Fagron is active in pharmaceutical compounding. Pharmaceutical compounding is the manufacturing of non-patent-protected or unregistered pharmaceutical preparations by a pharmacist. A pharmaceutical preparation is always prepared based on a prescription from a healthcare subscriber such as a doctor. This results in a not commercially available, personalized medicine to meet a patient’s specific needs.
Pharmaceutical compounding enables a doctor to offer a patient a personalized treatment that is not commercially available. You can think of a personalized administration form or dosage when a patient is not able to use the standard available administration forms of an existing medication, for example when a patient has a problem swallowing or is allergic to an ingredient. Another form of personalization is an alternative dosage form, such as a topical dosage in the form of a cream instead of a pill. This can reduce side effects and the potential for addiction, for example when treating pain.
What is animal testing, and is it necessary?
For pharmaceutical products animal testing can be performed on living animals to understand the effectiveness of pharmaceutical products and the safety for use of these products for humans.
Animal testing is often used in the development of new drugs or before release of individual batches of manufactured drugs (for example for vaccines derived from live products such as a polio vaccines). Animal testing often occurs in the second step of drug development. The general steps of drug development are:
- Discovery: Lab development
- Preclinical research: Computational testing and testing on cells, tissues slices, organs and living animals to prove that the drug is safe for testing on humans.
- Clinical development:
- Phase I: Testing on healthy humans, up to 100 people to understand the safety of the product
- Phase II: Testing on humans with the target disease, up to 300 people, to proof that the drug works and determine the minimum and maximum dosage of the drug.
- Phase III: Testing on humans with the target disease, 1000 people or more, to proof that the drug works based on the determined minimum and maximum dosage of the drug and is safe for use at that dosage. At this stage any side effects are determined.
- Market approval: Submission of all documentation for market approval for the product to the regulatory authority of the targeted country or region, such as the FDA (US) or EMA (EU).
In some instances, it is mandatory to conduct animal testing.
Animal testing for Fagron products
Fagron does not manufacture active pharmaceutical ingredients (APIs) or patented drugs. Fagron purchases APIs and conduct quality tests before repackages these in smaller quantities so that they can be used by our customers, or compounds APIs in combination with excipients into non-patented or out-of-patent sterile and non-sterile ready-to-administer or ready-to-use drugs. Fagron also outsources the manufacturing of a number of its products to contract manufacturers.
Fagron as a company does not conduct any animal testing nor contracts other companies to conduct animal testing for any of the products that it repackages and compounds. Also, none of Fagron’s contract manufacturers conducts any animal testing for the products they manufacture for Fagron.
This means that there are no final products that are sold under a Fagron brand (or any of the brands carried in the Fagron Group) for which animal testing has been conducted.
It is of course possible that animal testing may have been conducted at the time of development of the active pharmaceutical ingredients (often more than 5 years ago), the development of the original drug, or in academic studies not funded by Fagron.
Does Fagron use other animal products?
Unless one of our products is branded as vegan, it is possible that a product contains ingredients from an animal source or that products from an animal source have been used during quality testing. We describe two examples; horseshoe crab blood and lanolin.
Horseshoe crab blood
Products that contain or are produced with horseshoe crab are used in quality testing (endotoxin testing) for Fagron’s sterile products before they are released. The horseshow crab species are part of a pre-historic family of species that are believed to exist more than 400 million years ago. The blood of these crab species shows a strong reaction to a number of toxins. Horseshoe crab blood is bled from living horseshoe crabs, before releasing the crabs back into the wild.
There are two different products produced from horseshoe crab blood:
- LAL (Limulus Ambocyte Lysate) which is extracted from the horseshoe crab species Limulus polyphemus, a species that is not endangered.
- TAL (Tachypleus Amebocyte Lysate) which is extracted from the horseshoe crab species Tachypleus gigas (potentially endangered) and Tachpleus tridentatus (endangered)
Fagron tries to minimize its use of horseshoe crab blood derived products, but unfortunately in some jurisdictions there is no approved alternative to using these products. The two available options are:
- Using a cartridge method, that uses only 5% of traditional LAL amount
- Using the rFC test which does not contain any horseshoe crab blood. This test is allowed for use in Europe since the 1st of January 2021. In the USA a proposal has been made to allow for use of the rFC test (see USP website), but approval for use is unlikely to happen before yearend 2024. Upon approval, qualification and testing for each individual product would need to occur, which will also take some time.
Fagron[SN1] requires endotoxin testing in 8 of its sterile production facilities, four of which are situated in the USA. In addition, the Fagron laboratory in Brazil offers endotoxin testing for external parties. None of these 9 facilities currently uses the rFC test because it is such a new technology, or it is not – yet – approved for use. At six of these facilities, at least part of the quality testing occurs with the cartridge method and we are working on increasing this number. In the other facilities we are currently investigating if we can switch (i) (completely) to the use of a cartridge method to reduce the amount of LAL used, or (ii) to the rFC test in those cases where this is allowed.
Lanolin or wool fat is a type of wax used in both cosmetic and pharmaceutical products. It is most commonly extracted from sheep wool. The sheep is shaved for the wool and the wool is washed in hot water and a special detergent to extract the lanolin. Fagron sells different types of products that contain lanolin:
- Lanolin is a repackaged product for pharmacists to use in the compounding of creams
- Lanolin is used in some of the final products sold by Fagron such as Fagron Derma products in the Netherlands (with the exception of Fagron Advanced Derma products).
Follow our ESG journey
We are working non-stop to realize our targets and want to be transparent about our results and activities. Annual progress can be followed in our most recent annual report. We also report on progress during the year in the news segment on our website and on LinkedIn.
If you have any questions or suggestions on what we could do to improve, you can reach us at ESG@fagron.com.