Industry Insights

81. Sample Sizes For Performance Testing Of Combination Products, Packaging 5/16/2025

    When developing combination products or evaluating primary packaging for drug products one must evaluate the performance of the devices and the packaging to ensure that they are fit-for-purpose.

82. 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.

83. Solid Form Screening, Rapid Formulation Selection To Meet Tight Timelines

    A comprehensive approach to evaluating drug molecules for the selection of a lead solid form and formulation can significantly accelerate development timelines and limit risks in later development.

84. Can We Eradicate Tech Transfer? 9/23/2020

    While warp-speed manufacturing is a pandemic term, the concept is important to the FDA’s 21st century vision of “a maximally efficient, agile, flexible pharmaceutical manufacturing sector that reliably produces high-quality drugs without extensive oversight.” Reaching 21st century performance requires replacing many 20th century practices.

85. Best Aseptic Practices For The Future Of Cell And Gene Therapies 10/5/2023

    Explore best aseptic practices for cell and gene therapy production that will be foundational to the ongoing development of these therapies as well as their successful manufacturing operations.

86. A Robust Extractables Data Package Helps Drive Patient Safety 10/1/2024

    Complex drug product formulations are more common, so it is imperative to have a deeper knowledge of extractables to understand risks associated with potential interactions between packaging and product.

87. Top 5 Challenges In Antibody-Oligonucleotide Manufacturing 7/10/2026

    AOC manufacturing breaks programs in five predictable ways. Learn where antibody-oligonucleotide conjugate development stalls, from synthesis impurities to conjugation chemistry, and what preparation actually looks like.

88. Your 3-Step Process For Innovation In Precision Medicine 8/3/2022

    Scientific advances are exciting, but not every discovery translates well into the clinic. Why is that? And how can companies successfully position themselves for market success with their drug discovery efforts? 

89. Cleanroom Gowning Compliant With EU GMP Annex 1: An Overview 12/1/2022

    This article focuses on cleanroom gowning as it pertains to aseptic manufacturing of medicinal products and the updates to gowning requirements in the revised EU GMP Annex 1 document published in August 2022.

90. Multicolor Microscopy: The Importance Of Multiplexing 6/8/2023

    Avoid the misleading effects of fluorescent crosstalk during imaging, find out how to select the right combination of fluorophores, and explore other approaches to avoid crosstalk during multiplexing experiments.