Archive for the ‘Biologics Manufacturing’ Category

Off-label uses… the Windex of the medical field?

You’ve heard the term, “cure-all”, I’m sure, but as we all know, there is no real “cure-all” in life. If you ever watched the movie, “My Big Fat Greek Wedding”, then you are all too familiar with the father of the bride who believes that Windex is the “cure-all” for everything. As he states in the movie, “from psoriasis to poison ivy, put some Windex on it!” Windex, however is not a magic potion. It is simply intended for cleaning windows, mirrors, glass shower doors, glass top stoves and more as stated on their website. In fact, Windex in high concentrations can be very caustic, because it contains ammonia! Maybe the father of the bride should have done some research before promoting Windex’s unapproved uses!

In the medical field, doctors, like the father of the bride in the movie, use many products for unapproved uses. In our industry, the Food and Drug Administration (FDA) requires that medical devices, drugs, biologics and combination products be used according to its labeling of approved (or “on- label”) uses. Oftentimes, however, doctors end up using products for “off-label” use. With this FDA requirement, how is it that doctors are able to use these products for unapproved uses? Read more »

Establishing Control Over the Quality of Your Biologic

When it comes to creating any form of medication, reputation is everything. Customers expect their medicine to have the correct ingredients, to be safe, and to work as described, with limited side effects. Should a medication fail to live up to those expectations, a company’s reputation could be at stake, and an entire product line might be scrapped due to concerns over efficacy or safety. Read more »

Delays in Biomanufacturing: What’s at the root of the problem?

Biomanufacturing is a difficult process, as anyone who works in the field understands, and there continues to be a great need for the work of biomanufacturing to become less expensive, more streamlined, and all around less problematic for biologics manufacturing companies. Understanding why biomanufacturing is so difficult and getting to the root of the problem can help change the process for the better and make it much more reliable for your company. Read more »