HIGH POTENCY MOLECULES

Highly potent drugs are increasingly common in pharmaceutical development.  The oncology field is especially active – approximately one-third of all new drug approvals are cancer medicines.  In addition, other therapeutic areas where drugs may be highly potent include hormone treatments and neurology indications.

The challenge with development formulations of high potency drugs is i) in the handling and containment of the drug substance to ensure operator and facility safety, and ii) in ensuring the homogeneity of the drug product. As each program is uniquely different, a CDMO has to evaluate each project on a case-by-case basis.

For safe handling of highly potent — and often highly toxic — materials, current practices often focus on containment using isolator technologies.  Isolator technologies offer protection for the operator and processing environment.

Consideration also has to be given to the practicalities of producing a homogeneous batch of product with unit doses containing very small quantities of drug.  One approach is to incorporate the drug in a liquid vehicle and then to encapsulate the liquid in a capsule.  This reduces exposure risk to the operator and an excellent opportunity to achieve satisfactory uniformity of dose for low-dose products.  Another approach is to produce a wet-granulation formulation to distribute the drug throughout a powder for tabletting. A wet-granulation process approach pre-dissolves the drug in a solvent, and the solvent is removed by tray or fluid bed drying.  Ascendia has the capability to conduct either approach for formulating potent molecules.