Pharmaceutics International, Inc. (Pii) is a premier Contract Development and Manufacturing Organization (CDMO), offering unparalleled scientific insight and depth of product knowledge, while supplying high quality dosage forms that enhance the lives of patients worldwide.
Pii provides customized and flexible solutions, across several dosage forms and has experience with a broad range of compounds. For twenty-five years Pii has been supporting its pharmaceutical partners (from virtual to multinational) with extensive technical capabilities, know-how, and the highest level of customer service. With more than 400 development programs completed, Pii’s scientific team has extensive experience working with drug substances representing a range of physicochemical characteristics (and challenges). Our specialized capabilities, multi-product facilities and knowledge-base, allow us to work with potent compounds and hormones, develop complex dosage forms, and support varied manufacturing processes.
Pii 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. This includes over 70 flexible, manufacturing suites (Class 100 to 100,000), several with the required containment controls for handling potent compounds and hormones, as well as a dedicated suite for the production of soft gel capsules. Licensed to manufacture DEA Schedule I-V products, with capabilities for both oral delivery and parenteral dosage forms, Pii has the depth to support development, clinical and commercial requirements. Facilities are cGMP qualified and include dedicated formulation development centers for solid oral, liquid and sterile products.
Pii can streamline your tech transfer and product development objectives. Pii has added to its capabilities by installing an AST GENiSYS® R, automated cGMP aseptic small batch filling system. The GENiSYS® R system was designed to alleviate development challenges by automating key process and making critical process data readily accessible.
To introduce this cutting-edge technology Pii will offer a credit of $100,000 toward a Phase I – First-in-Man Program.
Learn More http://bit.ly/2WEuydJ
10819 Gilroy Road
Hunt Valley, MD 21031
Contact: Michelle Ava
A risk-based investment in understanding GMP manufacturing at small scales can prevent costly issues during scaling development that ultimately affect the timely delivery to patients in need.
With nearly 90 percent of the developmental pipeline drugs consisting of poorly soluble molecules, formulation experts must be prepared to address this obstacle by applying various approaches to improve an API’s pharmacokinetics.
Managing the risks associated with potent compounds requires a knowledgeable team as well as the design and implementation of an effective safety program.
Most early-stage companies are not equipped with the means necessary for successful scale-up and commercialization, it is critical you find a partner that can help you overcome the challenges.
Given the variety of potent drugs in development, outsourcing the development and manufacturing to a CDMO experienced in handling a range of products, in a multi-use facility, is an effective strategy.