July 26, 2010 – Ana T. Menendez, Ph.D., Senior Director of Biotechnology at Catalent Pharma Solutions, has been invited by the Taiwan Biotech Organization to lead a one-day workshop on GMP Bioassay Validation and GLP Immunogenicity Method Development on July 28, 2010. Dr. Menendez will also be delivering a podium presentation titled “Effective Transfer of Complex Biological Method” at the Key Technology Forum in Protein Drug Development, July 29, 2010. The Forum will focus on upstream process development, downstream process development, analytical and bioassay method development, formulation development and manufacturing, facility construction, and quality assurance and regulatory issues.

As Senior Director of Biotechnology at Catalent, Dr. Menendez is responsible for the release tests required to verify the functionality and purity of biotechnology products and the complex processes involved in their manufacture. Dr. Menendez implemented biotesting at Catalent and currently leads the following laboratories at the North Carolina Research Triangle Park facility: Cellular Technologies, Molecular Technologies, Virology and Analytical Biosafety. The expertise of the department ranges from proteins (i.e., monoclonal antibodies, enzymes, growth factors) to therapeutic viruses, bacterial vaccines and aptamers. Menendez is an international instructor on Bioassay Development and Validation and a frequent speaker at biopharmaceutical conferences.

For more information on Catalent’s broad range of biopharmaceutical development services including bioanalytical and immunogenicity development solutions, go to www.catalent.com/development.

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 9,000 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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July 26, 2010 – Corinne Mounier-Lee, Ph.D., Principal Scientist at Catalent Pharma Solutions, will deliver a presentation titled “Enhancing Analytical Quality Through the Use of UPLC: One Method in Place of Two” at CBI/IVT’s 7^th Annual Method Validation Conference, July 28-30, 2010 in San Francisco, CA. The three-day conference is designed for those who manage or execute the validation of analytical methods for the quality control of small and large molecule pharmaceuticals, biopharmaceuticals and biologics.

Dr. Mounier-Lee will detail how a UPLC method was developed and validated for simultaneous quantitation of related substances in a combination drug product containing two active pharmaceutical ingredients (APIs).  The method was then shown to separate the four known degradation products as well as API-related impurities and unknown related substances.  This enhanced UPLC method allows for more reliable and efficient testing of the product relative to the current state in which testing was conducted via two separate HPLC methods.

Dr. Mounier-Lee received her B.S. in Chemistry from the Ecole Supérieure de Chimie Industrielle de Lyon, France, and her Ph.D. in Chemistry from Emory University in Atlanta, Georgia, USA, followed by a NIH postdoctoral research position at the Georgia Institute of Technology in Atlanta, Georgia, USA. She specializes in liquid chromatography, high-pressure liquid chromatography, gas chromatography, headspace analysis, and dissolution testing.

For more information on Catalent’s broad range of biopharmaceutical development, go to www.catalent.com/development.

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 9,000 at 30 facilities worldwide and in fiscal 2009 generated more than $1.6 billion of annual revenue.  For more information, visit www.catalent.com.

Dr. Menendez’s workshop is designed to provide a thorough understanding of the scientific and regulatory expectations to detect and characterize antibodies to therapeutic proteins. The presentation starts with a description of the biological mechanism responsible for immunogenicity and by interpreting the recommendations of major regulatory and industry documents. The workshop continues by demonstrating logical pathways to select, standardize and validate correct immunogenicity methods then execute sample analysis. The final section reviews strategic paths to evaluate risk and manage immunogenicity issues to not only be successful in the clinic but also throughout the entire life cycle of a drug. Case studies will be used throughout the workshop to demonstrate the various theoretical points.

As Senior Director of Biotechnology at Catalent, Dr. Menendez is responsible for the release tests required to verify the functionality and purity of biotechnology products and the complex processes involved in their manufacture. Dr. Menendez implemented biotesting at Catalent and currently leads the following laboratories at the North Carolina Research Triangle Park facility: Cellular Technologies, Molecular Technologies, Virology and Analytical Biosafety. The expertise of the department ranges from proteins (i.e., monoclonal antibodies, enzymes, growth factors) to therapeutic viruses, bacterial vaccines and aptamers. Menendez is an international instructor on Bioassay Development and Validation and a frequent speaker at biopharmaceutical conferences.

