Highly Potent APIs (HPAPIs) - Handled With Care

Handling highly potent APIs is no easy feat, but at Pii, we’ve got it down to a science. We manage the risks and complexities with tailored solutions, ensuring every step of your HPAPI development is safe, efficient, and precise. When it comes to HPAPI manufacturing, we’re here to deliver—no guesswork, just results.

Let’s Tackle Potency Together

HPAPI Solutions that Pack a Punch

Benefits

Capabilities

At Pii, we specialize in the high-stakes world of HPAPI manufacturing with

Integrated development and manufacturing services: streamline your path to market.
Comprehensive safety protocols: protect both people and products.
Experienced HPAPI team: passion for the potent.
Advanced analytical capabilities: validate cleaning and prevent cross-contamination.

Fully PPE-covered Pii scientists working on HPAPIs in a sterile lab environment.

Get precision-fueled HPAPI solutions for:

Cytotoxic Drugs: Toxic compounds used in cancer treatments.
HPAPIs: Up to Band 4.
Peptides & Steroids: Biologic and synthetic compounds.
Hormones: Both male and female.
DEA Controlled Substances: Schedules I-V, L1.

Fully PPE-covered Pii scientist working on HPAPIs in a biosafety fume hood.

Quality from Lab to Launch: HPAPI CDMO Solutions

Our specialized HPAPI CDMO solutions emphasize safety, efficiency, and quality throughout the drug development lifecycle, for a simplified path to market.

Our Quality Assurance

Collect critical OEL data early to ensure safety from day one.

Develop risk management to avoid delays down the road.

Secure safety with top-notch containment and handling protocol.

Careful execution from R&D to commercial production.

30+

years of experience in complex formulations

300+

scientists and support staff

90%

of clients agree we delivered effective solutions

Safety First, Last, & Always

Proactive risk assessments and safety measures ensure the well-being of both people and HPAPI products.

Proactive Risk Management: Thorough safety evaluations from day one.
Leading-Edge Containment: State-of-the-art systems to protect personnel and products.
Ongoing Monitoring: Vigilant oversight at every stage of development.
Compliance-Ready: Meets global safety standards to ensure regulatory success.

With Pii, safety is built into every process—delivering peace of mind while advancing your product.

Masters of Potency

Our HPAPI team combines decades of experience with a true passion for working with potent compounds. We understand the unique challenges that highly potent materials present, from formulation to safety.

Our team brings specialized knowledge in containment, risk mitigation, and regulatory compliance, offering tailored solutions that protect both personnel and product integrity. With a focus on precision and efficiency, we help navigate the complexities of potent pharmaceutical development.