This week we kick off a new series of Fun Science Friday volumes that focuses on AbbVie’s global manufacturing network. After all, manufacturing brands that treat 75+ conditions and 50 million patients each year isn’t possible under just one roof!
Today we’ll focus on the different capabilities in AbbVie’s network. In future weeks, we’ll cover specific sites in depth.
Recall that a biologic is a large molecule protein or toxin that has therapeutic effects. The molecule of interest is first grown within the cells and then separated using various chromatography and purification technologies.
Biologics sites are responsible for producing this purified molecule, which is called the Bulk Drug Substance (BDS). To do this, they utilize working cell banks , bioreactors, and various chromatography and purification methods.
The active pharmaceutical ingredient is the compound within the medication that produces the therapeutic effect. You can think of it as the small volume equivalent of biologics BDS. Unlike biologics, small molecule APIs don’t utilize cells to produce the compound of interest. Instead, chemical synthesis is used.
API sites utilize techniques such as fermentation, catalysis, and distillation to control chemical reactions that occur to produce the compound of interest. All products that are in tablet or capsule form utilize APIs, so there are too many brands to picture for this type of manufacturing!
Within AbbVie’s network there are various types of medical technology sites! These can be broken down into the categories listed below:
Device Molding and Manufacturing Sites – make various components that are assembled to build medical devices such as autoinjectors.
Electro-Mechanical Device Manufacturing Sites – specialized sites used to build and service devices such as pumps and inoffice machines used to administer treatments.
Regenerative Medicine and Implant Product Sites – utilize human and porcine tissue to build skin grafts/meshes or mold silicone to produce implants.
Drug Product is the final formulation of a medication. It can be either a Parenteral (a compound taken without the use of the mouth—usually via an injection or eye drops) or an Oral Dosage (capsule, tablet, liquid you swallow). In both cases, sites use techniques like blending, milling, extrusion, and mixing to achieve the final formulation. Read on to learn more about the differences between the two!
Sites with parenteral capabilities manage the process of formulating the Bulk Drug Substance into the final liquid Drug Product and filling the DP into syringes, cartridges, bottles, ampoules or vials. In some cases, further processing, such as Lyophilization is needed to keep the product shelf stable.
These sites have very high cleanliness standards, as the filled solution is required to be free from contamination.
Oral dosage sites encapsulate or compress the final drug product into a capsule or tablet. Some sites also fill oral liquids into bottles, similar to a parenteral site. Many of these oral liquids are pediatric dosages.
While packaging may be the most self explanatory of the different site capabilities, it certainly doesn’t mean it’s a simple process! AbbVie’s packaging sites use highly automated and complex equipment to package the medication into various configurations such as blisters, bottles, syringe kits, and sachets. This is the final step before the product goes to our patients.
There are WAY too many brands to picture here, as AbbVie’s packaging sites touch nearly every product the company produces!
