Pharmaceutics International, Inc. (Pii)
10819 Gilroy Road
Hunt Valley, MD 21031
T: (410) 584-0001
E: bd@pharm-int.com or pdupont@pharm-int.com
W: www.pharm-int.com

Year Founded: 1994
Number of Employees: 350
Key Personnel: Dr. Kurt Nielsen, President & CEO
Business Development Team: PJ Kim, Head of Commercial and Corporate Development, Kevin Kelly, Head of Sales and Brian Sasaki, Senior Director of Business Development
Marketing: Paul Dupont, Head of Digital Marketing and Devan Patel, Senior Director of Business Development

 

Concept to Clinic to Commercialization

At Pharmaceutics International, Inc. (Pii), our motto is “challenges frame opportunities.” We are a US-based contract development and manufacturing organization (CDMO) that has “walked in your shoes” and has a passion for solving problems efficiently with the highest quality standards. Emphasizing a collaborative relationship with our clients, Pii’s experts embrace the art and science of drug development and manufacturing. Our outcome is to deliver better results faster for our clients and their patients.

Pii’s Hunt Valley, Maryland campus includes four cGMP and FDA certified facilities, 70 manufacturing suites with all the necessary analytical testing capabilities on site, and four integrated aseptic filling suites delivering quality, safety, and efficiency.

Experienced with small and large molecule compounds, we have special expertise in developing and manufacturing complex parenteral drugs, vaccines, extended-release formulations, and non-aqueous injectable drug products. We can also overcome stability challenges with precision lyophilization cycle development and production.

 Services

  • Formulation and Process Development
  • Oral Drug Development
  • Parenteral Drug Development
  • Bioavailability Enhancements
  • Method Development and Validation
  • Stability Testing
  • Clinical Trial Manufacturing
  • Commercial Manufacturing
  • Highly Potent Drug Manufacturing
  • Analytical Services
  • Regulatory Support
  • Quality Systems Development

Capabilities 

  • Development and Commercial Technology Transfer
  • Vaccine Fill/Finish
  • Steriles-vials, syringes, cartridges
  • Lyophilization
  • Highly Potent Compounds — hormones, cytotoxins
  • Parenterals — aqueous, non-aqueous
  • Oral Solids — softgels, tablets, capsules
  • Oral Liquids — suspensions, syrups, solutions
  • Solid dispersions
  • Topicals
  • Controlled release formulations
  • Fluid-bed processing
  • Micro and nanotechnologies
  • Coating
  • Packaging Serialization
  • Enhanced Project Management

 

The Complete Guide to Aseptic Manufacturing — Ebook Download
The aseptic manufacturing process is complex with each drug candidate’s unique set of challenges. Speed to market is necessary, it’s crucial to follow a strong quality risk management, operate in a current cGMP environment with vigilant personnel practices. Pii has created a useful E-BOOK from Pii that provides a Complete Guide for Aseptic Manufacturing


STERILE FILL-FINISH

Complex Parenteral Drug Manufacturing — A Foundation for Success

The Art & Science of Tech Transfer – Transferring Vaccine Production

The Art & Science of Tech Transfer – Establishing the Path for Success

Parenteral Drug Manufacturing — Innovation Begins With a Problem

Demystifying Highly Potent API & Cytotoxic Drug Products

There’s No Place Like Home: The Case for Repatriating the Pharmaceutical Supply Chain

Applying Quality by Design to Pharma Research & Development

GENiSYS®R Aseptic Filling & Closure System Video

Enhanced Spray-Drying Capabilities – Press Release

Meet the Scientist Dr. Bryan K. Braxton, PhD

Achieving Agility When Facing Uncertainty — Scaling Aseptic Pharmaceutical Production

Managing the Challenges of Small Batch Formulations

ORAL SOLID DOSE

Overcoming Bioavailability Challenges in Oral Formulation Development

Managing Risks With Potent Pharmaceutical Product

FORMULATION & ANALYTICAL TESTING

Phase Appropriate Drug Development Validation Process

Client Oriented Project Management

Applying the Four Dimensions of Sustainability to Create Capacity That Delivers Results Faster


Click here to learn more about Pii’s integrated phase appropriate CDMO services.

Click here to learn more about our tech transfer services for drug development and commercial.

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Click here to view our resource page with article, case studies, and videos.