For more information on Catalent’s broad range of biopharmaceutical development services including bioanalytical and immunogenicity development solutions, go to www.catalent.com/development.

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 9,000 at 30 facilities worldwide and in fiscal 2009 generated more than $1.6 billion of annual revenue.  For more information, visit www.catalent.com.

Research Triangle Park, NC, May 18, 2010 – Gregory T. Bleck, PhD., Senior Director of Cell Line Engineering for Catalent Pharma Solutions, will lead a webinar on the characteristics of effective mammalian cell line generation process for bio-pharmaceutical production on May 25, 2010 at 2pm EDT. To register for this complimentary webinar please visit: https://www2.gotomeeting.com/register/853525658.

Dr. Bleck’s presentation will explore how steps in the generation of mammalian cell lines have been optimized to make the process more efficient. Dr. Bleck will also outline certain approaches to improve timelines and throughput. Additionally, data collected from Catalent’s development of more than 200 cell lines, each producing a different antibody or recombinant protein, will be reviewed. An outline of Catalent’s current CHO cell line development process that consistently yields clonal lines and upstream culture conditions that result in 2.5 – 5.0 g/L antibody production in five to six months will be presented.

Dr. Bleck received his BS and Ph.D. from the University of Wisconsin-Madison, and performed postdoctoral work at the University of Illinois-Urbana working in the areas of gene regulation and expression, and joined Catalent Pharma Solutions in 1998. At Catalent, he transferred his knowledge of gene expression and transgenic systems to the development and continued optimization of retrovector expression systems and is one of the developers of the GPEx® gene expression technology. The GPEx® process is used at Catalent to develop high producing mammalian cell lines to be used for bio-manufacturing at the Middleton, WI facility.  Dr. Bleck has published more than fifty-five research papers and authored three book chapters. He has seven issued patents and eight patents currently under review.

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

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 9,000 at 30 facilities worldwide and in fiscal 2009 generated more than $1.6 billion of annual revenue.  For more information, visit www.catalent.com.

Research Triangle Park, NC, May 11, 2010 – Catalent Pharma Solutions’ industry experts will deliver scientific poster presentations this month at the 2010 AAPS National Biotechnology Conference, May 16-19 in San Francisco, California. This week of educational programming is dedicated to advancing health through innovations in biotherapeutics. Catalent is a sustaining sponsor of the 2010 AAPS National Biotechnology Conference.

Catalent biotechnology industry experts will present a total of four scientific posters for conference attendees. The presentations include:

Simone S. Cummings, Ph.D., Gwendolyn M. Wise-Blackman, Ph.D. will present “Overcoming Assay Drift and Multiple Matrix Interference Challenges in a PK ELISA.”

Poster Session: Tuesday, May 18, 11:00 AM – 6:00 PM.

Meet the author: 5:00 to 6:00 PM.

Dr. Joseph J. Lundquist, Ph.D., Ana T. Menendez, Ph.D. will present “A Novel High-Throughput Method for the Separation of a Derivatized Therapeutic Protein from Its Unmodified Form in Serum.”

Poster Session: Monday, May 17, 11:00 AM – 6:00 PM.

Meet the author: 5:00 – 6:00 PM.

Ana Menendez, Ph.D. will present “Standardizing Phase Appropriate Validation of GMP Potency Bioassays.”

Poster Session: Wednesday, May 19, 8:00 AM – 2:00 PM.

Meet the author: 1:00 PM – 2:00 PM.

Valerie A. Stratico, M.S., Ana T. Menendez, Ph.D., and Dr. Gwendolyn M. Wise-Blackman, Ph.D. will present “Overcoming Free Drug and Matrix Effects in Detecting Antibodies to a Pegylated Protein.”

Poster Session: Wednesday, May 19, 8:00 AM – 2:00 PM.

Meet the author: 1:00 PM – 2:00 PM.

