Blue Stream Laboratories
March 18, 2013 Issue
The Most Powerful Name In Corporate News and Information
With an Advanced Analytical Laboratory specializing in Recombinant Glycoprotein and Complex Biologics Characterization Services, CRO Blue Stream Laboratories is providing the necessary Analytical Tools to Speed the Development of Products for Virtual Biotechs to Fortune 500 Pharmaceutical and Medical Device Companies
About Blue Stream Laboratories:
Blue Stream Laboratories
is an advanced analytical laboratory specializing in recombinant
glycoprotein and complex biologics characterization services. Blue Stream
supports pre-IND through cGMP clinical phase product development programs
for product characterization, lot release, and stability programs. Located
in Cambridge and serving companies throughout the U.S. and overseas, Blue
Stream's clients range from small start-ups and virtual biotechs to Fortune
500 pharmaceutical and medical device companies.
Mario is Chief Scientific/Operating Officer and co-founder of Blue Stream Laboratories. Dr. DiPaola has over 20 years experience in the biotechnology/ pharmaceutical industry with extensive knowledge in basic research, development, quality, manufacturing and regulatory functions for protein and small molecule based pharmaceutical products; including a number of approved therapeutics: Alferon-N®, Amevive®, and Sucraid®. From 2001 through 2005, Dr. DiPaola held a variety of positions with Antigenics, including Senior Director of Manufacturing and Director of Quality Control. From 1998-2001, he served in the position of Project Leader at Biogen Idec and authored numerous CMC sections for European and U.S. regulatory filings (IND/BLA/CTD). Prior to his work at Biogen Idec, from 1990-1998, he served as Director of Analytical Development and Quality Control with Charles River Laboratories and Associate Director of Analytical Biochemistry with Interferon Sciences. Dr. DiPaola holds a Ph.D. in Biochemistry from New York University, and an M.B.A. in Finance from CUNY - Baruch College.
Interview conducted by: Lynn Fosse, Senior Editor, CEOCFO Magazine, Published – March 18, 2013
Dr. DiPaola: Blue Stream Laboratories is a contract research organization located in Cambridge, Massachusetts. It was founded in 2006 by three founders: Michael Kouchakdjian, Bill Rash, and myself. Since its inception, the company has continually grown, and we currently employ between twenty to twenty-five people. We anticipate being able to continue our growth trajectory or, more preferably, accelerate our growth over the course of the next few years.
CEOCFO: What was the plan when you founded the lab? What did you envision doing and how has that developed so far?
Dr. DiPaola: The three founders are very familiar with the pharmaceutical and biopharmaceutical industry and the service side of it. There had been the recognition by the three of us that there were some unmet needs within the contract research side of the industry where potentially an organization such as Blue Stream might be able to fill the gap and possibly be able to do reasonably well. This need at the time, in 2006, was related to the fact that while there were quite a number of contract research organizations (CROs) already spread throughout the country and overseas supporting mostly the small molecule development needs, none of these CROs possessed the in-depth analytical skills geared toward supporting biologics development, the area in which Blue Stream has focused. Therefore, we undertook the effort of putting together an organization to provide advanced analytical services that would service some of the unmet needs of the biotechnology/biopharmaceutical industry.
CEOCFO: How has the vision played out?
Dr. DiPaola: The vision has played out reasonably well. In fact, it has played out so well that now there is much more competition since there has been a recognition by other players of this unmet need. In fact many of the existing contract research organizations recognized that there was room for expansion into the analytical side in support of biopharmaceutical development, and they have done so. As a result, the field has gotten much more crowded than when we first got going about seven years ago.
CEOCFO: Can you explain what you do as far as analysis?
Dr. DiPaola: Blue Stream Laboratories focuses primarily in providing advanced analytical services to the biopharmaceutical industry. These services include mass spectroscopy for full characterization of glycoproteins, biophysical techniques to support secondary and tertiary structural characterization, along with the more conventional services of HPLC, electrophoresis, capillary electrophoresis, immunoassays and standard wet chemistry techniques. Blue Stream will assist a company needing our type of services in doing not only characterization of their protein-based molecule, but also in developing the necessary analytical tools to perform the release/stability testing of these products. These analytical tools will be used to release the product as the product evolves through the various clinical phases. Some of these analytical tools will also be utilized to evaluate the stability of the product. Based on our capabilities, Blue Stream can assist an organization not only at the early stages of product development, when the molecule being developed requires quite a bit of characterization, but then Blue Stream can also continue by performing the routine analysis and the stability assessment of the product at the clinical and post-clinical stages. In summary, because Blue Stream maintains its facilities in accordance with cGMP requirements, we can accompany a biologics developing entity from the early stage of development up to commercialization of their product.
