder for inhalation
- API characterisation and particle size engineering
- Precise filling technologies
- Reverse engineering of innovator DPI products
Patient centric approaches
- Multiparticulate: granules, pellets, powder for reconstitution
- Sprinkable capsules
- Nasogastric delivery
- Orally dispersable tablets
- Taste masking: by coating, by sweetening/flavouring
Modified release
- Multiparticulate systems: coated pellets
- Coated tablets
- Matrix tablets
- PK-PB studies: Gastroplus modelling
Our Manufacturing Technologies
- Dry granulation: clinical manufacturing
- High shear and fluid bed wet granulation: clinical and commercial manufacturing
- Hot melt granulation: clinical manufacturing
