New expression systems compete for attention.
Jun 1, 2009
By:Eric S. Langer
New expression systems compete for attention.
 |
Biopharmaceutical companies can use Lean techniques to identify opportunities and eliminate wasteful and unnecessary activities.
May 1, 2009
By:Chris S. Driscoll
Use Lean techniques to improve manufacturing compliance
|
QbD can help satisfy FDA and EMEA requirements.
Jan 1, 2009
By:Sandy Weinberg, PhD
QbD can help satisfy FDA and EMEA requirements.
|
At a certain point, every biotech company must decide what type of company it is trying to be.
Sep 1, 2008
By:Joseph J. Villafranca, PhD, Conrad J. Heilman, Jr., PhD, Siddharth J. Advant, PhD
Every biotech company reaches a point in its development where it must decide what path it will take after it passes the start-up phase. This article discusses what the company must consider to decide what business model it will follow.
|
In a time of necessary speed and robustness, Quality by Design and Design Space are useful tools for companies to use.
Jul 1, 2008
By:Jason Kamm, Conrad J. Heilman, Jr., PhD
Quality by Design and Design Space can be used by companies to enhance process understanding, improve scientific rigor, and enhanced qualitative and quantative performance, as well as cost savings.
|
The principles of QbD can be applied to biotech development and manufacturing to help resolve many common issues.
May 1, 2008
By:Conrad J. Heilman, Jr., PhD
The principles of QbD can be applied to biotech development and manufacturing to help resolve many common issues. QbD scientifically provides a greater understanding of the complex relationships among product quality attributes, the manufacturing process, and clinical safety and efficacy by determining the various permutations of critical input variables that will keep the product within specification.
|
Mar 1, 2008
By:Siddharth J. Advant, PhD
A comprehensive process and analytical transfer package can speed up your product's time to market and save costs.
|
When preparing an IND submission, an open mind and ability to
Jan 1, 2008
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.
|
| 
