Tag Archives: Catalent Pharma Solutions

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Catalent Expands Capabilities In Testing For Melamine In Food And Medicinal Products

At a time when melamine-contamination has received global attention, Catalent Pharma Solutions continues its legacy of innovation by rapidly developing new FDA guidance-compliant tests for trace amounts of key contaminants in food and medicine. Incidents of melamine contamination in milk products, baby formula, dairy and non-dairy products manufactured in China have been widely reported, leading to product recalls and increased inspections by the FDA.

The current good manufacturing practice (CGMP) regulations require that all components (i.e. ingredients or raw materials) be tested before they are released for use in the manufacture or preparation of drug products (21 CFR 211.84). It is critical that all manufacturers determine whether they are using an at risk component for melamine contamination to manufacture or prepare a drug product.

In response to the FDA’s new guidance titled “Pharmaceutical Components at Risk for Melamine Contamination,” Catalent has successfully qualified a method for determining if suspect excipients are contamination-free to within 2.5 parts per million. The method is based on that provided by the FDA (Laboratory Information Bulletin No. 4423 “GC-MS Screen for the Presence of Melamine, Ammeline, Ammelide, and Cyanuric Acid”).

Catalent is now able to provide its customers successfully qualified and validated limits tests for trace levels of melamine, ammeline, ammelide, and cyanuric acid in lactose.

Melamine is a compound made of carbon, nitrogen and hydrogen and is typically combined with formaldehyde to produce a durable and moldable plastic that is fire and heat resistant. Trace amounts of melamine have recently been discovered to be toxic to dogs, cats, pigs, and chickens by veterinary scientists after kidney or renal failure occurred due to their food being contaminated with the chemical.

“Catalent is proud to have satisfied the demanding regulatory standards the US FDA has provided for detecting melamine,” said Kent Payne, Vice President and General Manager of Catalent’s Respiratory, Analytical and Biotechnology Services business. “Detecting trace levels of melamine in food and medicinal products at these levels is a challenging process, but is key to help avoid future public health crises. In order to support this critical public health need, Catalent can expedite this testing and provide results within 48 hours from receipt of samples

Fore more information on the US FDA guidelines, please visit:
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm176088.htm.

About Catalent
Headquartered in Somerset, New Jersey, Catalent is one of the leading providers of advanced dose form and packaging technologies, and development, manufacturing, packaging and printing services for pharmaceutical, biotechnology and consumer healthcare companies in nearly 100 countries. Catalent applies its local market expertise and technical creativity to advance treatments, change markets and enhance patient outcomes. Catalent employs approximately 9,500 at 30 facilities worldwide and in fiscal 2009 generated more than $1.6 billion of annual revenue. For more information, visit www.catalent.com.

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Biotech, Business of Medicine, Healthcare, Healthcare Information, Medicine, Pharmaceuticals

Catalent To Present Webinar On Stabilities Studies In Pharmaceutical Development

Catalent Pharma Solutions will host a free Webinar featuring Senior Manager, Wei Pan, Ph.D. RAC and Kathy Waddle, Director, Stability QC Biology. The one-hour Webinar will cover stability studies as a critical part of the drug development process and the vital role they play for drug product marketing approval. The Webinar, titled “Stability Studies in Pharmaceutical Development,” will be held on Friday, November 20, 2009 at 2 p.m. (EST). To register for the Webinar please visit: https://www2.gotomeeting.com/register/280747146.

The presentation will address the principles and practices of stability studies in the drug development process. Pan and Waddle will discuss the framework of the FDA cGMP guidelines as expressed in 21CFR211. Additionally, the Webinar will provide a comprehensive review of ICH and WHO stability guidelines by discussing the strategy used in stability protocols designed to support global registration.

Stability studies are conducted at all phases of the drug development cycle for different purposes with the ultimate goal of having a stable product on the market. During development, stability studies are conducted to support the formulation development and safety and efficacy claims of investigational new drugs. At registration, they are conducted to ascertain the quality and shelf-life of the drug product in their intended packaging configuration. After approval, the stability studies are conducted to ensure the quality of production and to support site or other changes to the product.

For more information on Catalent’s broad range of drug and biologic development services, go to www.catalent.com/development.

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Dr. Hans Westenburg, A Senior Scientist At Catalent Pharma Solutions, Will Present At The TIDES 2009 Conference

Dr. Hans Westenburg, a senior scientist of structural characterization and analysis at Catalent Pharma Solutions, will present this month at the TIDES 2009 Conference to be held in Las Vegas, NV, May 17-20, 2009. The conference agenda was put together by leaders in oligonucleotide and peptide development and manufacturing, and features a program full of novel, in-depth scientific presentations related to oligonucleotide and peptide drug development and manufacturing. The TIDES conference is produced by IBC Life Sciences.