CEOCFO: How did companies manage to accomplish this analysis before BlueStream?
Dr. DiPaola: Many companies about a decade ago would build expensive infrastructures and laboratories to support the development of their products. More lately, there has been an evolution in the industry whereby the outsourcing has become much more common. Small organizations do not need to really build this intricate and expensive infrastructure in order to develop their products as most of the development can be outsourced to organizations such as ours. This type of outsourcing has become also common among the Pharma companies, which instead of continuing to grow their scientific staff and acquire additional equipment and space, they are outsourcing more and more of their development so that they can maintain greater control of their R&D budgets.
CEOCFO: How do companies find out about you?
Dr. DiPaola: We have different means by making ourselves known. Clearly the internet plays a significant role. We have constructed a detailed and, hopefully user-friendly, website, which potential clients can search through to learn about Blue Stream and the services that we provide. We also have a very active sales team that will contact prospective clients and see if there is any interest or alignment between what we do and what their needs are. Thirdly is by participating in various industry conferences that are focused towards the type of services that we offer. These are the main modalities by which we make ourselves known to potential clients out there.
CEOCFO: Would you give us an example of something you were able to see that either helped a company go forward or caused them to stop in their tracks and reassess?
Dr. DiPaola: For virtual companies and small to mid-size organizations, what we do is provide the necessary analytical tools that can quickly speed the development of their products. While there may have been instances in which the data from our characterization/testing may have been unexpected and, thus, caused some slowdown. I do not believe that we have not run into a situation where we actually analyzed a product and we determined that the development of the product should be stopped outright. In many cases if there is an issue, it can be resolved. For example, if we analyze a product and we find that there is some impurity at a much higher level than a regulatory agency or the company itself would feel comfortable with, then the process or the means by which the product is produced can be redesigned in order to find ways to minimize such an impurity. As far as protein products, because one of the major services that we provide is based on mass spectroscopy, which allows for the intricate analysis of the product, from time to time we may run into a situation where we may find some modifications that were unexpected; but such a finding does not necessarily mean that it will stop the product in its track. It is just additional information available to the developer to weigh against product safety, efficacy and long term stability. All-in-all, I cannot think of any time when what we determined led a company to pull the plug on a particular product. On the other hand, over the past seven years we have assisted many Companies by performing the IND enabling chemistry portion of the CMC requirements which has then allowed these Companies to begin clinical evaluation of their molecules.
CEOCFO: Would you tell us about your cutting edge mass spectrometry methods?
Dr. DiPaola: Because some of our services are very mass spectrometry intensive, we have expanded our mass spectrometry capabilities so that we can provide more detailed analysis of the products that we test and with a faster turn-around. With our current mass spectroscopy capabilities, we can basically evaluate some of these products in much greater details so that we get a superior appreciation of the characteristics and intricacies of these products.
CEOCFO: Are you able to handle whatever volume of business is coming your way?
Dr. DiPaola: If the business volume were to rapidly double then we would likely be confronted with some capacity issues with respect to staffing and physical space. It is worth noting that since its inception, Blue Stream has managed contracts from as many as one hundred and fifty different companies.
CEOCFO: Why should investors and people in the business and healthcare communities pay attention to Blue Stream Laboratories?
DiPaola: We are in a very
interesting, exciting and quickly expanding area of the industry. The types
of services that we provide are well suited for the emerging field of
Biosimilars. This line of products is highly analytically intensive and
requires sophisticated methodologies such as what Blue Stream provides.
Furthermore, the outsourcing expansion due to greater participation in this
process by mid-to-large size biotech companies and large pharma has caused
an increase in demand of analytical services which directly benefits Blue
Stream labs. It is also worth mentioning that Blue Stream is one of the
first CROs to provide extensive biophysical services. These are very
sophisticated techniques used to understand the higher order structural
features of proteins. While in the past there have been a few small-sized
providers, typically staffed by a couple of scientists, providing these
types of services, many Companies needing this type of analysis had to rely
mostly on academic core centers. Blue Stream is now equipped and staffed to
support the biophysical needs of the industry.
“For virtual companies and small to mid-size organizations, what we do is provide the necessary analytical tools that can quickly speed the development of their products.”- Mario DiPaola
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