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Potent Product Manufacturing in a Multi-product Facility

Highly potent drugs are becoming increasingly common in the drug development pipeline. The focus on oncology, rare diseases, and targeted therapies is growing even more acute. While highly potent compounds have benefits in treating many medical conditions, companies with promising highly potent active pharmaceutical ingredients (HPAPIs) can face significant challenges when it comes to using them in development and manufacture. Key challenges in bringing them to market include ensuring that workers and the environment are protected from exposure, and, in a multi-product facility, delivering adequate, compliant controls to mitigate the risk of cross-contamination.

Historically, most of these potent compounds have demanded dedicated facilities, and separate dedicated equipment to manufacture them safely. But, with more of these compounds entering the market, the economics that supported this strategy is not always financially viable, especially for developers of novel compounds for smaller patient groups. Fortunately, pharma’s innovators have access to the flexible cost-efficient multi-use capacity they need from the contract development and manufacturing organisation (CDMO) industry. However, introducing and transferring an HPAPI compound to a CDMO partner’s multi-use facility presents unique challenges that need to be overcome in order to sustain worker safety and prevent cross-contamination.

Highly Potent Products require a Rigorous Containment Strategy

An important initial step when developing and manufacturing any HPAPI drug substance and drug product is to properly assess and categorise these complex compounds and then develop an appropriate containment strategy to manufacture them safely. Unlike in a dedicated facility where the containment strategy is set for a single compound, in a multi-use facility each new program demands this initial and critical risk-based assessment before work can commence.

Although the characteristics that define what constitutes an HPAPI compound are commonly shared by manufacturers, the systems for rating their potency to assess risk are varied. The rating system used – and how it is applied – will also differ from site to site, and between host manufacturers and their CDMO partners. And this is where conflict can occur. Some negotiation is required to arrive at the correct classification of the HPAPI material in question. Most pharma manufacturers use either a five-, or six-band system with the containment numbers between company A and company B differing slightly.