1. Pharmaceutical formulation
One of the first steps after selecting an Active Pharmaceutical Ingredient1 (API) for development is to find the best way of delivering the molecule. Knowledge around delivering technologies resides within the Pharmaceutical Formulation Department. The formulation work is usually divided into two phases – early and late stage formulation.

Early stage formulation focuses on producing simple, but suitable products for use in toxicological2 and early clinical testing. In parallel the API undergo a series of physical and chemical testing to learn about the stability of the API under different conditions.

Late stage formulation work focuses on fine tuning the formulation that eventually will be the final medical product to be marketed. In between the formulation will have undergone development from bench scale to pilot scale and finally to production scale, known as process development. In parallel the final formulation will undergo extensive long term stability testing.

2. Process development is the method whereby the pharmaceutical formulation is translated into a reproducible production process. There are several scales of production when attempting to reproduce a molecule:

• Bench scale – a molecule is developed for the first time in the lab often using experimental methods;
• Pilot scale – an attempt is made to systematise the production of the “experimental” molecule in order to be able to reproduce it exactly on a small scale;
• Production scale – the processes developed in the pilot scale are amplified in order to be reproduced on a large scale on a production line rather than in a lab.

Ferring has an exceptionally broad knowledge within pharmaceutical formulation and is working with small molecules, peptides3 and recombinant4 products. Ferring’s original knowledge base has been and still is formulation of peptides3 including technologies such as freeze-drying, micro-encapsulation and device technologies. From there Ferring has expanded into small molecules and more specialised formulation technologies like oral lyophilisates (MINIRIN® Melt) and self forming depot products like FIRMAGON®. 

3. Pharmaceutical analysis
Pharmaceutical analysis is a support function for pharmaceutical formulation, which means that the two departments have to work very closely with each other. The main focus in pharmaceutical analysis is developing the necessary analytical methods to confirm the chemical structure of the API, its content, purity and quality and the pharmaceutical formulations used during the development of the medical product from early stage to hand-over to quality control in production. Ferring’s diverse project portfolio calls for an in depth knowledge of a broad range of analytical techniques covering small molecules, peptides3 and recombinant4 products.

4. Pharmaceutical maintenance
Pharmaceutical maintenance covers the life cycle aspect of the developed medical product and comprises continuous support from pharmaceutical development to production technical department or directly to production. The emphasis here is on constantly improving the process within the frames of the approval from the authorities.

Non-clinical development
During non-clinical development, experts such as pharmacologists and toxicologists carry out in-vitro and in-vivo tests to ascertain the safety and prove the pharmacological efficacy of the compound. The studies performed provide information on the mechanisms of action resulting in a pharmacological effect, and how the new drug interacts with the systems of living bodies.  In particular the tests are designed to detect unwanted side effects of administration, either pharmacological or toxicological.  This data is important for determining if the new drug is safe for clinical administration, and also provides information on dosage and route of administration. Ferring collaborates with commercial, academic and government laboratories to undertake non-clinical testing.

Clinical development
Clinical development is the phase of the product development stage when the potential new drug is subjected to detailed clinical testing which involves human clinical trials. Relevant regulatory authorities set out the nature of the clinical trials which Ferring is required to undertake and these trials are strictly controlled.

Being an international company, Ferring undertakes clinical trials simultaneously in the EU, USA and Japan, in order to meet the regulatory requirements of all three regions.

Clinical testing happens in three phases:

Early stage development

• Phase I – trials are carried out in healthy volunteers to determine the biological properties of the potential new drug and its tolerability in humans.
• Phase IIa – trials are conducted in a small number of patients in order to undertake a preliminary assessment of efficacy and safety

  Late stage development

• Phase IIb – trials are conducted in a larger range of patients to determine safe and effective doses
  

• Phase III – full scale clinical trials are undertaken often involving thousands of patients in different locations across the world to establish the final efficacy and safety of the new drug and to monitor and evaluate its longer term safety

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