Manufacturing Q&A: Eden Biodesign
pharmafile | July 20, 2010 | Feature | Business Services, Manufacturing and Production |Â Â Eden Biodesign, careers, manufacturingÂ
How long has your company been operating?
Eden Biodesign is enjoying its tenth anniversary this year.
How is your field changing?
As a biopharmaceutical contract manufacturer we are seeing a much wider range of product types and technologies than we did five and ten years ago. This is driven in part by the tremendous advances in development of novel vaccines, both prophylactic and therapeutic, but we have also seen increasing sophistication in the development of monoclonal antibodies and recombinant proteins.
The processes that we execute are becoming more efficient and productive, meaning that it is more likely that production of products for later stage clinical development and commercial launch will be undertaken in facilities with smaller scale bioreactors and fermenters. There are also some remarkable developments in the way that we purify these products and the broad acceptance of disposable production technologies are facilitating efficient facility turnover and technology transfer.
The development of a wide range of ‘biosimilar’ and ‘biobetter’ products is also starting to have a significant impact in our marketplace and these products are already starting to utilise an increasing percentage of the available production capacity at contract manufacturers.
Our client base has diversified geographically – we now have clients in six of the seven continents. It is also clear that even the largest pharmaceutical players are now committed to outsourcing various aspects of their development activities and the clients for our services now include major multinationals as well as the more traditional emerging and mid-sized biotechnology companies.
In general, our client base has also become much more sophisticated in their understanding of what is required to take a biopharmaceutical product ‘from gene to clinic’.
Finally, we are seeing much closer relationships developing between service providers and their clients and the traditional fee-for-service model is being challenged as a wide range of creative business relationships and alliances is emerging.
What are the most enjoyable things about your work field?
I am responsible for Eden Biodesign’s global business development activities. Not only do I get to witness first hand many of the amazing product developments that are taking place in both the therapeutic and vaccine areas, but I also get to interact with opinion leaders, collaborators, clients and potential customers all over the world.
We also have a vibrant and enthusiastic team at Eden Biodesign that thrives in a dynamic marketplace with a seemingly never-ending series of new challenges and opportunities. I really do enjoy and appreciate my colleagues!
And the least enjoyable?
Having to gently let a potential customer know that their timelines or budgets are unrealistic.
What are the most common misconceptions about your field and the people who work within it?
That’s an interesting question. I have been in this business for a long time now and have previously worked for some of the largest multinational contract manufacturing organisations.
Some years back there may have been a perception that contract manufacturing organisations (CMOs) and their staff were somewhat ‘second class citizens’ when it came to drug development when, in fact, nothing could be further from the truth. Scientists, engineers and manufacturing staff in CMOs have the advantage of seeing a tremendous range of different product types and manufacturing technologies. Not only that, but we often see some of the more difficult projects from a technical perspective. This misconception has passed as CMOs have become recognised as a vital resource and a frequent means to cost-effectively accelerate development while preserving valuable capital. I’m sure that there continues to be other misconceptions, but perhaps this question is better asked of our clients!
What does your company offer that other competitors don’t?
Eden Biodesign is unusual in that, as one of a group of relatively new CMOs that has emerged in the last few years, we offer an unusually deep and wide service offering from mammalian cell line and microbial strain development, through to cell banking, process development and cGMP manufacturing. In particular, we are unusual as we provide cGMP production services for viral products in support of the development of viral vaccines and gene therapy products.
In addition to an inspected world class custom-designed multi product facility, I believe that another key differentiating factor is that our executive team and key managers have tremendous experience not only in process development and manufacturing, but also in wider product development for biopharmaceuticals.
By bringing this collective experience to bear, we are able to ‘begin with the end in mind’ and frequently assist our clients in ways that they hadn’t envisioned when selecting Eden Biodesign as their preferred service provider.
Being an independent operating company but wholly owned by Watson Pharmaceuticals (NYSE: WPI) we are able to offer our clients with significant security via our strong financial backing.
If you had advice for anyone starting out in your field now, what would it be?
Understand where you are going and how long it is going to take to get there. There are some pretty significant barriers to entry, including the high level of capital investment and long timelines for the design, construction and validation of cGMP facilities. Even once your facility is on line it will take a while to build a strong track record and earn the trust of the marketplace.
Also, stainless steel tanks and disposable bioreactors don’t run themselves! This is still a ‘people business’ and you are going to need access to world class talent!
What is the secret to a happy working life?
Wow! In today’s global marketplace a good ‘work life balance’ and strong family support system is extremely important. For me, having absolute confidence in the services that I am offering and colleagues that are talented, trustworthy and, yes, fun certainly also helps!
Roger Lias is the president and group commercial director for Eden Biodesign. For further information visit: www.edenbiodesign.com
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