Pii - Drug Development and Delivery

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.