What is pharmaceutical gelatin made from?

Beyond Biopharma · Pharmaceutical Gelatin FAQ

Short answer: Pharmaceutical gelatin is made from collagen in the skin and bones of food animals, most commonly bovine skin and bone and pig skin, with fish skin or scales used for specialised grades. The choice of starting material is about far more than where the protein comes from: it drives the processing route (acid or alkali), the isoelectric point of the final gelatin, and therefore its electrical behaviour in a formulation, and it carries source-specific obligations such as BSE/TSE documentation for bovine material, religious suitability certificates for halal or kosher, and allergen-labeling considerations for fish. Every raw material must be traceable, from controlled animals fit for human consumption, before it can support the standards of pharmaceutical grade gelatin.

The raw materials

Pharmaceutical gelatin is a protein derived from collagen, the structural protein that makes up a large share of animal connective tissue. The richest convenient sources for manufacture are:

Whatever the species, the starting material should come from animals that have passed inspection for human consumption and from controlled, documented slaughter and collection chains.

Why source determines Type A or Type B

Gelatin is traditionally divided by how its collagen is treated to make it soluble. Acid-processed gelatin is called Type A and is made mainly from pig skin; it carries an isoelectric point around pH 7–9. Alkali-processed gelatin is called Type B and is usually made from bovine bone or hide; alkaline treatment converts part of the protein, lowering its isoelectric point to around pH 4.7–5.4. The practical result is that Type A and Type B differ in electrical charge at a given pH, which matters when a gelatin is expected to interact with actives, film formers or other charged ingredients. The source of the animal is therefore not incidental to gelatin chemistry — it largely decides the grade.

Bovine gelatin and BSE/TSE control

Bovine-derived gelatin sits under specific scrutiny because collagen can, in principle, carry material related to transmissible spongiform encephalopathies. In practice gelatin manufacture is widely recognised as low risk because of the processing it receives, but pharmaceutical grade still demands proof. Suppliers maintain BSE/TSE controlled source documentation, keep records of the country and origin of animals, and restrict material to bone and hide from approved suppliers. Buyers working in markets or dose forms that restrict bovine material will specify bovine gelatin carefully, and should confirm documentation with the supplier before committing to a compliant source.

Pig (porcine) gelatin

Porcine gelatin is common because pig skin is an efficient, well-controlled source that yields Type A gelatin, particularly valued for hard two-piece capsules and for certain softgel work. For customers who must respect halal or kosher dietary rules, porcine material must be excluded and the gelatin should carry an appropriate certificate from an accepted authority. Because religion and origin rules vary by market, the species statement itself — clear, uncertified labelling that the gelatin is porcine — is the first thing a formulator checks.

Fish gelatin and allergens

Fish skin and scale gelatin offers a useful alternative where porcine or bovine material is not wanted. It tends to melt and gel at lower temperatures than mammalian gelatin, which is an advantage in some encapsulation and coating applications and a handling consideration in others. Because fish is a recognised allergen in many regions, labelling must disclose it wherever the finished medicine is made available to end users. Anyone considering fish gelatin should confirm with their regulatory affairs team how fish allergen is treated in the target market.

Religious suitability, allergens and traceability

Three non-chemistry concerns regularly shape raw-material choice. First, religious suitability: halal and kosher compliance requires certified, appropriately sourced material and, for halal in particular, proper handling of the supply chain. Second, allergens: mainly fish, and less commonly egg or other sources if they ever appear. Third, traceability: pharmaceutical quality expects an auditable line from slaughter source through processing to the finished lot, so a recall or a customer question can be resolved to a specific raw material supply. These are managed by the supplier’s documentation and by the statements on the certificate at delivery, and buyers should confirm details that matter to their own market.