Avivia is an independent contract R&D organization in the Netherlands that offers a unique complementary range of services in the field of Pharmaceutical Formulation Product Development.
Having decades of hands-on development experience with a wide range of (complex) technologies and the complete scala of finished dosage forms, Avivia’s pharmaceutical experts are able to fully execute and/or support the development of any finished dosage form, formula or process, as well as the transfer and scale-up of a developed product to a cGMP manufacturing facility.
Once a suitable formulation has been found our next focus is to support the creation of novel Intellectual Property to protect the product in the market.
With our pragmatic and creative development mentality we deliver what a client needs. We perform best by exploring the rationale behind the request in close collaboration with your team.
In our lab facilities we can handle almost any small molecule API, including highly potent compounds, hormones, anti-infectives and controlled substances.
We specialize in oral dosage forms but also have development projects running in parenteral, intravitreal and topical therapies.
An extensive platform of technologies is present and includes aseptic filling, dry/wet granulation, tableting, spray drying, micro-encapsulation, and (hot melt) extrusion. In addition we have a full range of analytical test equipment available to support the development.
From trouble shooting to full service CMC development programs
Our flexible and experienced multidisciplinary teams offer fast-track R&D services in addition to comprehensive development programs where we take up projects from the start and deliver products tailored to the needs and interests of our customers.
Our approach is fully integrated and combines distinctive hands-on pharmaceutical and analytical development work (formulation & CMC). Besides developing new products clients approach us with development programs that have derailed or – in the worst case and despite all previous efforts – have reached a dead end in their in-house laboratories or other service provider.
We support our customers with early-phase opportunity and strategy evaluation by performing detailed literature searches and reviews, defining freedom to operate and development strategies for regulatory, patents, formulation development and manufacturing.
In the subsequent R&D phase we provide pre-clinical formulations and prototype development in combination with full analytical support.
The Active Pharmaceutical Ingredient (API) is the part of any drug product that produces the intended effects. Consequently the API characteristics are crucial for a well performing product. Avivia focuses mainly on small molecules (including peptides) and is able to improve API properties by altering for example its morphology, stability, solubility and availability.
A drug product consists of (multiple) API(‘s) and excipients and can be developed in a large range of applications. The extensive knowledge of Avivia release a variety of product possibilities ranging from parenterals to oral solutions to controlled release tablets to microcapsules to self-emulsifying drug delivery systems (SEDDS) to implant technology.
At Avivia we work in small multidisciplinary expert teams, allowing the analytical researchers to be directly involved in the process of formulation development.
For example: The knowledgeable researcher can develop effective dissolution methods, and significantly more important information can be derived from each dissolution test. Educated observations made by the researcher during and at the end of the dissolution test provide valuable data about disintegration, hydration, swelling, erosion, particle size, granulation and coating properties, floating, cone formation, sticking, etc. Discussing these observations during interactions with the pharmaceutical developer offers additional guidance in the evaluation of dissolution profiles, release mechanisms, excipient performance and setting process parameters.
Transfer to cGMP
In the final phase Avivia takes care of the investigational medicinal product dossier (IMPD), analytical method transfer, CMO selection and scale-up.