GEN-MKT-18-7897-A
Jul 14, 2017 | Blogs, Environmental / Industrial | 0 comments
In today’s technical blog, I’m talking about the cosmetics industry so let’s get right to it. According to a Research and Market report, “The Global Cosmetic market was $460 billion USD in 2014 and is estimated to reach 675 billion USD by 2020, growing at a rate of 6.4%.”1 The U.S. leads the pack with a reported $62 billion in revenue earned in 20162. So, what am I getting at? We know earnings are strong and consumers like their products. But the question remains, are these products that you put on your skin, hair, and ingest safe? Such is the thinking of scientists like me and other chemists who are routinely tasked with detecting minimal levels of potentially harmful ingredients in personal care products against ever-changing global regulations.Read the Tech Note >
Take the United States for example where, apart from color additives, cosmetic products do not require Food and Drug Administration (FDA) approval3. While in other regions such as the European Union and China, governments have put in place stricter regulations, prohibiting the use of hormones, antibiotics, and disinfectants in cosmetics. To enable labs to have options for meeting regulations such as these, I wanted to mention the following technical note, Use of X500R QTOF for Monitoring of Additives in Cosmetics, in which our researchers established a highly selective, high throughput method for rapid screening and quantification of prohibited drugs in cosmetics. Some of the benefits of this method include:
More Information on Cosmetic Regulations and Lab TestingLabs know that industry regulations are ever changing. For example, in 2015, two U.S. senators proposed legislation to give the FDA more power to regulate cosmetics.4 More recently, the FDA proposed a limit to adding lead in lipstick to 10 parts per million (ppm), an effort supported by the Personal Care Products Council. It’s not just the U.S. which is making efforts to monitor the cosmetics industry more closely. The Albanian Parliament too recently passed a law by the European Council Regulation no. 1223/2009.5 Additionally, the EU Cosmetics Committee recently voted for banning three more fragrance allergens.6
The point of which is that for labs such as CROs to stay in business, they must be ready for anything that comes their way. The cosmetic market may be growing, but so too is global awareness about harmful ingredients both amongst the public and manufacturers/governments are not sitting idle. The X500R QTOF System, as featured in the above technote, is a highly accurate, and affordable instrument that is sensitive enough to meet low levels of detection in the cosmetics products and fits into any lab as a benchtop product.
Finding the right information shouldn’t slow you down. Whether you’re troubleshooting your mass spec, learning something new, or optimizing performance, access to the right resources at the right moment makes all the difference.
As an analytical strategy, middle-down mass spectrometry (MS) workflows characterize biotherapeutic proteins by analyzing large, digested protein fragments or defined subunits, rather than fully intact proteins (top-down) or digested peptides (bottom-up). A middle-down strategy combines the strengths of top-down and bottom-up approaches by delivering high sequence coverage and structural specificity while maintaining relatively simple sample preparation. In practice, middle-down analysis enables accurate mass measurement, rapid sequence confirmation, and localization of key post-translational modifications (PTMs) on protein subunits that are directly relevant to product quality.
In biopharmaceutical development, sequence variants (SV) are considered an inherent risk of producing complex proteins in living systems. Sequence variants are unintended changes to the amino acid sequence of a biotherapeutic and can be caused by errors in transcription or translation in the host cell, or cell culture and process conditions. Detailed analysis of SVs is important in process and product development to ensure the drug’s safety and efficacy. Even low‑level sequence variants can have significant implications for product quality, safety, and efficacy, making their accurate detection and characterization a critical requirement across development, process optimization, and regulatory submission.
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