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    Date submitted
  • 28-Oct-2017

MicronView,LLC

Abstract

Germs are everywhere and that’s not usually a problem. However, companies making medicines or processing food under FDA oversight must be able to keep their production environment clean and monitor it to prove it. The FDA requires monitoring of all microbes including bacteria, yeast and mold. For some pharmaceutical processes the FDA requires monitoring clean rooms to insure there is no more than one microbe per cubic meter of air. Existing methods of monitoring take days, but modern technology can monitor the environment in real-time, minimizing the risks of losing millions of dollars of scrapped product and severe blows to company reputation and even loss of consumer lives.

Using fast optical technology and sotware analytics MicronView’s (MV) BioAerosol Monitoring System (BAMS) meets the real-time need for monitoring airborne microbes. BAMS is the most accurate, lowest cost, most compact and portable solution available. It is also already in production. There are forty thousand production workstations in the biopharma and medical device industries alone that should be monitored in real-time. That is a $2.5 billion global, addressable market which is now adopting real-time technology.

Additional Questions

Who is your customer?

MicronView's primary customers are the 100 major biopharma companies worldwide who make injectable drugs. The FDA requires monitoring of airborne microbes (bacteria, yeast, and mold) in biopharma factories. The current, or compendial, method for monitoring microbes in air takes 1-14 days for results. MV has first-hand knowledge that management at Roche, Pfizer and Amgen - at least - have mandated real-time microbial monitoring. MV has already completed its first testing of BAMS at Pfizer and Roche to compete hundreds of units in their deployment plans. The MV team also has excellent relationships with Baxter, Bayer, Eli Lilly, J&J, Merck and Novartis, having previously sold real-time microbial monitors to early adopters in these companies. A critical need of biopharma companies is to maintain real-time control of all of their clean rooms. In this space, Pfizer has confirmed a primary application for BAMS as a portable investigation tool, identifying clean room contamination location/source(s). Pfizer also estimates that these rapid investigations save nearly a year’s worth of manufacturing production capacity. To quote Pfizer, BAMS’ “portable investigation is awesome. The size and weight are phenomenal [and] the battery pack sets [BAMS] apart.” Another critical need of biopharma companies is to maintain real-time control of isolators in their Class-A clean rooms for manufacturing injectable drugs. They need to maintain less than one microbe per cubic meter of air in the isolators. Roche confirmed BAMS’ application here. In fact, Roche was so impressed with BAMS, they are recommending BAMS to Novartis. Of note, Pfizer indicates that they alone need over 1,000 monitors for each of their aseptic filling stations. Jeffrey Weber of Pfizer states that "Bio-Fluorescent Particle Counting [ like BAMS] provides continuous microbial monitoring for aseptic manufacturing which supports next generation manufacturing ...”. MV has first-hand knowledge that management at Roche, Pfizer and Amgen - at least - have mandated real-time microbial monitoring. MV has already completed its first testing of BAMS at Pfizer and Roche and is competing with TSI to supply both companies hundreds of units in their deployment plans. The MV team also has excellent relationships with Baxter, Bayer, Eli Lilly, J&J, Merck and Novartis, having previously sold real-time microbial monitors to early adopters in these companies.

What problem does this idea/product solve or what market need does it serve?

The FDA requires monitoring of airborne microbes (bacteria, yeast, and mold) in biopharma factories. The current, or compendial, method for monitoring microbes in air takes 1-14 days for results. A critical need of biopharma companies is to maintain real-time control of all of their clean rooms. In this space, Pfizer has confirmed a primary application for BAMS as a portable investigation tool, identifying clean room contamination location/source(s). Pfizer also estimates that these rapid investigations save nearly a year’s worth of manufacturing production at a single plant. To quote Pfizer, BAMS’ “portable investigation is awesome. The size and weight are phenomenal [and] the battery pack sets [BAMS] apart.” Another critical need of biopharma companies is to maintain real-time control of isolators in their Class-A clean rooms for manufacturing injectable drugs. They need to maintain less than one microbe per cubic meter of air in the isolators. Roche confirmed BAMS’ application here. In fact, Roche was so impressed with BAMS, they are recommending BAMS to Novartis. Of note, Pfizer indicates that they alone need over 1,000 monitors for each of their aseptic filling stations. Jeffrey Weber of Pfizer states that "Bio-Fluorescent Particle Counting [ like BAMS] provides continuous microbial monitoring for aseptic manufacturing which supports next generation manufacturing ...”.

