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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. Liquid and semi-solid fill technologies are proven oral solid dosing approaches for achieving dose content uniformity and offer safety benefits versus solid powder encapsulation or tableting options. HPAPI 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 liquid-filled hard capsules or soft gels.

Highly potent compounds 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
  • Lipid / liquid-based formulations
  • 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 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 to drug product.

Our Bend OR, Quakertown PA and Monteggio CH sites have leading commercial capacity for producing 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 solid oral drug product technologies, which are based on either liquid-filled hard capsules or soft gelatin capsules, offer a number of advantages over tablets or solid-fill capsules, including:

  • 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
  • Improving the overall ease of handling

We provide clinical and commercial drug product manufacture utilized liquid, semi-solid and solid encapsulation at our Edinburgh UK, Ploermel FR and Tampa FL sites.

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. 

Technologies and products

service
HPAPI Product Handling
HPAPI product development and manufacturing is core to Lonza. Learn about our industry-leading capabilities for HPAPI from concept to commercialization.
service
Small Molecule Parenteral Formulation Development
Our Drug Product Services team (Lonza DPS) offers a smart approach that considers the interplay between solubility, local tolerance and systemic toxicity for rapid and successful development of your parenteral small molecule program.
service
Small Molecule Parenteral Manufacturing
Our Drug Product Services (Lonza DPS) team manufactures GMP liquid and lyophilized parenteral small molecule drug product batches for clinical and commercial supplies, as well as non-GMP batches for toxicological and stability studies, in addition to refe...
technology
Liquid-Filled Hard Capsule Technology
Liquid-filled hard capsule technology has a proven track record in addressing a range of complex formulation challenges inclusive of solubility/bioavailability and low dose/highly potent issues. We provide integrated services for LFHC development and manu...
technology
Micro-dosing for Powder-in-Capsule / Powder-in-Bottle Studies
Micro-dosing for powder-in-capsule / bottle evaluations can accelerate your phase I and II studies. Learn more about Lonza's micro-dosing and other rapid development tools.
technology
Soft Gelatin Capsules
Softgels provide an important dosage technology that can be highly beneficial in addressing a wide array of formulation challenges, such as bioavailability enhancement and low dose/HPAPI applications including hormones.
We provide integrated HPAPI services across drug substance, particle-engineered drug product intermediates, and specialized encapsulated drug products.

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The Rise of HPAPI Molecules: Trends in Highly Potent API Manufacturing
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