ABOUT PHARMACEUTICS INTERNATIONAL
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.
Parenteral Drug Manufacturing — Innovation Begins With A Problem
Developing manufacturing processes for complex parenteral drug formulations often presents some of the most challenging problems pharmaceutical scientists and engineers face and can lead to the most interesting innovative solutions. Effectively employing the three problem-solving essentials—experience, reasoning, creativity—can be the catalyst for success.
Complex Parenteral Drug Manufacturing — A Foundation For Success
Developing and manufacturing complex parenteral drugs is one of the most difficult processes in the pharmaceutical industry. Successful drug manufacturing is built on a solid foundation of skilled professionals, quality systems, and comprehensive risk management.
Optimizing Filling Technology To Minimize API Loss
New advances in filling technology offer solutions that can minimize lost API and eliminate sources of risk while still meeting the regulatory requirements for testing and quality assurance.
Managing The Challenges Of Small Batch Formulations
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.
Overcoming Bioavailability Challenges In Oral Formulation Development
With nearly 90% of developmental pipeline drugs consisting of poorly soluble molecules, formulation experts must address this obstacle by applying approaches to improve an API’s pharmacokinetics.
Managing Risks With Potent Pharmaceutical Products
Managing the risks associated with potent compounds requires a knowledgeable team as well as the design and implementation of an effective safety program.
Is Your Partner Prepared For Your Scale-Up Challenges?
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.
Manage Risks In Development And Manufacture Of Potent Pharma Products
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.
VIDEOS AND WEBINARS
Pharmaceutics International Aseptic Fill Services
First to the market is always key in the pharma industry. Right first time is also a key slogan heard often in the pharma industry as well. With the creative sterile filling solutions that we have to offer, you can learn how Pii, a quick to act and your very own personalized CDMO can help bring your concept to clinic in a nimble and fashion, right first time.
Sterile Filling Challenges For Early-Phase Product Development
Getting your product to the clinic fast is always a key driver in pharmaceutical product development. Producing it right the first time is another key driver. In this webcast, Pii will discuss options for delivering on both of these critical requirements and will talk about the challenges clients have in producing efficient and flexible sterile product filling solutions.