Featured Articles

31. Self-Injection Of Biologics Made Easy 6/17/2022

    Ready-to-Use (RTU) 3mL cartridge-based, single-use Pen Devices are specifically designed to ensure consistency of delivery for high-volume, high-viscosity injectable drug delivery systems.

32. Complex Parenteral Drug Manufacturing — A Foundation For Success 6/11/2020

    A first-hand account of what it takes to develop and manufacture complex parenteral drugs.

33. Meet The Scientist — Sam Chia

    Sam is responsible for the sterile injectables facility, including four manufacturing suites and housing R&D, quality control, microbiology, and engineering support. He believes his role is most importantly about people – his colleagues and the patients who rely on the drug therapies they develop and manufacture.

34. 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.

35. 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.

36. Drug Repurposing Advantages And Strategies

    Identifying new therapeutic uses for old, existing, or available drugs is an effective strategy in discovering or developing drug molecules with new pharmacological and therapeutic indications.

37. 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.

38. 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.

39. Artful Taste Masking Improves Patient Compliance 5/12/2022

    Taste masking is required for dosage forms that interact with the taste buds. Discover some of the best and most practical taste masking methods to consider for each API.

40. Demystifying Highly Potent API And Cytotoxic Drug Products

    The concept of development, process design, and manufacturing of drugs with a HPAPI or cytotoxic compounds should not be a mystery to drug sponsors using a CDMO. 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.