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.
Applying The Four Dimensions Of Sustainability To Create Capacity That Delivers Results Faster
There are no shortcuts to growing capacity that delivers results faster and maintaining it is difficult. The key ingredient in growing enterprise value is sustainability. Learn how by applying the principle of sustainability using its four dimensions, finite resources are more wisely used with extraordinary results, lead time from concept to commercialization is greatly improved, and patients receive better medications faster.
Phase-Appropriate Drug Development – Validation Process
The drug development process is among the most complex, costly, and regulated of human pursuits and the statistical chances of success are horribly low. However when we couple new trends in patient disease knowledge with a disciplined phase-appropriate process for drug development, a more cost effective, success-oriented model emerges. Let’s consider phase-appropriate development by applying it to process validation.
Supply Chain Transformation, 503B And Reducing Drug Shortages
Currently there are two great forces at work that are disrupting traditional models for advancing drug therapies from discovery to commercial production and distribution. This transformation, when complete, will impact the biopharmaceutical supply chain significantly and potentially achieve outcomes that were considered impossible a short time ago.
Client Oriented Project Management
With the significant amount of outsourcing being done by the pharmaceutical industry, we believe project management has earned the right to be a critical factor in CDMO selection and deserves some exploration and understanding. Over our 26-year history and having successfully completed over 400 development projects, Pii has developed and refined project management operations to ensure outcomes are achieved and client expectations are exceeded. We have found that excellent project management has seven distinct features.
Preventing Cross-Contamination – Operating Beyond cGMP
Conditions driving modern pharmaceutical development and manufacturing have increased the risk of cross-contamination. This blog shares best practices from a CDMO for preventing cross-contamination.
Creating A New Dosage Form From An Approved Drug For A New Rare Disease Indication
Armed with a promising idea and an urgency to help patients with Hereditary Hemorrhagic Telangiectasia, Cure HHT contacted Pii for assistance in developing a formulation and filing an Investigational New Drug (IND) application with FDA. The formulation, analytical and regulatory teams at Pii worked with a unity of effort and filed the IND fourteen days after starting the project.
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.