bioproduction – BioProcessing Journal

From the Editor-in-Chief: Where’s the Value in These Never-Ending M&As?

I’ve seen little to tell me the major biopharma firms, or the larger supply firms, have learned anything. They’re stuck on the concepts of slashing vital resources—such as R&D and capacity—to “do deals” plus pay executive
bonuses, investment bankers, and hordes of attorneys. As a result, we’ve seen a burgeoning of Business-to-Business (B2B) meetings where the talks are geared toward selling companies and acquisition services. So we continue to see these large firms hoarding cash, acquiring companies, and cutting strategic resources…

Biologics Production

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From the Editor-in-Chief: I Still Don’t Like Calling Biopharmaceuticals “Drugs”

When I go to a therapeutic protein meeting, it’s very hard for me to hear these products referred to as “drugs.” But since they are being regulated by CDER, it’s a little easier to swallow. However, calling viral gene vectors and cellular therapies “drugs” is a bridge too far. My advice to my good friends at CBER is to keep calling their products “biologics,” or they may lose all of their regulatory responsibilities to CDER…

Biologics Production

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From the Editor-in-Chief: Many of the Toughest Biologicals are Becoming Easier to Produce

There are so many exciting things happening in the biotech industry. As we have all seen, antibody products are being approved for more and more cancer applications, in addition to those for auto-immune diseases, which used to dominate how they were being used. And of course, these applications are in addition to the many which use antibodies conjugated to chemotherapeutic drugs and imaging agents—where the antibody acts as a targeting mechanism. Then there are the hundreds of monoclonal and polyclonal antibody applications that have dominated diagnostic testing for decades…

Biologics Production

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From the Editor-in-Chief: Production Technology for Lentiviral Vectors

I’ve had some very interesting technical issues cross my desk in the last month, and one involves the “state-of-the-art” production technology for lentiviral vectors. And while you’d think this process should be quite advanced since the industry has been manufacturing viral gene vectors for over 20 years, it appears that we’ve fallen back on old technology and we’re dealing with processing issues we would typically avoid…

Biologics Production

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From the Editor-in-Chief: Major Successes in the Industry and Primary Challenges That Follow

As biologics continue to advance at a dizzying pace, I want to take this opportunity to outline what I see as the major successes, as well as the primary challenges facing the industry. First, the science of antibody production appears to be quite settled. Significant value can be gained by finding ways to limit production batches to volumes that can be accommodated by single-use bioreactor systems…

Biologics Production

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From the Editor-in-Chief: A “Renaissance” of Sorts Within the Biologics Industry

We just completed our 6th ISBioTech Spring Meeting, and it was a resounding success. And while the attendee numbers were up considerably, the more important aspects for me were that we had the “right” people, plus incredibly valuable content. Then what impressed me the most was the happiness and hopefulness I saw during the meals, receptions, and the banquet. We’ve been organizing these meetings for over 20 years, and I haven’t experienced anything like this since our earliest days in Williamsburg…

Biologics Production

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From the Editor-in-Chief: Biomedical Research and Biopharmaceutical Advances in Cuba

European organizations have been doing business with Cuba during its last 30 years of biotechnology development, and have benefited from both licensing and distribution agreements for generic pharmaceuticals, as well as vaccines and other biologicals. However, as far as direct US/Cuban interactions, we’ll probably have to go through a period of “low-level” scientific exchanges before there is much interaction. As a starting point, it has been proposed by the American Association for the Advancement of Science (AAAS) that an official scientific and technology agreement be established to form a broader framework for interactions…

Biologics Production

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From the Editor-in-Chief: Good News! The Licensure of Biologics is Really Taking Off

The licensure of biologics is really taking off as we all hoped it would in the ‘90s. There are a number of key factors including the advanced ability to produce adeno-associated virus (AAV) with baculovirus expression technology (BET), as well as the ability of BET to produce antigens that can successfully be used as vaccines. Then of course, there is the first licensed human gene therapy from uniQure, which is based on AAV-1 that was derived from BET…

Biologics Production

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From the Editor-in-Chief: Applying More Automation to Our BioProcessing

As an industry, we need to do far more to implement technologies and work with FDA, not only to keep them informed, but to make sure they are aware of industry trends and newer technologies. Remember that CBER and
CDER have their own labs, and in many cases, they will want to bring in the technologies you want to use and see how they work in their own experiments…

Biologics Production

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From the Editor-in-Chief: The Biotech Industry Continues to Improve

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

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