Dr-Hans-WestenburgDr. Westenburg’s poster presentation is titled “Teriparatide Degradation Products Identified by Accurate Measured Mass LCMS.” Presentation abstract: The human parathyroid hormone (PTH) contains 84 amino acids. The biologically active region is 34 N-terminal amino acids (teriparatide) from the recombinant human PTH. Teriparatide is the first FDA approved agent for the treatment of osteoporosis that stimulates new bone formation. The safety of the drug product is dependent not only on the toxicological properties of the active drug substance, but also on the impurities that it contains. Therefore, identification of impurities in the drug product is an important part of drug development and regulatory assessment. Accurate measured mass liquid chromatography/mass spectrometry (LCMS) is a rapid technique to identify impurities at levels as low as 0.02% in the drug product. LCMS enabled the identification of fifteen low level impurities in teriparatide.

Based in Catalent’s Trade Place facility in San Diego, CA, part of the organization’s Respiratory, Analytical and Biotechnology group, Dr. Westenburg works to structurally identify impurities for virtual, generic, small-, and mid-size pharmaceutical companies. In his current capacity, he has been able to identify impurities belonging to a large number of structural classes. The identification of these impurities supports the client to enable greater reporting thresholds or, in some instances, identify an impurity causing discoloration of a drug substance or product. During the past two years, Dr. Westenburg has routinely monitored low level genotoxic impurities by QTOF LCMS in a drug product. Overall, the majority of his work is impurity identification for companies concerning impurities in drug substances [Q3A(R2)] and impurities in drug products [Q3B(R2)], in compliance with the International Conference on Harmonization (ICH) guidelines.

About Catalent
Headquartered in Somerset, New Jersey, Catalent Pharma Solutions is a leading provider of advanced dose form and packaging technologies, and development, manufacturing and packaging services for pharmaceutical, biotechnology and consumer healthcare companies in nearly 100 countries. Catalent applies catalentits local market expertise and technical creativity to advance treatments, change markets and enhance patient outcomes. Catalent employs approximately 9,100 at more than 30 facilities worldwide and in fiscal 2008 generated more than $1.8 billion of annual revenue. For more information, visit www.catalent.com.

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Biotech, Business of Medicine, Healthcare, Medicine, Pharmaceuticals

Catalent Analytical Team Member to be Published in Journal of Pharmaceutical Research

Catalent Pharma Solutions, a worldwide leading provider of advanced technologies for pharmaceutical, biotechnology and consumer health companies, will be featured in the upcoming April edition of Journal of Pharmaceutical Research. Stephen P. Mayock, a member of Catalent’s analytical team, was a major contributor to the article that conveys the present challenges and future relevance of the science of USP 1 and 2 dissolution.

The article begins with the scientific origins of the dissolution test and discusses the roles of dissolution in product development, consistent batch manufacture and stability testing. It also reviews the ultimate role of dissolution testing where the end results correlate to in vivo results. Other topics that are covered in the article include the mechanical calibration versus performance testing, variability and hydrodynamics of USP Apparatus 1 and 2 and new initiatives in the industry such as quality by design, process analytical technology and design of experiment.

Mayock is the senior manager in Catalent’s Stability and Analytical Services Group. Catalent’s analytical team is part of its Respiratory, Analytical and Biotechnology group, with sites in the Research Triangle Park, N.C., San Diego C.A., and Middleton, W.I. Mayock joins fellow authors Vivian Gray, Gregg Kelly, Min Xia, Chris Butler and Saji Thomas. The article has been available online to subscribers since Jan. 25, 2009, and the print version will be available in the April edition.

About the Journal of Pharmaceutical Research
Pharmaceutical Research, an official journal of the American Association of Pharmaceutical Scientists, presents papers that describe innovative research spanning the entire spectrum of drug discovery, development, evaluation, and regulatory approval. Small drug molecules, biotechnology products including genes, peptides, proteins and vaccines, and genetically engineered cells are an integral part of papers published.

About Catalent
Headquartered in Somerset, New Jersey, Catalent is one of the leading providers of advanced dose form and packaging technologies, and development, manufacturing and packaging services for pharmaceutical, biotechnology and consumer health companies in nearly 100 countries. Catalent applies its local market expertise and technical creativity to advance treatments, change markets and enhance patient outcomes. Catalent employs approximately 9,500 at more than 30 facilities worldwide and generates more than $1.8 billion of annual revenue. For more information, visit www.catalent.com.

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