Catalent possesses a diverse and highly integrated portfolio of biotechnology directed services designed to facilitate development from late target discovery and pre-clinical evaluation through clinical scale manufacturing in fill and finish of liquid or lyophilized biopharmaceutical drugs.

For more information on Catalent’s biopharmaceutical development services, go to www.catalent.com/development.

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 9,100 at 30 facilities worldwide and in fiscal 2009 generated more than $1.6 billion of annual revenue.  For more information, visit www.catalent.com.

Research Triangle Park, NC, April 30, 2010 – Alan D. Hendricker, Ph.D., principal scientist for Catalent Pharma Solutions, will be leading a discussion titled, “Migration Study Design and Case Study of Benzophenone Leaching from Packaging Componentry into Drug Product Solution” during PharmaED’s “Extractables and Leachables 2010” conference being held in San Francisco, California on May 3 through 4, 2010.

Dr. Hendricker’s talk will focus on a case study to source, quantitate and eliminate a contaminant migrating from the drug product container closure system into a nasal spray formulation during stability storage.  The results of this study will be presented.  Additionally, this talk will focus on migration study design.  Migration studies can be used to anticipate potential problems with leachables and provide relatively rapid answers concerning materials compatibility issues.  Linking migration studies to materials characterization studies will also be discussed in terms of understanding which species to focus on and applying appropriate analytical methodology.

Dr. Hendricker received his B.S. in Chemistry from Ohio University in Athens, Ohio, USA, and his Ph.D. in Chemistry from the Colorado School of Mines in Golden, Colorado, USA. He specializes in gas chromatography mass spectrometry (GC-MS), liquid chromatography mass spectrometry (LC-MS), and headspace analysis for volatile impurities.  Dr. Hendricker was a member of the PQRI working group that developed the Safety Threshold and Best Practices for Extractables and Leachables in Orally Inhaled and Nasal Drug Products in 2006. 

For more information on Catalent’s broad range of biopharmaceutical development services, go to www.catalent.com/development.   For more information on the conference please visit www.pharmaedresources.com.

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 9,100 at 30 facilities worldwide and in fiscal 2009 generated more than $1.6 billion of annual revenue.  For more information, visit www.catalent.com.

Research Triangle Park, NC, April 27, 2010 – Catalent Pharma Solutions’ industry experts will deliver scientific poster presentations this week at Respiratory Drug Delivery (RDD) 2010, April 25-29 in Orlando, Florida. RDD conferences are designed for academic and industrial scientists involved in the development, investigation, preparation and delivery of old and new therapeutic entities by aerosol systems. Catalent is a leader in the provision of development and manufacturing services to the pharmaceutical inhalation sector.

Justin P. Lacombe and David M. Wilcox will present a poster titled “Effect of Force-Displacement Profile on Spray Pattern of Pressurized Metered Dose Inhalers (MDI) using SprayVIEW® Instrumentation.”

H. Keith Miller, David M. Wilcox, Wendy Murray, Jeff Brown and Dr. Craig Davies-Cutting will present a poster titled “Impact of Metered Dose Inhaler Alignment in the Induction Port as a Source of Variability in Particle Size Distribution Determinations by Cascade Impaction.”

David M. Wilcox, Justin P. Lacombe, Jeff Brown, Monaca Richardson and Dr. Craig Davies-Cutting will present the final Catalent scientific poster titled “Case Study: Does Spray Pattern Testing Provide a Discriminating Measure of Metered Does Inhaler (MDI) Product Performance?”

For more information on Catalent’s pulmonary and nasal services, go to www.catalent.com/development <http://www.catalent.com/development> . For more information on the conference, please visit www.rddonline.org/conferences <http://www.rddonline.org/conferences> .

SprayVIEW® is a registered trademark of Proveris Scientific Corporation.

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 9,100 at 30 facilities worldwide and in fiscal 2009 generated more than $1.6 billion of annual revenue.  For more information, visit www.catalent.com <http://www.catalent.com/> .

Research Triangle Park, NC, October 27, 2009 – 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.
 
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.

