Validated Biosystems Consulting Services

My name is Pete Gagnon (rhymes with canyon). Everyone calls me Pete. Many of you know me, or know me though my writing, and you know that I’m not just the chief consultant at Validated Biosystems, I’m the only consultant at Validated Biosystems. So rather than coolly describing Validated Biosystems services in third person, I’m going to share what I can do for you on a personal basis.

[Process Development] [Advisory Consulting] [Applications Development] [Venture Opportunities] [Downstream Library] [Availability]

My entire professional career has been dedicated to developing bulletproof downstream manufacturing procedures—procedures that are rapid, economical, and virtually immune to external process variation. Over the past 20 years, I have consulted with more than 50 biopharma companies worldwide, ranging from start-ups to multinational giants. These companies include nearly every major manufacturer of purification products, whom I’ve mostly helped to develop applications, educational literature, and seminars so that users can get the most benefit from their products. However the majority of my work has been with manufacturers of human therapeutics. I have developed commercial purification procedures for hundreds of monoclonal antibodies and fusion proteins, peptide hormones, clotting factors, cytokines, plasmids, and virus particles. I have developed manufacturing procedures for immunoconjugates with enzymes, fluorescent proteins, cytotoxins, and PEG, and I have helped develop formulations for some of the industry’s most uncooperative products. This experience is the foundation for the services I offer.

Hands-on process development
Hands-on process development has been the hallmark of my consulting career. To my knowledge, I’m the only consultant in the industry who provides this kind of service. You may be thinking that it sounds expensive but I guarantee that I can help you put a solid process in place much faster than you’d think possible, and that it will hold up with nothing more than refinements on its odyssey through clinical trials and licensure. That in itself will save you a small fortune, even if the development process is straightforward. It will save you a big fortune if your product happens to have special characteristics.

I do most process development in my clients’ facilities. This has partly to do with material control, but it also provides an outstanding learning opportunity for your staff. When I come in to do a job, it is my goal to make myself obsolete as fast as possible by teaching you everything I have to offer on the subject. This can be a major asset if you're just putting your development group together. If you don’t have your facilities on line yet, I have my own, where I can take your cell culture supe and give you back purified product along with a process that you can put to immediate use for producing clinical material. I can also put you in touch with a reliable CMO if you anticipate needing production/purification services for some period of time.

[Process Development] [Advisory Consulting] [Applications Development] [Venture Opportunities] [Downstream Library] [Availability] [Top]

Advisory consulting
My hands-on work as a practical problem solver demands not only that I stay current with the latest tools in downstream processing but that I know where the field is going. I frequently do beta testing for emerging products, I’m a reviewer and editorial advisor for several journals, and I annually attend many conferences worldwide. All of these activities help me stay integrated with the industry’s evolution, and in combination with my lab experience, give me a solid platform to offer practical advice on solving a particular technical problem, assessing how your development or manufacturing program stands in relation to the industry, or helping you to start bringing the next generation of capabilities into your program now.

Courses in Downstream processing
I have been teaching courses in practical downstream processing for nearly 20 years, and they are great courses. The Flagship course is Bulletproof Purification Process Development. This is a 3-day intensive that emphasizes either protein or virus purification, according to your needs. Beginners, administrators, and regulators will learn a lot from this course, but folks with intermediate purification skills will get the most out of it. I also teach a 2-day course addressing purification of monoclonal antibodies. I also develop customized training courses covering whatever subset of purification or conjugation technology you would like to have addressed. If you would like me to teach any of these courses at your company, I will be happy to do so. If you would prefer that I offer a session in the Bahamas, Seychelles, or Phuket, let’s talk.

[Process Development] [Advisory Consulting] [Applications Development] [Venture Opportunities] [Downstream Library] [Availability] [Top]

Application development for new purification tools
I mostly do beta testing of new products gratis, simply because I appreciate the opportunity to have my hands on the hottest new prospects for downstream processing, but I also do more in depth application development work that leads to symposium presentations, journal publications, applications literature, and instructional materials. I have access to a wide variety of authentic samples so that I can put a new product through its paces under real-world conditions. If you plan to introduce a purification tool that you think is going to advance the field of downstream processing, it would be my pleasure to help you give it its best opportunity to succeed.

Assessment of Venture Opportunities
If you are a venture capital firm trying to decide if an opportunity is everything you hope, I can help you make that determination objectively. I can help you appreciate how it fits with the current state, needs, and evolutionary trends of the industry. I can also help you determine what it will take to bring that technology to market, and how well the technical team is matched to the task.

[Process Development] [Advisory Consulting] [Applications Development] [Venture Opportunities] [Downstream Library] [Availability] [Top]

On-Line Downstream Processing Library
You are probably familiar already with our Downstream Processing Library. I post various resources, including articles, presentations, and posters, all of which address practical issues in downstream processing. You are welcome to download anything you please for your individual personal use. The library is updated any time I have something new to post. Not all of the journals we publish in permit us to post electronic reprints, but you can at least obtain the citations to help track them down.

Availability for Consulting Projects
If you can fulfill your needs by consulting our Library, great—that’s what its there for. If the Library can’t take you as far as you need to go, I invite you to contact me directly so that we can discuss your goals. I usually have consulting engagements scheduled 3-6 months ahead on my calendar. That doesn’t mean that I’m booked solid; there are always openings and projects get rescheduled; but it does mean that if you’re considering having me work with you, it's a good idea to open a dialog as soon as possible. We can start with your confidentiality agreement and take it step by step from there. The best way to reach me is by e-mail but you’re welcome to phone me as well, whatever works best for you. I’ll look forward to hearing from you.

[Process Development] [Advisory Consulting] [Applications Development] [Venture Opportunities] [Downstream Library] [Availability] [Top]

Validated Biosystems Resource Guide for Downstream Processing
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