Drug Formulation
Know-How

Trust your drug and biologic formulation development with our proven experts that have the experience and Know-How™. Pii provides a full range of parenteral and oral dosage forms at every stage of clinical development and commercialization utilizing QbD principles.

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SOLUTIONS AT EVERY STAGE OF YOUR DRUG DEVELOPMENT

From Concept to Clinic to Commercialization

Pii is a U.S.-based CDMO and operates over 360,000 square feet of state-of-the-art pharmaceutical development and manufacturing space, all located on one campus in Hunt Valley, MD. Our facilities are cGMP inspected and include a dedicated formulation development center for oral and sterile products. With over 70 flexible manufacturing suites, several include containment controls for handling potent compounds HPAPI (up to SafeBridge® Category 4) and hormones, as well as licensed to manufacture DEA Schedule I-V products. Pii has the depth to support the development utilizing QbD, clinical and commercial requirements for your products at every stage of drug development.

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Formulation Capabilities

The Pii formulation team consists of experienced and proven formulators and chemists who understand what it takes to meet the requirements of your Target Product Profile (TPP). At Pii, we have “walked in your shoes” for over 25 years and understand what it takes to navigate the technical and regulatory landscape to accelerate your decision-making. Our team will provide experience-based insight, guidance and support across the following areas for oral or parenteral drug delivery:

  • Solubilizing water-insoluble drugs and enhancing bioavailability
  • Stabilizing sensitive molecules
  • Drug Delivery with required pharmacokinetics (PK)
  • Improved organoleptics and posology
  • Achieving long-acting, depot, modified, sustained, pulsatile and controlled release
  • Lyophilization cycle development

Potent Compounds

Each high potent active pharmaceutical ingredient (HPAPI) project is complex and unique. Many HPAPI manufacturing processes involve new chemical entities (NCEs) without toxicity data. Pii’s experience assessing and developing safety protocols for NCEs and NBEs, is a clear asset in the pre-formulation and product development process.

Pii dedicated facilities are designed with single-pass air flow systems, including vestibules, airlocks, closed restricted air barrier systems (RABS), and pressure and filtration equipment. Facilities can accommodate highly potent drugs for any active up to SafeBridge® Category 4.

Pii has the capacity to implement specialized containment and single-use disposable technologies that enable us to safely work with your potent compound.

DEA Schedule I-V

  • Pii is DEA-registered for Schedule I-V drugs.
  • Pii handles the paperwork and quotas for your product.
  • Pii has DEA compliant storage including cages and vaults at storage temperatures to meet your product requirements.

Hormones

  • 20 years of experience formulating and manufacturing hormone-containing products.
  • Extensive capability to manufacture and package clinical and commercial hormone-containing products including:
    • Oral contraceptives
    • Hormone replacement therapies
    • Oncology hormonal-based products

Pii has separate manufacturing suites with dedicated air handling systems to accommodate hormone-containing products.

Pii has the capacity to implement specialized containment and single-use disposable technologies that enable us to help you with your hormone compound.

Bioavailability Enhancement

Over 80% of NCEs suffer from low solubility, permeability or both and the resulting poor bioavailability.

Pii can help you with your bioavailability challenges of enhancing the absorption of your BCS II, III and IV compounds.

The specialized dosage forms we develop and manufacture to meet the challenges of poor bioavailability are:

  • Stabilized amorphous formulations (e.g. hot melt extrusion and spray dried dispersions)
  • Complex solubilization systems (e.g. cyclodextrins and lipids SEDDS, SMEDDS)
  • Nanopowders and dispersions (e.g. particle engineering)

Pii’s diverse technological capabilities and proven experience accelerate decision-making at every step in the development process.

Formulation Development

We have the depth of knowledge and proven technical experience to solve problems and work with the FDA to get your molecule or biologic from concept to clinic.

Pii presents clients with a full range of options to develop small molecules into effective pharmaceutical products. Pii’s highly trained scientific team has extensive experience working with a variety of drug substances with a range of physicochemical characteristics.

From first-in-human studies to commercial launch, Pii will work with you to determine the most efficient and viable pathway for your compound. Pii’s development capabilities include controlled-release formulations. For poorly soluble compounds, Pii offers a variety of bioavailability enhancement technologies, including solid dispersion development, and lipid-or macro/nano-based emulsions.

Our Aseptic Filling Know-How

Concept to Clinic Know-How for Phase I Clinical Trials

Pii will map out and lead you down the fastest path to filing the IND application for your molecule or biologic. We understand your need to do more with less and move faster than ever before. Whether your constraint is time, budget, or amount of API, Pii will design, execute and lead a development program customized to meet your goals. A major barrier to the advancement of many NCEs into Phase I is their poor solubility. To address these difficult-to-formulate compounds, Pii offers a comprehensive portfolio of drug-delivery solutions.

Our development and supply services include:

  • Developing early phase fit-for-purpose formulations (e.g. increase solubility and stability)
    *Screening and selection of different dosage forms
  • Characterizing and selecting the best formulation and dose form candidates for next steps in development
  • Manufacturing cGMP clinical trial batches
  • Providing analytical services, methods development, validation and stability programs
  • Generate data required for IND filings and FDA meetings (e.g. pre-IND and pre-NDA)
  • Pii will accelerate your decision-making and progress from molecule and biologic sourcing to pre-formulation and clinical trial supply using our Concept to Clinic Know-How™.

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