 

SAN DIEGO, C.A. -- July 9, 2009 – Biotech Vendor Services, Inc. (BVS) is pleased to announce that our much anticipated “La Jolla Drug Development Day” will take place on Wednesday, July 22 at the Hyatt Regency Hotel in La Jolla, California.

The area’s top life-sciences companies will be in attendance to learn about strategies,  technologies and services that can aid companies through the drug development process.  La Jolla Drug Development Day will also include a panel of industry leading experts drawn from the San Diego area.  Lecture topics are scheduled to include:

• “The Pharmaceutical/Biotech/Academic Interface,” presented by Don A. Madren, R. Ph., MBA, Pfizer
• “Driving Innovation Through Partnering: Considerations for Effective Alliances,” presented by Roy Cosan, Johnson and Johnson
• “Strategies for Successful Drug Development within a Virtual Company,” presented by Tracy L. Lawhon, J.D., Tragara Pharmaceuticals.
• “Pre-launch Commercial Planning for a Pharmaceutical Product,” presented by Julia Brown, Targacept.
   

The premium sponsor for this year’s La Jolla Drug Development Day is Catalent Pharma Solutions. Catalent’s Respiratory, Analytical and Biotechnology group has a facility in San Diego (Trade Place) and is an active member of the local biotechnology and drug development community. Ana Menendez, Ph.D., senior director of biotechnology at Catalent, will be giving a presentation titled “Revised USP 111: A Valuable Tool to Expedite Your GMP Bioassay.”

“The mission of BVS is to continually contribute to the life science and local communities,” said Pamela Gardner, President and CEO, Biotech Vendor Services, Inc. (BVS).  “La Jolla Drug Development Day will be the sixth in a series of successful and well-attended conferences held by BVS in La Jolla, which are designed to offer the research and development community the opportunity to exchange scientific information, attend complimentary educational talks and also to collect donations for a local charity.  This year's event we will be accepting donations for the American Cancer Society, and canned goods and school supplies to support the efforts of Father Joe’s Villages.”

Although headquartered in San Diego, BVS has held more than 1,200 scientific on-site events at over 350 life-sciences companies nationwide, saving their clients’ time and money, a service of great value in these economic times.  In the San Diego area they have worked with more than 200 companies and institutions. 
 
The schedule for the conference includes networking from 4 - 5 p.m., panels and lectures from 5 - 7 p.m., and a reception beginning at 7 p.m. For more information on the conference please contact info@bvsweb.com or to register please visit http://www.bvsweb.com/php/register.php. 

About Biotech Vendor Services, Inc.
Biotech Vendor Services, Inc. (BVS) was founded in 2003 and provides cost saving and innovative vendor management services for biotechnology, pharmaceutical, and academic research departments. BVS’s specialty is the management of top-tier biomedical suppliers, delivering hundreds of vendor product shows, technical seminars and events across the US each year. More information at www.bvsweb.com.

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San Diego, CA – June 1, 2009 – An article co-authored by Dr. Hans Westenburg, a senior scientist of structural characterization and analysis at Catalent Pharma Solutions in San Diego, has been selected for the Jack L. Beal Award as best paper for 2008 by the American Chemical Society’s (ACS) Journal of Natural Products. The winning article is titled “Isolation and Structure Determination of Malevamide E, a Dolastatin 14 Analogue, from the Marine Cyanobacterium Symploca laete-viridis” and is the structure elucidation of a peptide from a marine cyanobacterium.

The Jack L. Beal Award is bestowed upon younger investigators, persons within 12 years of receiving their Ph.D. degree or within 10 years of gaining their first professional appointment. The award is named after a former editor of the Journal of Natural Product. All Beal Award winning papers can be accessed via the Journal of Natural Products website at http://pubs.acs.org/journal/jnprdf. The Journal publishes papers that make substantial and scholarly contributions to the area of natural products research. Contributions relate to the chemistry and/or biochemistry of naturally occurring compounds or the biology of living systems from which they are obtained. It is co-published with The American Society of Pharmacognosy.

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. For the past decade, the majority of his work has been in the impurity identification for pharmaceutical 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 its 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.