Growth and expansion.
In any industry these two attributes are something that companies aspire to and are clear evidence of a healthy company. And indeed, these two fundamental tenants of business are what successful companies use as the basic building blocks for future success.
For the pharmaceutical industry – the recent past has been anything but a time of growth and expansion – mergers, acquisitions, and downsizing have all taken their toll on the industry. For companies to grow and prosper they have to look toward the future while also keeping a watchful eye on their current business to provide the quality of services their customers demand.
In the analytical services portion of the pharmaceutical industry, Impact Analytical, based in Midland, Michigan has shown a commitment to quality and to its customers that has offered it the opportunity to grow and to serve many industries.
Impact Analytical is a division of Michigan Molecular Institute (MMI) which was started in 1963 as a provider of contract R&D services to the polymer industry. According to Eric Hill, Impact Analytical’s Business Manager, the idea back then was to create a research center in the Midwest to compete with the big research companies on both coasts. “The idea,” he says, “was to create a critical mass of polymer technology and research in the Midwest.”
Over the years as the institute developed and grew, a lot of analytical capability was developed. In 1996 the CEO at the time decided to take the MMI analytical services group and turn it into a revenue-generating unit that could stand on its own. That service started doing external testing and Impact Analytical was created.
“The first customers were plastic manufacturers doing plastic testing and then chemical testing grew out of that,” says Hill. “I came on in 1999 worked in the lab – then in 2004 – started doing marketing and sales. In 2004 a new president was hired and the plan was to really grow the company into a true for profit external testing company.”
Hill continues, “We then expanded our testing capabilities to include other industries such as medical device, specialty chemicals, consumer products and pharmaceutical – today pharmaceutical is about 35 to 40 percent of our business.”
All of Impact’s labs are cGMP registered and all equipment is cGMP qualified. “We are now focusing on pharmaceuticals but will continue to be diversified across multiple industries,” says Hill. “Our primary focus in the near future is medical devices, pharmaceutical and consumer products – not necessarily in that order, but those are the industries we are focusing on. Plastic and chemicals will alway be a big part of our business considering where we are located.”
Scope of Services and Operational Strategies
For an analytical services company like Impact Analytical the importance of providing the right services with the most advanced technology is key to their success. In addition to the technology, the importance of having the best operational and quality control systems in place goes hand in hand to provide the best service to their customers.
Regarding the impact of technology on their service offerings, Hill points to the issues of throughput and detection. “Throughput is very important – there are now larger and faster autosamplers. For example, take a look at technology like fast GC or UPLC. With UPLC you can take an HPLC separation which typically will take 25 to 40 minutes to run and with broad peaks and you can now shrink that down to a 5 minute run, with very sharp peaks and better detection and which uses less solvent – its all around better. We’ve invested very heavily in this technology and going forward it will all be UPLC.”
The instrument lab features all new equipment including the
latest UPLC equipment designed to reduce run times, provide
sharper peaks, better detection and use less solvent.
Backing up the state-of the-art equipment are very robust quality control systems. As Hill explains, “We have a full-time quality manager and a very robust quality system in place. Because we operate in various industries our quality systems need to strong. Our base quality system is ISO 9001. Above that we offer layers of GLP, GMP and DEA licenses."
"We can have one lab that offers ISO level quality and right next to it one that offers GMP-level quality.”
“While the testing may be exactly the same as far as what we are doing in the lab, the documentation behind that is huge, as are safety controls. We also have to have a very robust training system for people to operate in both modes and still ensure quality.”
In addition to compliance scrutiny from agencies like the FDA, pharmaceutical service companies like Impact Analytical are also seeing increased scrutiny from the customer side.
“From the customer we see more scrutiny – because they are outsourcing more,” says Hill. “If a company wants to contract with us they need to have the confidence that we will deliver on all the timelines, costs, but most importantly – the quality.”
“Recently, we have been seeing more people coming to us saying ‘we have developed this drug candidate but we want you to do all the analytical work from method development to validation to release testing – all the way through’. That’s a bigger relationship than we have seen in the past and it all centers on trust.”
“Outsourcing is a preferred mode for the pharmaceutical industry and our forecasts show 3 - 4 years of increased outsourcing,” says Hill.
Moving on Out
The success of Impact Analytical has resulted in a happy problem - they have run out of space in their existing facility.
The company is currently in the process of fitting out its new facility and expects to have it fully functional in a matter of weeks.
“Growth is where it's at right now,” says Hill. “In our old facility we had 7,000 SF and were truly cramped for space.” To alleviate this problem Hill went before the company’s Board and explained how, in order to keep growing and to continue to provide quality services, the company needed more room.
His efforts paid off. “We purchased a building in Midland - more than double the size of our current facility. It was a 17,000 sf warehouse with just admin areas – an open space. We gutted the admin areas and built brand new lab areas.”
In addition to the “givens” such as administrative, sales and meeting areas, the new facility features two main lab areas – a sample prep lab and an instrument lab. The basic idea behind this arrangement might seem fairly obvious - put all the instruments in one area and all the sample prep in another – but lab design, instrument placement and safety all played a part.
“The idea is, number one, to make the instruments tools for the employees versus the employees owning an “instrument” - we don’t want that,” says Hill. “We want the instruments to be tools for everyone that is qualified to use them to make everything more efficient. You can shift resources around based on the work – eliminating bottlenecks.”
“There is also a safety issue,” he continues. “The prep lab handles all the sample prep work and has all the safety equipment installed such as hoods, sinks, eye showers, etc. Once samples are prepared – they are put in vials and brought to the instrument lab. This procedure keeps the sample prep area away from the instruments, helping to prevent instrument contamination and any damage.”
The sample prep lab is separate from the instrument lab to
eliminate contamination and any possibility of instrument damage.
“The other thing is that it will allow us to take advantage of all of the latest software that is available from the instrument manufacturers to allow remote access to instruments. We want the analysts out of the lab once the samples are running and in their offices interpreting the data and writing reports," says Hill. “The idea is to let the analysts control the instrument and download the data from their office and not from in the lab – this increases safety, reduce congestion, and cuts down the number of computers running instruments - because multiple instruments can be run from one computer, saving costs and also IT processing.”
Hill goes on to explain that the facility is also implementing a new Microsoft Dynamics CRM/ERP system which will run the CRM system, a LIMS system and their accounting software. “That software will team all of our software together and give us tenfold functionality,” says Hill. “It will do all of our ordering, invoicing, chemical ordering, chemical tracking and cost analysis.”
Impact Analytical's new instrument lab features equipment
that allows analysts to spend less time operating instruments
and more time analyzing data.
“The remote control of instruments is what we are really looking forward to - to enhance our service and efficiency for our customers.”
"Next year – we will begin looking at other opportunities specifically in the pharma space,” says Hill, “perhaps adding biologicals capabilities. We need to evaluate those opportunities – we will have the space in our new facility for adding capacity – and we will also have to evaluate the need for additional staff as the new capabilities come on-line.”
“Our value proposition is that we are a total service provider,” says Hill, “that’s where we try to fit in. Our niche is chemical analysis, but the other niche that we fit is that we have 25 people - we are going to try and retain the feel of a small and flexible company. Service is the big differentiator here. When a company comes through the door we match them up with our people. It’s literally scientists talking to scientists. We want them to feel like they are talking to a colleague. This forms a more efficient relationship and results in better overall service."