Let us get your ideas on the right track
From first feasibility studies with simple formulations until the marketed product, we can offer the whole range of dosage form development. To reach our target quick and safe, we have established certain ways of working that ensure that all critical parameters are considered. We follow the quality by design approach and reflect challenges in a holistic way before we approach them. We set up target profiles, carefully evaluate processes and materials and rationally design experiments. If possible, we try to evaluate many components in a short time and use different high-throughput-screening methods and DoE tools. We have far-reaching expertise in developing and establishing the desired analytics and we deliver reliable results.
Safety is an important aspect these days. As we consider ourselves a modern and responsible company, we don`t only try to protect our employees but our environment as well. If desired, we support you with a network of internal and external experts regarding toxicological characterisation of your compound to ensure product safety in every aspect.
Drug Substance Characterisation
In case stress studies have not yet been carried out on your drug substance and storage stability or degradation pathways are unknown, we can support you with a broad range of possibilities.
Stability batches and studies
As soon as the first promising formulation candidates are identified, they have to prove themselves under different conditions. We can ensure for many products that at an early stage manufacturing and filling processes reflect later production scale conditions, even though only limited amounts of drug substance are available. Besides, we are capable to work in a low particle environment to manufacture representative stability samples. Our packaging development experts ensure selection of the appropriate primary packaging.
From -80°C upwards, we can store stability samples in a broad range of qualified freezers, fridges and climate chambers.
Scale-up, tech-transfer and external partners
In many cases, we can manufacture the amounts of samples for preclinical or clinical studies ourselves. In other cases, we collaborate with longstanding audited partners and have the experience that it takes to transfer processes and analytics.
Clinical trial supplies
We have established many production processes for the manufacturing of liquid and solid dosage forms for clinical trial supply. In addition, we have longstanding experience in the manufacturing of highly complex or very sensitive biological drug products. Depending on the requirements of the respective clinical phase, we provide the appropriate production environment, technical equipment, excipients and analytical methods. Our BfArM- and FDA-approved quality assurance system ensures the fulfilment of current GMP requirements. The release of clinical trial supplies is accomplished by our EU qualified persons.