Genetic Engineering & Biotechnology News recently interviewed Maura Kibbey, Ph.D., senior scientific liaison, biologics and biotechnology, USP, on the topic of residual host-cell protein and DNA in biotech products.
Contributed Articles & Editorials
USP frequently contributes articles and editorials to professional media. Visit the links below to access full articles. Please note: you may be directed to an outside web page.
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2012
- U.S. Pharmacopeia Hosts Workshop on Bioassays
- Drug Discovery & Development (11/2012)—Bioassays are central to measuring the potency and activity of biological drugs. USP's Fifth Bioassay Workshop on December 4–5, 2012, is featured in Drug Discovery & Development.
- Elemental Impurities Control
- Contract Pharma (10/2012)—USP's Athony DeStefano and Kahkashan Zaidi discuss the impact of USP's new elemental impurities standards on contract pharmaceutical organizations.
- USP Further Strengthens Quality Standards for Heparin
- BioPharm International (10/2012)—USP's Anita Szajek discusses Stage 3 revisions of USP's heparin monograph standards.
- The Impact of USP's New Elemental Impurities Standards on Manufacturers, Suppliers and Contract Laboratories
- American Pharmaceutical Review (10/2012)—USP's Anthony DeStefano and Kahkashan Zaidi discuss new standards related to elemental impurities.
- Complex Supply Chains Demand a Holistic Approach to Protect Patients
- Pharmaceutical Commerce (08/2012)—As the international supply chain growns more complex, the need for industry standards to help protect pharmaceutical products and ingredients is increasingly important. In this article, USP's Desmond Hunt explains the work that USP is doing to develop supply chain integrity standards.
- Regulatory Report: Beverages at the Forefront of Innovation in Booming Functional Food Market
- Food Safety Magazine (06/2012)—USP's Markus Lipp discusses the challenges related to functional beverages and how FCC standards can play an important role in helping to ensure the authenticity of innovative ingredients used in these products.
- Inside USP: US Pharmacopeia Proposes New Standard on Glass Quality
- Pharmaceutical Technology (06/2012)—With the growing problem of glass particles in injectable medications leading to product recalls, USP's Anthony DeStefano and Desmond Hunt explain USP's newly proposed general chapter on glass durability.
- Proposed Standards for Immunogenicity Testing
- Genetic Engineering & Biotechnology News (06/2012)—USP's Maura Kibbey discusses unwanted immunogenic responses associated with biologic medicines and USP's proposed new general chapter that seeks to address anti-drug antibodies.
- USP Introduces Useful Guidelines on Sterlization and Contamination Control
- Pharmaceutical Processing (05/2012)—Microbial contamination is a problem that all manufacturers must pay close attention to during manufacturing. In this particular article, USP's Radhakrishna Tirumalai explains USP's general chapters pertaining to this topic and how USP will be working with industry and FDA to revise these standards.
- Pushing for Probiotic Standards
- Nutritional Outlook (04/2012)—As probiotics continue to increase in popularity, the need for public standards to help ensure the indentity, quality, and purity of these high-value ingredients grows as well, USP's Markus Lipp and Kristie Lauvrick explain.
- Regulatory Report: Ingredient Adulteration Undermines Food Safety
- Food Safety Magazine (03/2012)—USP's Markus Lipp discusses the threats that contamination and adulteration pose to the food supply.
- Microbiology Expert Committee Takes Closer Look at Contamination, Antibiotic Potency and Modern Methods
- A3P Association (Association pour les produits propres et stériles) (02/2012)—A major concern for manufacturers is the extent of microbial contamination in a finished product. In this piece, USP’s Radhakrishna S. Tirumalai discusses what the USP Microbiology Expert Committee is doing to several new or revised General Chapters pertaining to this topic.
- Inside USP: Global Harmonization Presents Opportunities and Challenges
- Pharmaceutical Technology (01/2012)—USP’s Anthony DeStefano and Kevin Moore give a history of the Pharmacopoeial Discussion Group, its efforts to harmonize standards and how industry can help improve these efforts.
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