Biologics Production – Page 3 – BioProcessing Journal

From the Editor-in-Chief: “Therapeutic Glyco-Proteins Produced by Living Organisms” or “Drugs”?

“But why are they calling these products ‘drugs?’” I asked at the recent CMC Strategy meeting that CaSSS hosted in Gaithersburg. “Well it’s because they aren’t vaccines or blood products” said an old friend, who is an authority in the field. “But,” I said, “we’re really talking about therapeutic glyco-proteins produced by living organisms.” And just to make sure I was remembering things correctly, I searched Google and reviewed the definitions for a “biologic” and “biological” in several of the top technical references. Truly, a biologic or biological is a substance produced by a living organism, which would include glyco-proteins, non-glycosylated proteins, enzymes, viruses, and broken up proteins which could be used as poly-peptides or simple antigens…

Biologics Production

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From the Editor-in-Chief: The Beneficial “Spin-Out” Business Model

Consistent with our well-established format, this issue contains a very interesting collection of technical articles. However, we have stepped outside our normal content with a manuscript on the successful implementation of a “spin-out” company that was formed to develop a highly specialized technology. I’m hoping that this article by Dr. Charlotte Dyring (ExpreS2ion Biotechnologies) will provide inspiration to others who have envisioned a similar business model, plus trace a roadmap for organizations which have discovered that mergers and acquisitions aren’t giving them the products or sustainable growth they really need…

Biologics Production

biopharmaceuticals biotech industry business models expres2ion biotechnologies spin-out biotech sustainable growth

From the Editor-in-Chief: What Was Your Name Again?

The pace of M&As hasn’t slowed. It has become next to impossible to keep up with biotech company names, and some organizations can’t tell you what they are supposed to be called. I’m not exaggerating when I say that no one within some of these large organizations can tell you what name you should show in your database, what distinguishes their divisions, or what logo you should show as you give them credit for sponsoring an event or placing an ad…

Biologics Production

biopharmaceutical companies company name recognition mergers and acquisitions

From the Editor-in-Chief: Stem-to-Stern, Continuous Process for Biologics?

Call me jaded. One of the latest fads in the production of biologics is “continuous processing.” So let’s concede that the upstream realm can lend itself to continuous processing, but the really hard stuff was always on the downstream side. Here we’ve had to deal with product clarification and purification, which typically involve crossflow (tangential) filtration and chromatography run in a batch mode, with regeneration steps in between whatever was considered a batch…

Biologics Production

biologics biopharmaceuticals cell culture continuous bioprocessing continuous processing downstream process

From the Editor-in-Chief: The Best ROI — Employee Training and Career Development

I bet you are expecting me to rant and rave about M&A-focused business plans and how they are to blame for just about everything that is wrong with the biotech industry. Well, I guess I will a little, but I’m going to take a slightly different approach this time or you’ll probably quit reading my opinion pieces. So why not step back and look at this financial board game a little differently, where you consider employees to be a far better long-term investment than any company or technology you can buy?

Biologics Production

biologics biopharmaceuticals employee career development employee training m&a mergers and acquisitions return on investment roi staff training

From the Editor-in-Chief: Building Businesses and Developing Strategic Partnerships

Thankfully, recent market fluctuations have made M&As less attractive, and we can see more firms committed to building the businesses they already have, and developing strategic partners instead of acquisition targets. For this issue, I want to address the developments that may mean we are entering some lofty times in the biotech industry…

Biologics Production

biologics biopharmaceuticals building businesses entrepreneurship innovation m&a mergers and acquisitions r&d research and development small organizations strategic partnerships

From the Editor-in-Chief: Innovative Small Companies

While I could be deluding myself with wishful thinking, I may be seeing the “new normal” evolving for the biotech industry. The “new normal” may very well be that the mass closing of R&D facilities and the cancellation of major programs is freeing up the CSOs and other entrepreneurs who will start their own companies…

Biologics Production

biologics biopharmaceuticals entrepreneurship innovation m&a mergers and acquisitions r&d research and development small organizations

Beyond the Stainless Steel — The Real Capacity Crunch…

How do we ensure that the next generation of biotech medicines can be brought to market in a timely way, that they continue to be safe and effective and — of growing importance — are affordable by healthcare funding agencies, and profitable to the companies developing them?…

Biologics Production

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Viral and Prion Clearance Studies

A major concern for medicinal products of biological origin is the potential risk of contamination with known or unknown viruses. Manufacturers of biopharmaceutical products (such as recombinant proteins and monoclonal antibodies, or products derived from blood, tissue, or urine) are required to assess the ability of their manufacturing process to produce a product that is safe for use in humans…

Biologics Production

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Facility Design for Contract Manufacturing

The number of mammalian cell-culture based products is increasing rapidly and has the potential to out-pace the current production capacity. New facility construction for mammalian cell culture production is costly and time consuming. Planning for initial product launch and long-term commercial manufacturing can be daunting for promising products in late phase clinical trials…

Biologics Production

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Category: <span>Biologics Production</span>

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