Product Safety Articles & Analysis: Older
29 articles found
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. ...
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. ...
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 ...
Host Cell Residual DNA (rcDNA) refers to fragments of DNA derived from host cells that may be present in biological products. These products must not contain foreign substances, particularly host DNA, to avoid immune rejection and potential threats to life safety. ...
Helping Students Navigate CareersNavigating careers in a complex job market is much more difficult for today’s students than in the past. Their talents are in high demand and they have choices that were not available to their parents or ...
There he played a key role in driving the company’s global market and portfolio of commercial and R&D products, leveraging his deep expertise in innovating products and services aligned to the market. ...
ByLifebit
The basic requirements of pharmaceutical preparations are safety, efficacy, and stability. Drug stability means that a drug product should maintain the same properties and characteristics as it was at the time of production and within the specified time frame. The stability of pharmaceutical preparations directly affects the effectiveness and ...
With respect to their use in gene therapy, we can assess viral vectors in terms of their safety, production robustness and scalability, ability to target specific tissues (tropism), and packaging capacity. ...
Gene-modified cell therapies (GMCTs) represent the most effective therapeutic platform for many patients with advanced diseases including relapsed and refractory leukemia, non-Hodgkin lymphoma, and other blood cancers [1]. Specifically, chimeric antigen receptor T cell (CAR-T) therapies targeting CD19 have demonstrated remarkable responses and possibly cures in patients with advanced acute ...
In previous blog posts, we have explored the fact that many drugs, vaccines and pharmaceutical products require refrigerated conditions in order to maintain efficacy. We also examined the importance of minimizing temperature excursions during transportation. Establishing a drug stability budget can minimize discards and ensure a quality product is delivered to the end-user. We know that ...
ByAKCP
This accounts for all segments of the market, including application of the product in pharmaceuticals, medicinal and therapeutic products, skin care products, and fiber/textiles. This growth, and the confidence in hemp products, will require applicable testing to ensure product quality and ...
COVID-19 and its pressure on nearly every aspect of human life has put a gigantic emphasis on rapid development of prescriptives, vaccines, and accelerated means for pharmaceutical mass-production. Newer highly potent active pharmaceutical ingredients (HPAPI) hold great promise for the health of the planet, while posing manufacturing challenges for plant workers and their ...