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.

 

FEATURED SERVICES

At Pii, quality is the foundation of everything we do. We strive to be a reliable commercial manufacturing and packaging partner by building exceptional quality systems matched by our well-designed facilities, proven technologies, broad expertise, and knowledgeable personnel.

Regardless of where your promising drug product is in the development process, our experienced team at Pii will seamlessly transfer the results of your efforts into our hands and quickly get to work advancing it to the next phase.

Developing an effective lyophilization cycle is both art and science. Our skilled, experienced team of professionals, using Millrock lyophilization technology, provide critical synergies between the development lab and manufacturing line, ensuring your outcomes are met on time with quality.

The stakes are high! 100,000 doses of a modern parenteral drug formulation can cost millions. With patient populations whose lives depend on quality injectables delivered on time, there is simply no room for anything less than perfect.

Our Pharmaceutics Know-How™ accelerates the development of parenteral formulations for clinical trials and improves your decision-making from concept to clinic and commercialization. We have the proven experience, modern equipment and facilities to develop and supply injectable products (IV, IM and SC) and formulations including:

More than 45+ commercial approvals in 25 years of commercial manufacturing service.

Pii has broad knowledge and technical experience in dosage form development and cGMP manufacturing.

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, 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.

CONTACT INFORMATION

Pharmaceutics International

10819 Gilroy Road

Hunt Valley, MD 21031

UNITED STATES

Phone: 410-584-0001

Contact: Michelle Ava

FEATURED ARTICLES

  • Meet The Scientist — Sundeep Sethia, Ph.D.

    When meeting Dr. Sundeep Sethia, one is struck by the sense that they are speaking with someone who is engaged in their work each day, and according to Sundeep, “nothing is more fulfilling.” Sundeep has dedicated his life toward overcoming bioavailability and solubility challenges in the drug development process.

  • Agile, Cost Effective Lyophilization Cycle Development

    Lyophilization can be expensive and time-consuming. Our lyophilization capabilities deliver cost-effectiveness, agility, and superb data-capture, and your lyophilization cycle development will be done by experienced, skilled research and development scientists.

  • Achieving Agility When Facing Uncertainty — Scaling Aseptic Pharmaceutical Production

    This past year has taught us that agile organizations will not only survive, but prosper, when faced with unexpected challenges. Learn the requirements for a framework that assures agility when scaling aseptic drug production.

  • Enhancing Oral Solid Dose Solubility And Bioavailability With Amorphous Solid Dispersions (ASD)

    Spray dried amorphous solid dispersions technology may be the catalyst needed to overcome solubility and bioavailability challenges for your promising oral solid dose candidate. We have the spray drying and auxiliary equipment and skills to rapidly find a solution to develop for formulation, support regulatory filings, and advance your drug candidate to Phase 1 studies and beyond.

  • Meet The Scientist — Bryan Braxton, Ph.D.

    Bryan Braxton has a friendly, grounded demeanor and a scientific mind that creates solutions for our most complex aseptic development projects. But how did these two traits combine in the same person?

  • Innovating During The COVID-19 Pandemic

    Pharmaceutics International, Inc., (Pii) is a premier 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.

  • CDMO Innovation For The Future Pharmaceutical Supply Chain

    We have a longstanding mantra, “challenges frame opportunities,” and this applies to how we intentionally innovate, modernize, introduce new capabilities, and expand capacity.

  • There’s No Place Like Home: The Case For Repatriating The Pharmaceutical Supply Chain

    The pandemic has broadcast a loud call for bringing our nation’s pharmaceutical healthcare supply chain back to the United States. Bringing it home will provide greater regulatory control and patient, economic and workforce benefits.

  • Demystifying Highly Potent API And Cytotoxic Drug Products

    Capturing the right information early demystifies the development process, especially for drugs with HPAPI components. Gathering, organizing, and understanding critical risk data related to HPAPIs and cytotoxic drugs ensures appropriate controls are defined from concept to clinical batch manufacturing to commercial-scale manufacturing. 

  • The Art and Science Of Tech Transfer – Transferring Vaccine Production

    Facilities committed to prioritizing COVID-19 production are forcing non-COVID-19 vaccine makers to shift their production needs to other facilities, requiring a technology transfer in each case. 

  • Applying Quality By Design To Pharmaceutical Research And Development

    QbD is often discussed in the context of process development and manufacturing. We focus on QbD applied to R&D to drive better results throughout the drug development process.

  • Vaccine Capacity Musical Chairs

    In the past six months, I’ve spoken to more vaccine developers than I have in the previous eight years, all of them searching for production capacity. Has the music stopped? Is it time to grab a chair?

  • Art And Science Of Tech Transfer — Establishing The Path For Success

    Pharmaceutical technology transfer often invokes images of a complicated set of activities required to transfer the development and manufacturing of a product, or products, from one facility to another. This article shares five features of a successful tech transfer, imperatives that we have learned with a focus on drug sponsors working with CDMOs. These imperatives, when applied to project management operations, can deliver extraordinary results.

  • Innovative Therapies Supporting 503B Of The Federal Food, Drug, And Cosmetic Act (FD&C Act)

    Innovative therapies including customized, patient-specific compounds, are transforming healthcare, and presenting new challenges for pharmaceutical development, manufacturing, and supply chain management. Our healthcare ecosystem is experiencing tectonic shifts and providing a reliable supply of safe and effective medicines for hospitals and clinics to use for their patients will require an innovative, problem-solving mindset.

  • 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.

VIDEOS AND WEBINARS

  • Sterile Parenteral, Aseptic Fill-Finish, Helping You Take Your Drug from Concept To Clinical To Commercial

    Pii can provide you with the state-of-the-art GENiSYS R aseptic filling and closure system. The GENiSYS R aseptic filling and closure system is a fully robotic, automated line providing accurate precision-filling and eliminating the loss of costly drug product.

  • 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.