Is There a Single-Use Solution for ADC Processes?

A Highly Demanding Process for ADCs

What happens when an antibody is linked to a cytotoxic compound? You get an antibody-drug conjugate (ADC), which is commonly used in cancer treatments. ADCs work by coupling an anticancer drug to an antibody that specifically targets a certain antigen on the target tumor. The drug then acts on tumor cells to kill or disable them.

The process for manufacturing antibody drug conjugates typically involves the use of solvents such as N, N -dimethylacetamide (DMA), N, N ‑dimethylformamide (DMF), dimethyl sulfoxide (DMSO), or propylene glycol (PG) to dissolve the drug so that it can link – become conjugated – to the protein.

These solvents are difficult to store and handle due to their being highly volatile and corrosive. That means specialized materials must be used for the ADC process.

However, it is difficult to perform this process in standard tank-based systems made from specialty materials – much less single-use systems.

Materials with the required characteristics simply do not exist in standard single-use containers that are typically manufactured from PP (Polypropylene), PE (polyethylene), PETG (Polyethylene terephthalate glycol) and PC (Polycarbonate). None of these materials would be able to contain the solvents involved.

The Purillex^® Difference

Savillex has developed a lineup of Purillex^® ready-to-use bottles and stability vials for critical, final product applications – including ADC processes.

Our bottles are made using materials well-suited for solvents, acids, bases and other corrosive materials. At the same time, Purillex^® bottles are pure, clean, and non-reactive for the ultimate assurance that your drug substance will be safe.

Purillex^® bottles are available in PFA, FEP and ETFE materials and offered pre-sterilized for convenience and ease of use.

Here’s a quick breakdown of Purillex^® bottle benefits for ADCs

• Compatibility with all solvents, acids and bases
• Inert and gentle on your product
• Clean, sterile and ready-to-use
• Sizes from 3 mL to 2000 mL
• Available with tubing, connectors, dip tubes and other integration features

Seeing as how you’re interested in ADC processes and single-use systems, be sure to learn even more about the complete lineup of Purillex^® bottles and stability vials online. For additional technical information, or to obtain pricing, please give us a call today.