Supporting The Unique Needs Of Your Sterile Injectable With Exact SI-ence

Many therapeutics — from monoclonal antibodies (mAbs) to cytotoxic compounds for oncology treatments — require delivery via sterile injection. Offering benefits such as avoiding the harsh conditions of the gastrointestinal tract and first-pass metabolism, this administration route is ideal for a wide variety of drug modalities. Sterile injectables can enable rapid delivery of the therapeutic to the target via the bloodstream while providing better bioavailability and more reliable dosage than oral dosage formats. Drug modalities utilizing this administration route all require aseptic processes and sterile fill-finish to ensure patient safety and therapeutic efficacy.

However, the growing number of innovative modalities like novel vaccines, antibody drug conjugates (ADCs), and gene and cell therapies (GCTs) entering the market are adding complexity to the development and manufacture of sterile injectable therapeutics. And while drug delivery systems offer certain advantages for improving the stability and specificity of sterile injectables, realizing the potential of these delivery systems requires extensive expertise. Leveraging the experience and specialized technology of a reliable contract development and manufacturing organization (CDMO) partner is essential to ensure your product’s sterility and quality while delivering at speed.