Featured Articles

31. How A CDMO Achieves Finished Product Lyophilization With Limited And Expensive API 6/27/2022

    Agile, cost-effective lyophilization services can accelerate the development of complex drug candidates that present stability challenges, but lyophilization can be challenging, expensive, and time-consuming.

32. Accelerate The Start Of Your Outsourced Pharmaceutical Project

    In Part 1 of this series, we explore the best way to streamline the initial stages of forging a relationship between the drug maker and a contract development & manufacturing organization (CDMO).

33. 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.

34. The Value Of Orphan Drug Designation

    More than 90% of rare diseases still have no FDA-approved treatment, even though rare diseases affect more than 25 million Americans. Despite the opportunities in the orphan drug market, there are challenges that may act as barriers to entry.

35. Creating A New Dosage Form From An Approved Drug For A New Rare Disease Indication 7/22/2020

    Cure HHT, a foundation representing patients suffering from Hereditary Hemorrhagic Telangiectasia, a genetic blood vessel disorder that causes bleeding in multiple organs, needed assistance in developing a formulation and filing an Investigational New Drug (IND) application with the FDA.

36. Accelerating The Start Of Your Outsourced Pharmaceutical Project: Role Of The Project Technical Review -- Part 2

    Part 2 in this series focuses on the gap between project tech review and the assessing a potential CDMO's capabilities and anticipated project timing to determine necessary resources and outline deliverables.

37. Parenteral Drug Manufacturing — Innovation Begins With A Problem 6/11/2020

    Developing manufacturing processes for complex parenteral drug formulations often presents some of the most challenging problems—and innovative solutions —pharmaceutical scientists and engineers face.

38. Meet A Project Ambassador - Michelle Ava

    Michelle has dedicated her career to simplifying organizational processes, making jobs easier and more efficient. Using a system of her own design, she mines data for relevant material to turn into reliable, actionable information to support executive team decision-making.

39. 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.

40. Client Oriented Project Management 8/5/2020

    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.