Tony Cundell, Ph.D.
Microbiologists have the continuing challenge of evaluating, validating, and implementing emerging testing technologies to enhance the performance of their laboratories. The now dated USP general informational chapter <1113> Microbial Characterization, Identification and Strain Typing endeavored to discuss a hierarchy of responses to microorganisms isolated from pharmaceutical manufacturing facilities, ingredients, and drug products based on the criticality of the testing.
David Gwyn
Amplexor’s David Gwyn reflects on what the last year has exposed in terms of RIM-related shortcomings, and how the Regulatory Affairs agenda should evolve in 2021 as pharmaceutical companies around the world reflect on a challenging nine months and face up to the prospect of continued disruption and uncertainty across all markets for some time to come.
Glenn Thorpe
Amid the evolution of the pharmaceutical industry, and more recently catalyzed by the coronavirus (COVID-19) and its implications on drug demand, delivery and the supply chain, parenteral drugs are experiencing increased demand. Whether administered intravenously, intramuscularly, or subcutaneously, the format creates new and critical avenues for drug delivery thanks to some favorable attributes around safety and efficacy.
Skin care has rapidly evolved as a concept over the last decade. Formulators in this field have worked tirelessly to bring topical solutions to market that effectively treat skin-related maladies, safely and consistently. In fact, a number of different active pharmaceutical ingredients (APIs) and biologics have been introduced during this time, from retinol and hyaluronic acid, to recent breakthroughs in topical probiotic and synbiotic technology.
PTI is a solutions provider for high-risk container closure integrity applications.
Dr. Johannes Kiefer
Ensuring the quality of pharmaceutical products is paramount for bringing them to market. This calls for analytical methods with high accuracy, specificity, and reproducibility. Nonlinear optical spectroscopy is an emerging toolbox in this context. This article provides an overview of the working principles and features of four techniques that have proven to be suitable for pharmaceutical analysis: second harmonic generation (SHG), coherent anti-Stokes Raman scattering (CARS), two-photon excitation laser-induced fluorescence (2P-LIF), and stimulated Raman scattering (SRS).
To ensure that a pharmaceutical product is safe for patients, it is mandatory to determine its bioburden in a tightly regulated quality control examination. Bioburden testing (or microbial limit testing) quantifies the number of aerobically growing bacteria, yeasts, and molds on surfaces or in solutions of, for example, raw materials, process intermediates and final products.
John Dubczak
Endotoxins are lipopolysaccharides (LPS) embedded in the outer membrane of Gram-negative
bacteria.
Undoubtedly, as manufacturers embrace more automation and digitization, it is invaluable to have computer systems that can be shared with partners and contract research organizations (CROs). There is a great deal of time savings and a streamlining of documentation (no physical paper trail), however there are also challenges that come with this approach.
Pyrogens are substances that induce a rise in the body temperature of a human being or an animal, to the point of becoming a health concern. The pyrogens that contaminate pharmaceutical products most frequently are lipopolysaccharides (LPS), also known as endotoxins, which are major components of the outer membrane of Gram-negative bacteria.
Sydney Jannetta
The race to develop and manufacture COVID-19 vaccines and treatments has put a spotlight
on Bacterial Endotoxins Testing (BET) and the criticality of this assay for research and
manufacturing.
Tom Zhang, Colton Wong
As 2020 comes to a close, drug development companies await the finalization and implementation of the ICH M10 guidance. The M10 guidance from the International Council for Harmonisation of Technical Requirements (ICH) focuses on the bioanalytical method development, validation, application and documentation of small and large molecular drugs.
Jim Renehan
For healthcare packaging, recent technology advancements have made in-motion weighing operations more precise and profitable.
Dr. Maaike Everts, Jerod Price
Injectables last year accounted for 49% of the global pharmaceutical clinical pipeline, an increase of 6% since 2015. Much of this growth towards injectables relates to the development of highly specialized or personalized drug products that require formulation technologies to deliver small molecules, peptides, proteins, and nucleic acids for new treatment modalities across a wide range of therapy areas. It is common to design such products for systemic delivery, localized delivery to sites such as the eye, joints, brain, organs, tumors and the spine, or the targeting of specific genes, cells or disease sites.
As the industry focuses its efforts to bring COVID-19 treatments swiftly to market, there is renewed interest in the development and manufacturing of vaccines.
Neelam Sharma, M.S., Hemant N. Joshi, Ph.D., MBA
The purpose of this column is to highlight and summarize recent key patents in the pharmaceutical arena issued by the US Patent Office from August-September 2020.