Drug Formulation & Process Development
Trust your drug and biologic formulation development with Pii’s proven experts, who have the knowledge and experience to deliver your dosage form. Pii supports a full range of parenteral and oral dose forms for every stage of clinical development through commercialization, utilizing QbD principles.
DRUG LYO FORMULATION EXPERTISE
Developing an effective lyophilization cycle is both an art and a science. Pii’s skilled, experienced team of professionals utilizes Millrock lyophilization technology, which provides development lyo cycles that translate from lab to production. This ensures quality with minimal delays from concept to commercialization.
From Concept to Clinic to Commercialization
Pii is a U.S.-based CDMO, operating more than 300,000 square feet of state-of-the-art pharmaceutical development and manufacturing space – all located on one campus in Hunt Valley, MD. Our facilities are GMP inspected, DEA licensed I-V, and include a dedicated formulation development center for oral and sterile products. With over 70 flexible manufacturing suites, including containment areas for handling potent compounds HPAPI (up to SafeBridge® Category 4) and hormones, Pii has the depth to support formulation development, utilizing QbD, clinical and commercial requirements for your products at every stage of your 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 know how 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
- Addressing drug delivery with required pharmacokinetics (PK)
- Improving organoleptics and posology
- Achieving long-acting, depot, modified, sustained, pulsatile and controlled release
- Developing lyophilization cycles
Potent Compounds
Each high potent active pharmaceutical ingredient (HPAPI) project is complex and unique. Many HPAPI manufacturing processes involve new chemical entities (NCEs) with limited toxicity data. Pii’s experience assessing and developing safety protocols for NCEs and NBEs is a clear asset in supporting the development and production of these compounds in a safe environment.
Pii’s 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, L1
- Pii is DEA-registered for DEA-Controlled Substances (Schedule I-V, L1).
- Pii handles the paperwork and any necessary quotas for your product.
- Pii has DEA-compliant storage, including cages and vaults at various storage temperatures to meet your product requirements.
Hormones
Pii has more than 25 years of experience in formulating and manufacturing hormone-containing products.
Separate manufacturing suites with dedicated air handling systems are engineered to accommodate hormone-containing products.
Our capacity to implement specialized containment and single-use disposable technologies enables us to help you with your hormone compound.
Our capabilities to manufacture and package clinical and commercial hormone-containing products include:
- Oral contraceptives
- Hormone replacement therapies
- Oncology hormonal-based products
Bioavailability Enhancement
More than 80% of today’s NCEs suffer from low solubility, permeability — or both — resulting in limited or poor bioavailability.
Pii can help support these bioavailability challenges by formulating to enhance 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 granulation 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
Pii has the depth of knowledge and proven technical experience to solve difficult-to-formulate challenges while also meeting the requirements to complete your CMC package.
We present customer partners 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 that exhibit 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. For poorly soluble compounds, Pii offers a variety of bioavailability enhancement technologies, including solid dispersion development and lipid or macro-/nano-based emulsions.
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Learn More About Our Aseptic Filling Capabilities
Concept to 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)*
- Characterizing and selecting the best formulation and dose form candidates for the next steps in development
- Manufacturing GMP clinical trial batches
- Providing analytical services, methods development, validation, and stability programs
- Generating 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 Pharmaceutics Know-How™.
*Screening and selection of different dosage forms
