BioPharm International, January 2005 - BioPharm International

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BioPharm International, January 2005
Immunogenicity
A Risk-Based Approach to Immunogenicity Concerns of Therapeutic Protein Products, Part 3: Effects of Manufacturing Changes in Immunogenicity and the Utility of Animal Immunogenicity Studies
By Amy S. Rosenberg, MD , Alexandra Worobec, M.D.
Manufacturing changes — such as changes in formulation or source material — can impact a product’s immunogenicity.
Business Strategies
Conceptualizing, Making, and Selling the Brand
By Rick Keating
In the increasingly competitive world of drug discovery and development, the role of branding is more important than ever. With all the various sectors — big pharma, generics, specialty pharma, and biotechnology —vying for limited dollars, branding must begin early in the development process and, ultimately, play an integral role not only in taking a product to market, but also in sustaining that product against competition, perceived and real.
Managing the Transition from Research to Development: Implementation of a Manufacturing Strategy
By Michael S. Wyand
In order to institute a GxP mindset across the organization, support and respect for quality systems should come from the top down.
Plant-Made Biopharmaceuticals
US Regulation of Plant-made Biopharmaceuticals, Part 1
By Sharon A. Berberich , Rebecca A. Devine
Transgenic plant systems promise lower production costs since plants can be grown in a field instead of a cell-culture facility. Also, they provide an alternative production system for proteins that are difficult to express in cell culture.
Columns and Departments
Pleated Membrane Filters Improve Process Economics
By Monica Cardona , Christian Martin
The drive to develop better, faster, and smaller — in other words, more efficient — products is a universal trend in the modern world. This trend has profoundly impacted many industries from microelectronics to packaging equipment. In the biopharmaceutical industry, the need to speed and simplify the long and complex drug manufacturing processes brings additional challenges, such as meeting regulatory requirements.
Editorial—Take a Hike, Chicken Little
By Carol L. Fisher
You don't need me to tell you how bad the news has been for the pharmaceutical industry in the last two months. First, it was antidepressants for children, then Vioxx. It took maybe 48 hours before the first tort request hit the airwaves, asking to hear from those who'd experienced heart attacks or strokes after taking the drug. Celebrex came next, followed by NIH announcing it put the kibosh on a study of naproxen.
Regulatory Beat: Policy Makers will Focus on Drug Safety and Costs in 2005
By Jill Wechsler
The re-election of George W. Bush as president and continued Republican control of Congress will shape the healthcare policy agenda for the coming year. Major initiatives to expand healthcare coverage to the uninsured or reform Medicaid are off the administration's priority list, but social security and tax reform may provide additional tax incentives for individuals and small businesses to obtain health coverage and establish health savings accounts.
StreetTalk: Trends to Watch in 2005
By Brian O'Connell
For years, the pharmaceutical sector has provided a safe haven for investors. I'm not so sure that will be the case in 2005.
Final Word: Suppliers Can Help Companies Achieve Speed to Market
By Mike Sullivan
In today's competitive and fast-paced environment, owner companies must get products to market quickly and efficiently. By redefining how they provide services and products, suppliers can enhance their value and help owner companies reap the greatest financial returns.
Affinity Chormatography Removes Endotoxins
By Ivars Bemberis , Masayo Sakata, PhD , Chuichi Hirayama, PhD , Masashi Kunitake, PhD , Yoshihisa Yamaguchi , Minoru Nakayama , Masami Todokoro, PhD
Protein solutions used for research, vaccines, or therapeutics need to be free of contaminants. One of the chief concerns is the presence of endotoxins (lipopolysaccharides) because their removal from protein solutions is a challenge. Typically, removal techniques utilize adsorption onto surfaces of beads in batch reactions, onto beads packed in columns, or onto membrane surfaces.

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