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FREE eBOOK: The Lyophilization Drug Development

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 * About
   * Executive Leadership
   * Business Development Team
   * Subject Matter Experts
   * Career
   * Trade Shows
 * Resources
   * Guide to Aseptic Manufacturing
   * Guide to Oral Drug Manufacturing
   * Articles
   * Blogs
   * Brochures
   * Case Studies
   * Trade Shows
   * eBooks
   * Meet the Scientists
   * Press Releases
   * Videos
 * COVID-19
 * Contact

Search
 * About
   * Executive Leadership
   * Business Development Team
   * Subject Matter Experts
   * Career
   * Trade Shows
 * Resources
   * Guide to Aseptic Manufacturing
   * Guide to Oral Drug Manufacturing
   * Articles
   * Blogs
   * Brochures
   * Case Studies
   * Trade Shows
   * eBooks
   * Meet the Scientists
   * Press Releases
   * Videos
 * COVID-19
 * Contact
 * Formulation & Process Development
   * Oral Drug Development
     * Oral Dose Resource Center
     * Soft Gel Capsules
   * Parenteral Drug Development
     * Aseptic Glass Alternative
     * Aseptic Manufacturing Resource Center
     * 3mL cartridge
     * Aseptic Manufacturing Services
     * Aseptic Manufacturing FAQs
     * Lyophilized Drugs, Proteins and Biologics
     * Highly Potent Manufacturing
 * Contract Analytical Services
 * Tech Transfer & Manufacturing
   * Commercial Manufacturing
     * Serialization
     * Vaccine Fill-Finish Tech Transfer
   * Clinical Trial Manufacturing
 * Enhanced Services
   * Quality Assurance
   * Project Management

 * Formulation & Process Development
   * Oral Drug Development
   * Oral Dose Resource Center
   * Soft Gel Capsules
   * Parenteral Drug Development
   * Aseptic Glass Alternative
   * Aseptic Manufacturing Resource Center
   * 3mL cartridge
   * Aseptic Manufacturing Services
   * Aseptic Manufacturing FAQs
   * Lyophilized Drugs, Proteins and Biologics
   * Highly Potent Manufacturing
 * Contract Analytical Services
 * Tech Transfer & Manufacturing
   * Commercial Manufacturing
   * Serialization
   * Vaccine Fill-Finish Tech Transfer
   * Clinical Trial Manufacturing
 * Enhanced Services
   * Quality Assurance
   * Project Management


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
requirement, and accelerate early-stage timelines so you can stay on budget and
on schedule.

Contact Us



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 range of technologies and
equipment to support your formulation development and clinical trial
manufacturing.



View Oral Dose Soft Gel Video

View Our Lyophilization Cycle Video

View Clinical Aseptic Filling Video

View Pre-Filled Syringe Video

View Small Scale Aseptic Fill-Finish Video

View our Aseptic eBook



Solubility and Bioavailability Enhancement/Parenteral and Oral Dose (solid and
liquid)

Lyophilization Cycle Development

HPAPI, Hormones, and Controlled Substances, such as DEA Schedule I-V Drugs

Highly Viscous Formulations-Drug Development





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 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

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 translate 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 R&D team working hand in hand with
   production team members to transfer formulations and processes

 

View Our Lyophilization Cycle Video 




CONTACT A PII SCIENTIST TO LEARN MORE

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

Whether 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 4,000cP)
 * 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

NEW! Pii now offers Stand-Alone Contract Analytical Services!

Pii’s full-service analytical team can assist you with to take your project from
Concept-to-Clinic-to-Commercialization with our Pharmaceutics Know-How™.




TALK TO A PII PROJECT AMBASSADOR

Contact


PHARMACEUTICS INTERNATIONAL, INC

 * Formulation & Process Development
   * Oral Drug Development
     * Oral Dose Resource Center
     * Soft Gel Capsules
   * Parenteral Drug Development
     * Aseptic Glass Alternative
     * Aseptic Manufacturing Resource Center
     * 3mL cartridge
     * Aseptic Manufacturing Services
     * Aseptic Manufacturing FAQs
     * Lyophilized Drugs, Proteins and Biologics
     * Highly Potent Manufacturing

 * Contract Analytical Services

 * Enhanced Services
   * Quality Assurance
   * Project Management

 * Tech Transfer & Manufacturing
   * Commercial Manufacturing
     * Serialization
     * Vaccine Fill-Finish Tech Transfer
   * Clinical Trial Manufacturing

 * About Us
   * Executive Leadership
   * Business Development Team
   * Subject Matter Experts
   * Career
   * Trade Shows

 * Privacy Policy
 * Terms of Use
 * Site map


FOLLOW US




CONTACT US

Call Pii: 410.584.0001
Email Pii




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