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.
Pii offers phase-appropriate development
in early stages to accelerate timelines
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 a range of special equipment to support your 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 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, utilizing technologies like nanoparticles and spray-drying.
Pii is proud to offer its pharma partners Solubility and Bioavailability Enhancement:
- 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
Contact a Pii Scientist to Learn More
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
- Studying the thermal characteristics of the product and processes
- Scaling up for GMP manufacturing
Contact a Pii Scientist to Learn More
APPROPRIATE FORMULATION CANDIDATE
SELECTION FOR PHASE I STUDIES
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:
- The ability to handle highly potent compounds, hormones, and cytotoxics for oral and injectable drug products
- Single-use disposable systems
- 10 containment suites
- EU and FDA compliance for shared-use facilities
- Proactive risk management
- Engineering and facility design
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
Manufacturing Highly Viscous Formulations
Whether it’s 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:
- Injectable formulations (up to 4,000 cP)
- Soft gel and oral suspension formulations
- Lipid formulations
