Be Clinic Ready

Early-Stage Development Concept to Clinic

Pii has the agility and internal capabilities to tackle your pre-formulation challenges, support early-phase clinicals, and accelerate early-stage timelines.

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 have a range of flexible formulation solutions to improve the solubility and permeability of your BCS Class drug. We will screen these formulations and work to understand the properties of your compound to determine where the biggest impact can be made.

Pii is proud to offer its pharma partners:

  • Flexible solutions to improving dissolution rate through formulation design and screening
  • Multiple formulation options 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
Solubility and Bioavailability Enhancement

Contact a Pii Scientist to Learn More

Manufacturing Highly Viscous Formulations

Manufacturing Highly Viscous Formulations

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

Pii is uniquely positioned to handle:

RELENTLESS COMMITMENT TO
OPTIMIZED PRODUCT DEVELOPMENT

Lyophilization Cycle Development

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
  • Studying the thermal characteristics of the product and processes
  • Scaling up for GMP manufacturing

 

View Our Lyophilization Cycle Video 

Lyophilization Cycle Development_

Contact a Pii Scientist to Learn More

APPROPRIATE FORMULATION CANDIDATE
SELECTION FOR PHASE I STUDIES

HPAPI

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

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 for DEA Schedule I to V, offering:

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

Talk to a Pii Project Ambassador