Be Clinic Ready
Early-Stage Development from Concept to Clinic
Pii has the agility, internal capacity, and capabilities to tackle your pre-formulation and formulation challenges, support early-phase clinical dose requirements, and accelerate early-stage timelines so you can stay on budget and on schedule.
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 an experienced scientific team and a range of technologies and equipment to support your formulation development and clinical trial manufacturing.
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
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, 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
Contact a Pii Scientist to Learn More
APPROPRIATE FORMULATION CANDIDATE
SELECTION FOR PHASE I STUDIES
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:
- The ability to handle highly potent compounds, hormones, and cytotoxics for oral and injectable drug products
- Single-use disposable systems
- 15 containment suites
- EU and FDA compliance for shared-use facilities
- Proactive risk management for each drug substance/product that is introduced into our facilities
- Engineering and facility design for prevention of cross-contamination and ensuring safe handling
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
Pii is uniquely positioned to handle:
- Injectable formulations (up to 4,000cP)
- Soft gel and oral suspension formulations
- Lipid formulations
- Full analytical and micro support for challenging controlled release or depot method development/validation and testing, including dissolution apparatus IV
Pii’s full-service analytical team can assist you with your project from Concept-to-Clinic-to-Commercialization with our Pharmaceutics Know-How™.