Category: <span>Biologics Production</span>

It appears that the state of the biotech industry continues to improve. We now have a licensed cellular therapy that Dendreon developed, and which has now been sold to another firm that thinks it can make and administer this prostate cancer vaccine more efficiently, plus provide a more effective product. There is also a viral gene vector that has been licensed in Europe, and an application for US licensing has been submitted. Then there is the licensed influenza vaccine that is made with baculovirus technology, plus a second baculovirus-derived flu vaccine that is near licensure. The two companies with these flu vaccines are now charging ahead with their baculovirus expertise to produce Ebola vaccines…

Biologics Production

Today, thanks to the continued pace of M&As, there are fewer biotech companies, and the desired number of new products just hasn’t materialized. But the real travesty is the loss of the small companies that were creating so many of the highly skilled jobs, and providing the innovation that was driving much of the industry. And what happened to all the displaced workers? Instead of forming partnerships to capitalize on the benefits these small companies had to offer, the acquiring companies had to have it all, or nothing. And unfortunately, too many of them ended up with nothing…

Biologics Production

Regarding our current worldwide recession, cheap money and speculation not only hurt the investment and housing industries, but lead far too many organizations in the biotech industry to ignore their core businesses and focus on “growth through acquisition.” As we move into 2008, please help me encourage a return to the principles that built this biotech industry like: entrepreneurship, good science, strong relationships, and innovation. If your company wants to obtain a technology, make an investment or simply license the rights you want. But whatever you do, leave the small companies alone to do what they do best, and what made them attractive in the first place. The value of a company is seldom in its buildings, equipment, products, and IP. It’s in the goodwill that has been built through the value it offers, and the people who created this value…

Biologics Production

There are some encouraging signs concerning the economy. We’ll know that things are improving when the big firms start to spin off companies. And the best deals will be those in which the new owners are the people who are closest to the products and technologies. As part of the deal, the divesting firm could retain certain rights or options for technologies, manufacturing, and marketing. They could also retain a certain amount of ownership in what would now be small innovative firms with people devoted to the technologies, and they could lease unused facilities to these firms instead of giving them away to people who would tear them down. And still better, would be if they returned to the very successful model of providing milestone payments when critical development goals were met…

Biologics Production

In this BPJ issue, our feature article covers the 50-year history of Vero cells in vaccine applications. You’ll
also learn about trends in the characterization of complex biological products, heart valve preservation,
and patenting issues for single-use products. We also present the possibilities of bio-electrosprays and cell
electrospinning, along with considerations for disposable chromatography. And finally, this issue delves
into nanofiltration and the molecular diagnostics market. And I also want to discuss the fact that, in 2007, the U.S. federal government is continuing to starve the FDA of funding. It is time to fix this…

Biologics Production

Thank goodness for the new, smaller companies. They’re hungry for marketing opportunities and they are filling the void left by the “acquired companies.” Now the vast majority of our support comes from these smaller firms which have a short and simple decision-making process, and they buy our services because they see the value and enjoy doing business with us. What a concept!

Biologics Production

The industry continues to adopt more single-use, and limited multi-use, components and systems for process development and production operations. In addition, biotech firms are building and retrofitting their facilities so they will provide more flexibility when product priorities change and multiple products must be produced at the same time. In addition, these facilities must support products at various phases of clinical evaluation, plus when they are approved for licensed production…

Biologics Production

We were invited to visit Slovenia and cover a monolith chromatography course that BIA Separations holds every
two years during the summer. We arrived a week early with the intention of exploring the region and found a rich history, beautifully maintained roads, breathtaking scenery (ranging from the Alps to the Adriatic Sea), plus some of the most hospitable people I’ve ever encountered in international travel. The symposium program featured talks from all over the world, including a number of chromatography’s best known names. There was plenty of
chemistry and chromatographic technology to satisfy anyone in downstream processing…

Biologics Production

First, I’m still dying to learn what the regulations are that are keeping American businesses from expanding their operations and hiring people. We keep hearing that the government has to illuminate regulations that are killing jobs, but I just can’t determine what these are. Surely the biopharmaceutical industry isn’t suggesting that it regulate itself while asking the government to protect it from litigation if something goes wrong. And I can’t believe that workplace safety or child labor laws must be abolished. So in this regard, I’ll just have to keep searching until things make sense, or I find they were never meant to…

Biologics Production

There are many examples of efforts to make biosimilar products, such as every time a product is taken to a larger
scale, and when an established product is transferred to another facility, including a contract manufacturing site.
While most of these examples have resulted in products which were indistinguishable for all practical purposes,
others revealed troubling differences during product characterization or clinical administration…

Biologics Production