BioPharm International, January 2008 - BioPharm International

ADVERTISEMENT

ADVERTISEMENT

BioPharm International, January 2008
Features
How to Avoid Becoming a Biotech Zombie Part 1
By Carmen Medina , Joseph J. Villafranca, PhD
Biotechs can avoid becoming a zombie by having a thorough business plan and a clear focus.
Rapid Development and Optimization of Cell Culture Media
By Min Zhang , Avril Lawshé , Kerry Koskie , Terrell Johnson , Matthew V. Caple , James S. Ross
Chinese hamster ovary (CHO) cells are used extensively in the biopharmaceutical industry to produce recombinant proteins that require post-translation modification for full biological functionality. Optimization of culture conditions for recombinant CHO cell lines presents challenges in light of the diverse nutritional requirements observed with different clonally derived cell lines.
Elements of QbD in Development and Scale-Up of Freeze-Dried Parenterals
By Steven L. Nail , Jim A. Searles
Design space concepts are key to a successful technology transfer.
Satisfied, Well Paid, and Secure
By Laura Bush
Our second annual salary survey assesses not only how much people earn, but also how they feel about it.
Columns and Departments
Biotech Manufacturers Face a Challenging 2008
By Jill Wechsler
The new year begins on a note of optimism. A major breakthrough in stem cell research promises to open the door to new biomedical research opportunities. The drawn-out Congressional debate over user-fee reauthorization and drug safety regulation is over, and most parties seem satisfied with resulting compromises. The vaccine industry is experiencing a resurgence after years in the doldrums, with important new vaccines on the market and more under development. And unlike many previous years, the US Food and Drug Administration (FDA) had a confirmed commissioner for all of 2007 and relatively stable leadership.
Look Beyond Biopharmaceutical Industry Hype
By Jim Miller
A CMO faces significant risk of lost revenues and profits if the product fails in clinical trials or doesn't meet sales projections.
How Small Biotechs Should Protect Their Interests During Mergers and Acquisitions
By Sergio Garcia
Strategic alliances and partnering deals were a big biotech news story during 2006—with deal values setting an all time record of over $23 billion for the year. The strategic partnering trend continues during 2007 and in this column we present some frequently asked questions and answers about the merger and acquisition (M&A) activity in the life sciences sector.
Evaluating China's Intellectual Property Situation
By Jim J. Zhang
The Chinese government is making consistent efforts to strengthen IP protection.
Biopharmaceuticals in India: A New Era
By Eric S. Langer
India's biopharmaceutical industry, which was relatively modest only a decade ago, is expected to generate almost $2 billion in sales in 2008, making it one of the largest biopharmaceutical segments in Asia.1 According to BioPlan Associates, Inc., and the Society for Industrial Microbiology's newly published joint study, Advances in Biopharmaceutical Technology in India, the Indian biopharmaceutical industry is growing 25 to 30% per year.1
Preparing for Your First IND Submission: The Devil is in the Details
By Conrad J. Heilman, Jr., PhD , Joseph J. Villafranca, PhD
In the process of developing breakthrough biopharmaceuticals with profound therapeutic promise, the many detailed requirements for a successful investigational new drug (IND) submission may seem petty, but they are not. With an IND, you are essentially moving from the cloistered world of the laboratory into a highly regulated industry where details not only matter, but are also greatly magnified by the overriding requirements of safety and efficacy. Treat those details with forethought and you will eventually succeed. Treat them as an afterthought and all of your pioneering science, state-of-the-art technology, and therapeutic ambition could come to nothing. At the very least, your progress to market could be delayed significantly. And if, like most young biopharmaceutical companies, you are on a short financial leash, such delays can be fatal for securing additional funding.
It's the Intangibles that Matter
By Laura Bush
The number one source of job satisfaction? A sense of accomplishment from a job well done.

ADVERTISEMENT

ADVERTISEMENT

Click here