HPAPI Manufacturing: Low dose applications

Low dose requirements and the safe handling of highly potent compounds are key challenges in the development and manufacture of many drug products. Contained micro-dosing is often required for accurate dosing and safe drug development. HPAPI manufacturing is one of our core focus areas and we provide fully integrated services from drug substance to sterile fill / finish and specialized oral solid dosage forms inclusive of micro-dosed powder-in-capsule (PIC) or powder-in-bottle (PIB) formats.

Highly potent compounds (HPAPI) are an increasing component of today’s drug development pipeline driven by more targeted therapies and expanded oncology research. These compounds present safety challenges at all stages of development and manufacturing, and require specialized processing and protocols for the drug substances, particle engineering and finished dosage forms. We have premier experience, track record and capabilities for all aspects of contained processing:

  • HPAPI product development, clinical production, and commercial production
  • Micronization / jet milling and spray drying
  • API Powder Encapsulation
  • Parenteral drug development and sterile fill / finish
Antibody-drug conjugates (ADCs), which use antibodies to send cancer-killing molecules directly where they are needed, are one area of focus for oncology researchers. ADCs combine the potency of small molecules (highly potent APIs, or HPAPI) with the selectivity of cancer-specific antibodies.

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Innovations in HPAPI and Antibody-Drug Conjugates Drug Development

Lonza’s HPAPI Manufacturing Advantage

State-of-the art containment and isolation procedures are in place throughout our development and manufacturing network, accommodating end-to-end solutions from HPAPI manufacturing to drug product.

Our Bend OR, Quakertown PA and Monteggio CH sites have leading commercial capacity for manufacturing HPAPI drug product intermediates based on particle size reduction or spray drying technologies. Our Stein, CH and Basel, CH facilities provide parenteral product development and sterile fill / finish services for non-oral applications. Our PIC and PIB drug products are produced at our Tampa FL site, with both non-GMP development and GMP manufacturing encapsulation and bottle-fill capabilities.

Our solid oral drug product technologies, which are based on either liquid-filled hard capsules, improving product dose uniformity facilitated by highly accurate liquid fill metering, minimizing product cross-contamination, increasing operator safety through reducing potential exposure, reducing processing time and costs, increasing fill speeds, removing the risk of fire or explosion due to dusting and improving the overall ease of handling.

We utilize flexible high containment handling capability and facilities for a wide range of compound types and safety classifications, ranging from biologics and small molecules to oral to inhalation and parenteral delivery routes. We can typically accommodate HPAPIs to OEB5. Our co-located product development and manufacturing sites are also equipped to handle other challenging compounds, including controlled substances, hormones and cytotoxics.

Our broad capabilities and integrated approach enable you to use one partner throughout your project, from development through to manufacturing. This reduces risk, complexity, and time to bring your HPAPI product to market.

Our facilities have phase-appropriate processing equipment in place, allowing us to deliver services tailored to the development stage of your HPAPI project. 

We provide integrated HPAPI services across drug substance, particle-engineered drug product intermediates, and specialized encapsulated drug products.

related content

Highly Potent Active Pharmaceutical Ingredients (HPAPIs)
Tech brief
Mini-Monoplant Technology for Pharmaceutical Manufacturing
Peer-reviewed publication
Precision Powder-In-Capsule Micro-Dosing Accelerates Drug Product Development
Executive summary
The Rise of HPAPI Molecules: Trends in Highly Potent API Manufacturing