Phase-appropriate CDMO solutions

Empowering Your Drug Development Journey

Pii offers customized drug development solutions, specializing in analytical, development, and manufacturing services, providing our clients with the custom-tailored solutions for the next phase of their development journey.

Our solutions team works with you to overcome obstacles and achieve your mission of improving patient outcomes. Whether you need aseptic fill finish or oral solid dose manufacturing, we have the drug product solutions for a reliable supply for your clinical or commercial needs.

Pii is with you every phase of the way

Clinical Trial Manufacturing

Accelerate your drug (NCE) or biologic (NBE) from Preclinical through Commercial Supply, utilizing QbD principles that overcome development challenges and reduce costs. Pii has an experienced scientific team and a range of technologies and equipment to support your formulation development and clinical trial manufacturing.

Solubility/Bioavailability Enhancement

Ninety percent of new oral solid drugs are poorly soluble. Pii has extensive scientific experience across a range of molecules, including BCS Class II to IV drugs. We offer flexible formulation solutions to improve the solubility and permeability of your challenging drugs. Pii will work to understand the physicochemical properties of your drug and will utilize excipient and formulation screening processes to determine where the biggest impact can be made, utilizing technologies like solid dispersions and SMEDDS, nanoparticles, wet milling, inclusion complexes and spray-drying.

Pii is proud to offer our pharmaceutical and biotech partners options for Solubility and Bioavailability Enhancement:

  • Flexible solutions to improving dissolution rate through formulation design and screening
  • Multiple formulation techniques that can be scaled to manufacturing for early-phase toxicity studies or clinical supplies
  • Seamless formulation development to Phase I manufacturing by tailoring the design of formulation and dosage form to the physicochemical characteristics of the compound, saving time and minimizing use of the API, keeping you on schedule and on budget
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RELENTLESS COMMITMENT TO
OPTIMIZED PRODUCT DEVELOPMENT

Lyophilization Cycle Development
Vial Sizes from 3 mL to 50 mL

During the development of the lyophilization cycle or when optimizing a known lyophilization cycle, the understanding of thermal and physical characteristics is essential, as no two products are alike.

Pii’s expertise in lyophilization formulation, cycle development, cycle and process optimization, and process knowledge will de-risk the product development process by:

  • Conducting experiments at an R&D scale, which easily translates to larger GMP production equipment
  • Studying the thermal characteristics of the product and processes to minimize issues in later stage production
  • Scaling up for GMP manufacturing, with the R&D team working hand in hand with production team members to transfer formulations and processes

 

View Our Lyophilization Cycle Video 

Lyophilization Cycle Development

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APPROPRIATE FORMULATION CANDIDATE
SELECTION FOR PHASE I STUDIES

HPAPI

High-Potency Active Pharmaceutical Ingredients (HPAPI)/DEA Scheduled Drugs/Hormones

The number of drug products that contain highly potent APIs has been steadily increasing for the past decade. These hazardous materials have special handling and containment requirements for developing and manufacturing.

Pii is one of the few CDMOs with:

 

Pii is also licensed and experienced in handling DEA Schedule I-V Drugs, offering:

  • Oral and injectable product development and manufacturing
  • In-house DEA refrigerated/frozen storage for development projects
  • Experience with management of inventories and quota applications for both development and commercial products

Manufacturing Highly Viscous Formulations

Whether biologics, such as monoclonal antibodies (mAbs), formulations that require sustained or controlled release, or non-aqueous formulations, each presents manufacturing challenges.

Pii is uniquely positioned to handle:

NEW! Pii now offers Stand-Alone Contract Analytical Services!

Pii’s full-service analytical team can assist you with your project from Concept-to-Clinic-to-Commercialization with our Pharmaceutics Know-How™.

Manufacturing Highly Viscous Formulations

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