What attributes will make this idea/product successful? Why do you believe that those features will create success?

BAMS integrates opto-electronic hardware with user-oriented software. It detects single microbial cells, providing test results instantaneously using laser-induced auto-fluorescence. It operates continuously like a smoke detector, with no chemical reagents or human interaction. It is also 100% efficient, which means that it sees all microbes that pass through it at 5 liters per minute. This efficiency and flow rate make it ideal for monitoring Class-A clean rooms that have extremely sensitive, laminar air flow designs. BAMS is also an ISO-certified particle counter. Weighing just 20 lbs., BAMS is just 50% the size of the only competitive instrument on the market, the TSI BioTrak. BAMS’ size allows it to even fit within production isolators, a huge advantage over the BioTrak and a desired feature of customers. With a large, 8-inch touch screen and combination AC-power/4-hour battery, BAMS is the only truly portable monitor, easily carried by hand. Technically, there are three real-time, airborne microbial monitoring products on the market. AZBIL/BioVigilant has the IMD, Particle Measuring Systems (PMS) the BioLaz, and TSI the BioTrak. BioVigilant is expending little sales effort on its 2009-vintage IMD. The IMD is expensive, requires an external monitor and is not portable - except on a cart. PMS has also already stopped selling its 2011-acquired Biolaz due to unforeseen design limits and resulting poor performance. TSI is the strongest current competitor, but, its 2011-vintage BioTrak uses an air concentrator and has limited accuracy. In fact, it loses up to 90% of critical microbial counts below 2.0um. In addition, at $70K-$80K/unit, the BioTrak is at least 30% more expensive than BAMS. Finally, the BioTrak is only portable on a cart, and – at twice the size of BAMS – is too large to fit in production isolators. MV employs a development team in China, providing competitive development and production cost advantages. While BAMS’ patent applications are pending in the U.S., China, and other international countries, BAMS is in production. MV is discreetly pursuing the top 20 global biopharma companies to establish global brand recognition and dominance as the

Explain how you (your team) will execute to make this idea/product successful? What gives you (your team) an advantage over others already in the market or new to this market?

With BAMS priced at $50K/unit and $10K in additional service revenues per year, customers calculate that BAMS: • Can reduce compendial testing volumes and associated personnel costs • Can reduce operating costs for airborne microbial monitoring by more than 50% • Pays for itself in 3 to 9 months of operation. The ongoing economic benefit to a biopharma company is extremely compelling. Of note, Bayer also reported that a single 8-hour production shift of a biotech drug for hemophilia is valued at $1 million. With two daily production shifts over seven days, $14 million could be scrapped if microbial contamination occurs - typically once a year at Bayer. Using BAMS’ real-time microbial detection, however, customers can immediately recognize contamination, stop production, and find/fix the problems. In addition, a wholesale $30K price allows distributors a 40% margin. The scalability of sales is evidenced at Amgen where sales went from 3 to 40 over a 12 month period - with MV’s founders’ last venture in waterbourne microbial testing. A similar pattern will exist for MV with the same or similar biopharma customers. MV management has mitigated many risks: 1) Recruited a strong, experienced management team 2) Filed international patents 3) Completed BAMS development and initial testing 4) Validated BAMS pilot manufacturing and field support capability Future milestones: 1) secure P.O.s from Roche and Pfizer as well as select smaller, more agile Biotech buyers 2) complete initial seed round of $1.5 million 3) complete Sales and Service staffing and distributor agreements 4) sell 24 BAMS units in 2018