PART I: HPAPI Market Forecasts and Manufacturing Challenges

In this two-part blog series, Alcami Senior Director of Global Manufacturing Science and Technology, Adam Kujath, discusses the market forecasts and the main manufacturing challenges involving highly potent APIs.

The highly potent active pharmaceutical ingredient (HPAPI) market is one of the fastest growing CDMO submarkets, approaching a 9 percent compounded annual growth rate (CAGR). There is a continued industry focus on pipeline development oncology drugs, which by nature of indication is producing compounds that are increasingly potent.

Topics: Thought Leadership API HPAPI Manufacturing HPAPI

White Paper: Optimizing HPAPI Manufacturing Performance

Outsourcing highly potent active pharmaceutical ingredient (HPAPI) development and manufacturing is reaching an all-time high thanks to an increased demand of highly-targeted new drugs with greater efficacy at lower doses and the price of investment to handle internally. Several factors will dictate the performance of a contract development and manufacturing organization (CDMO) when handling HPAPIs. It is not merely a question of having the physical assets for high containment; outsourcing of a specialized and potentially challenging piece of the supply chain requires partnership and collaboration between the CDMO and sponsor. Any relationship is reliant upon transparency, team cohesion, and a level of experience that ensures a collaborative understanding with effective communication. Ultimately, success relies upon the equipment, experience, and a right-first-time ethos. Consider the factors discussed in this white paper when evaluating a potential CDMO partner.

Topics: Resource Center API HPAPI Manufacturing HPAPI Thought Leadership

ON-DEMAND WEBINAR: Balancing HPAPI Control with the Chemistry and Efficiency Needs of a CDMO

Effective high containment API manufacturing has certain expectations and requirements; similarly, being a successful contract development and manufacturing organization (CDMO) has its own distinct challenges. When the demands of these two worlds meet, the ability to balance both offers a unique challenge.

Topics: Webinars API HPAPI

8 Characteristics of a State-of-the-Art Highly Potent API Facility

HPAPI manufacturing is a demanding enterprise, but given the robust growth within this segment of the pharmaceutical industry, it is critical to have the right facilities and capabilities in place. Alcami has been dedicated to this pursuit, and our efforts culminated in the opening of our Germantown, WI, HPAPI facility. It is unquestionably state-of-the-art, so we took the opportunity to reflect: Which characteristics make it an industry-leading HPAPI facility?

1. State-of-the-art containment
Highly effective containment is the most important aspect of designing an HPAPI facility.
While many high-potency manufacturers rely on personal protection equipment (PPE) for primary control, PPE should be a secondary or even tertiary measure within a state-of-the-art facility.

Topics: Thought Leadership HPAPI

ON-DEMAND WEBINAR: Approach to HPAPI Suite Design in a Multi-Use Facility

Join Alcami for a webinar to learn more about the design approach to highly potent active pharmaceutical ingredient (HPAPI) suite design in a multi-use facility.

As new drug targets naturally become more potent in the search for more effective therapeutics, there is a growing demand for capacity and capabilities in support. The development and manufacture of Highly Potent Active Pharmaceutical Ingredients (HPAPI) in a multi-use facility faces challenges of technical, procedural and a perception-based nature. Fundamentally, it all starts with the use of the right tool for the job.

Topics: Webinars HPAPI Manufacturing HPAPI CDMO API

Have a Highly Potent API? Here's What You Need to Consider

Given the risks highly potent active pharmaceutical ingredients (HPAPIs) present in cross-contamination and containment, it is important to consider manufacturing and handling approaches carefully. In fact, because of the demands of HPAPI manufacturing, many drug developers select a contract development and manufacturing organization (CDMO) partner to make the substance. The discussion below outlines some of the considerations for HPAPI manufacturing and, when appropriate, HPAPI CDMO selection.

HPAPI Manufacturing
With the significant infrastructure and capital investments required for effective HPAPI manufacturing, it is simply not feasible for many of the small and mid-size companies to make this extensive investment. In the suites alone, Alcami is investing approximately $7 million in 2017. Not to mention its investment in skilled personnel and procedural development. These levels of investment are not possible or prudent for many companies.

Topics: Thought Leadership HPAPI

At-A-Glance: Highly Potent API

The highly potent active pharmaceutical ingredient (HPAPI) market is growing rapidly with no signs of slowing down. But what is it, how is the market changing, and what are the expected trends in this space?

What Is HPAPI?

HPAPI is generally defined as:

  • A pharmacologically active biological ingredient or intermediate with activity at approximately 150 µg/kg of body weight or below in humans (therapeutic daily dose at or below 10 mg)
  • An API or intermediate with an OEL at or below 1µg/m3 of air as an 8-h time-weighted average
  • A pharmacologically active ingredient or intermediate with high selectivity (i.e., ability to bind to specific receptors or inhibit specific enzymes) and/or with the potential to cause cancer, mutations, developmental effects, or reproductive toxicity at low doses
  • A novel compound of unknown potency and toxicity
Topics: Thought Leadership HPAPI