Articles in this Issue
Standard operating procedures, prevalent across pharma Regulatory Affairs, Quality and Pharmacovigilance/Drug Safety functions, help ensure process rigor through step-by-step descriptions of agreed, standardized ways of doing ...
read more
Antibody-oligonucleotide conjugates (AOCs) are an emerging and exciting development in precision medicine. AOCs combine the specificity of antibodies with the gene-modulating potential of oligonucleotides, allowing them to act ...
read more
When we experience microbial recovery in our components, intermediates, or finished products, the first response may be one of panic. Think of it – a microscopic creature, almost alien, appearing out of nowhere with the potential ...
read more
True expertise in aseptic manufacturing is more than knowledge - it is a commitment to adapting practices to keep pace with emerging technologies, diseases, and regulatory requirements.
The pharmaceutical industry continuously ...
read more
Sterile compounding organizations, encompassing traditional pharmacies (503A) and outsourcing facilities (503B), are tasked with rigorous microbiological testing to ensure compliance with regulatory standards and to maintain ...
read more
Reliable microbial test results are pivotal for quality control laboratories. False positives resulting from secondary contamination make root-cause investigations necessary that lose time and cost resources, while false negative ...
read more
To a pharmaceutical microbiologist, there are two categories of finished pharmaceutical products: non-sterile and sterile. At the end of manufacturing, no microorganisms are present in sterile products. Examples of sterile ...
read more
This publication was developed prior to the publication of technical details on low-pressure Hydrogen Peroxide sterilization. That process is significantly different from the near-ambient pressure vapor processes discussed herein ...
read more
Over the past century, few species have experienced such a profound shift in public perception as the American horseshoe crab (HSC). Prior to 1920, millions of Limulus polyphemus were harvested for livestock feed and fertilizer. ...
read more
After years of research and development, the field of bispecific antibodies (BsAbs) is gaining momentum. More than a dozen bispecific antibodies have secured FDA approval. These new therapies have added much-needed therapeutic ...
read more
The purpose of this column is to highlight and summarize recent key patents in the pharmaceutical arena issued by the US Patent Office in October-November, 2024.
read more
A listicle is defined as “a piece of writing or other content presented wholly or partly in the form of a list.
read more
True expertise in aseptic manufacturing is more than knowledge - it is a commitment to adapting practices to keep pace with emerging technologies, diseases, and regulatory requirements.
The pharmaceutical industry continuously ...
read more
Oral drugs face major challenges like poor solubility, low permeability, and enzymatic degradation, which limit their effectiveness. This article explores cutting-edge strategies to enhance drug absorption through the lymphatic ...
read more
Early in 2023, Nelson Labs announced the expansion of pharma-testing capabilities and the designation of its Itasca, Illinois, facility as a new pharmaceutical center of excellence to serve the unique and ever-growing needs of ...
read more