Refine by
Product Safety Articles & Analysis
40 articles found
As the end of the year approaches, many clinicians look for smart ways to invest in their practice while reducing taxable income. One powerful opportunity often overlooked is the Section 179 tax deduction — a U.S. tax incentive that allows businesses, including dental and medical practices, to deduct the full purchase price of qualifying equipment in the year it is placed in service. If ...
Cancer Treatment: By delivering genes that can induce cancer cell death or enhance the immune response against tumors, adenoviruses are part of innovative approaches in oncology. The Adenovirus Production Process Producing adenoviruses involves a series of carefully controlled steps to ensure the final product’s safety and effectiveness. ...
As spring arrives, so does a renewed focus on cleaning, quality, and process validation in pharmaceutical facilities. Whether it’s a routine seasonal turnover or preparation for ramped-up production cycles, spring is a critical time in the pharmaceutical industry for equipment maintenance, cleaning validation, and ensuring product purity. Behind every cleanroom, batch reactor, or ...
As spring arrives, so does a renewed focus on cleaning, quality, and process validation in pharmaceutical facilities. Whether it’s a routine seasonal turnover or preparation for ramped-up production cycles, spring is a critical time in the pharmaceutical industry for equipment maintenance, cleaning validation, and ensuring product purity. Behind every cleanroom, batch reactor, or filtration ...
Pharmaceutical manufacturers face growing challenges in ensuring product quality, maintaining regulatory compliance, and safeguarding against counterfeit drugs. ...
Introduction Good Manufacturing Practice (GMP) cell banks play a crucial role in the biopharmaceutical industry, serving as foundational repositories of cell lines used for the production of therapeutic biological products. Characterization of these cell banks is essential to ensure the safety, efficacy, and consistency of the biopharmaceuticals ...
By analyzing changes in cell proliferation, cytokine production, and apoptosis, scientists can gather crucial data on immunotoxic potential. ...
HCP (Host Cell Proteins) residual detection is a key quality control step in the field of biopharmaceuticals, aiming at ensuring that the proteins of the host cells used for producing therapeutic proteins in any cell-based production system are maintained at acceptable low levels in the final drug product.ImportanceHCPs are impurities during the production ...
In biopharmaceuticals, cell lines (hosts) are typically used to produce proteins or other biological products. These cell lines could be bacteria, yeast, mammalian cells, etc. After the production process is over, the product needs to go through multiple purification steps to remove non-target impurities, one of which is the protein of the host ...
For instance, when producing biopharmaceuticals like monoclonal antibodies, clonality analysis ensures that the production cell line is purely derived from a single, well-characterized clone, thus enhancing product safety and efficacy. ...
Introduction The pharmaceutical industry faces stringent regulatory requirements to ensure the safety, efficacy, and quality of drug products. Among these, Current Good Manufacturing Practice (CGMP) guidelines set by agencies such as the U.S. ...
Enhancing cGMP Capacity: A Prerequisite for Efficient Therapies To accompany this technical transformation, expansion in cGMP capacity is a necessity. cGMP represents regulations enforced by the US Food and Drug Administration (FDA) to ensure proper manufacturing, control, monitoring, and management of gene therapy products. This regulates the quality and consistency of the end ...
It is worth mentioning that the use of dietary supplements has increased significantly over the years, prompting scientific review and research into their efficacy and safety. Some Popular Dietary Supplement Ingredients Vitamins Vitamins are organic compounds that are essential for various physiological functions. ...
Pharmaceutical excipients play a crucial role in the formulation and production of drugs, supporting their stability, efficacy, and palatability. ...
With an increasing demand for pharmaceutical products, there has been a need for faster and more efficient packaging solutions on a commercial scale. ...
Precision is not just a preference but a stringent requirement in medical equipment manufacturing. At the heart of this precision lies the role of medical-grade welding gas mixers, an important component in ensuring high-accuracy welding applications, particularly in environments where consistency and quality cannot be compromised. This blog post defines medical-grade welding gas mixers and ...
For instance, when producing biopharmaceuticals like monoclonal antibodies, clonality analysis ensures that the production cell line is purely derived from a single, well-characterized clone, thus enhancing product safety and efficacy. ...
Individuals with these conditions often suffer from insufficient endogenous enzyme production. Native Porcine Pancreatin supplements provide exogenous enzymes to help alleviate digestive issues and nutrient malabsorption. ...
Therefore, for the development of Fc-Fusion-related drugs, it is necessary to gain insight into the impact of glycosylation on product quality through various characterization techniques and to closely control the glycosylation of the target product to ensure proper safety and efficacy. ...
Viral vector manufacturing During process development/optimization, the FDA mandates that overall product characterization under cGMP (current Good Manufacturing Practice) follows SISPQ (Safety, Identity, Strength/Potency, Purity, and Quality). l Safety: The product does not elicit unexpected side effects when used ...