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In The Right Place

Mon, 08/27/2012 - 12:02pm
Mike Auerbach, Editor In Chief

Predicting the future in the pharmaceuticals business is much like predicting the weather. You take all the available information you have and make an educated decision on what you think will happen in the future. If you are smart and savvy and know your business you increase your chances of not getting left outside in the rain without an umbrella.

Such is the case of AAIPharma a comprehensive pharmaceutical development and manufacturing services company based in Wilmington, NC.

By accurately looking at the direction the pharmaceutical contract services business was heading and through a program of smart investments in facilities, technology and technical expertise, AAIPharma has positioned itself to take full advantage of current and future market opportunities.

Background

AAIPharma has been in operation for over 30 years and in many different versions. At one time the company was a global clinical research firm and there was also a phase when the company had a product development group and was managing and marketing its own products.

According to Pat Walsh, the company’s CEO, through the various versions of the company the one piece that continually did well and showed growth was the analytical services piece.

In 2009 when the company was acquired by a health care private equity firm, the equity firm only purchased the analytical, formulation and manufacturing pieces of the company transforming it into a true standalone contract development and manufacturing business.

As Walsh points out, since then AAIPharma has seen a lot of growth. “Over the last few years there have been a number of changes in executive leadership and strategy to take advantage of outsourcing trends. We have put a significant amount of capital into the business: new buildings, lab equipment, new manufacturing suites, pilot plants, formulation lab, parenteral fill lines. It’s been a busy time.”

He continues, “We took a 3 year operating plan and did it in 18 months - consolidating the time lines. It’s been a lot of work for the team and management. The goal was to create a world class manufacturing facility and analytical lab to compete with anyone on a global basis.”

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AAIPharma's new analytical lab technology center offers a wide range of
services to the pharmaceutical industry.

The company’s Wilmington, NC location boasts a corporate office, a new analytical lab, the formulation team, central warehouse, clinical/commercial packaging, and an oral solid dosage manufacturing facility. In Charleston, SC the company has a parenteral facility which does liquid lyophilization and fill/finish. The company also offers two analytical labs that do material testing; one in St Louis, MO and another in Edison, NJ – which was part of the recent Celsis acquisition and another analytical lab in Durham, NC.

“When you look at all of that,” says Walsh, referring to his company’s wide array of facilities, “we can take a compound all the way through to commercialization if a client chooses that route.”

New Technology Center

The most recent example of AAIPharma’s commitment to serving the needs of the pharmaceutical industry is the opening of a brand new 40,000 square foot analytical lab technology center in Wilmington. The center, which houses analytical, microbiology, preformulation, and mass spectrometry experts, also received an infusion of new UPLC, HPLC, GC-MS, and LC-MS-MS systems to complement the company’s existing array of laboratory resources.

According to Walsh there were three primary reasons for constructing the new facility:

1.         The company wanted to centralize the lab facility in Wilmington for better turnaround times.

2.         AAIPharma was embarking on a process to go paperless – the company is one of the first labs in the world to go fully paperless and now offers electronic lab notebooks and on-line lab data for clients.

3.         The company looked at the infrastructures of the other buildings which were dated and it was time to upgrade and put everything in a single campus.

According to Dean Shirazi, Ph.D., Vice President, Analytical Development, the addition of this new facility allows the company the luxury of being able to identify trends and offer services to the pharmaceutical industry that other contract firms just can’t do. For example by September of 2013 new USP testing standards will force all pharmaceutical companies to do more tests for heavy metals in their products. “With our new equipment we can do this before others, “says Shirazi. “A lot of clients are coming to us now because they are concerned over the new USP testing standards - we are ahead of the curve.”

Chromatography is another area the company has invested in as Shirazi explains, “Chromatography has progressed immensely. Since particle size is getting smaller and smaller – increasing pressure – regular HPLC is too slow – new technology allows high pressure with these smaller particles. In 5 years everyone is going to need this technology - but we already have it.”

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AAIPharma has made a sizeable investment in UPLC, HPLC, GC-MS, and
LC-MS-MS systems.

Having the latest equipment is a definite advantage for AAIPharma, but they also have the methods and technical expertise, as Shirazi notes, “We have developed methods for this new technology as well – in addition to testing and validating methodologies. We have the knowledge and the equipment.’

“By using this new technology – we can get projects others can’t. We have the science and the equipment now.” Shirazi concludes.

“A lot small labs,” says Walsh, “if you need to buy capital equipment or hire experienced staff you can’t do it financially. We are looking at it as an opportunity because we have the scale, and the financial ability to invest. We are on the right side of the curve.”

Manufacturing and Packaging Services

In addition to their cutting edge analytical and formulation expertise, AAIPharma also offers a complete range of manufacturing and packaging facilities for sterile and oral solid dosage products.

At the company’s packaging facility in Wilmington the company offers:

• Commercial Packaging

• Clinical labeling, packaging and kitting

• Bottle packaging – manual and semi-automated

• Blisterpackaging

• Carding, multiple product CRC.

“We can do a wide array of packaging types, says Walsh. “We can customize anything; bottles, blisterpacks, etc.” And to keep up with demand and offer more flexibility the company is installing a new tablet/capsule filler which will increase bottle filling capacity from the current 10,000 bottles per shift to almost 30,000 per shift.

The company also boasts over 18,000 cubic feet of stability chamber space for stability testing of customer’s products. “Depending on where in the world a client is going to sell its products, they might have to test a product under certain conditions for up to 12 months. We have a full bank of stability chambers for every type of stability condition,” says Walsh.

Walsh continues, “Redundancies are built-in – if anything goes out there is a back-up. Its all set up on a monitoring system – to show every condition – and an automated call goes out in case of an emergency. Samples can also be stored at other locations, but the important point is that we have never lost a sample.”

The company’s oral solid dosage manufacturing facility, also in Wilmington is FDA and MHRA compliant and has extensive experience with a variety of oral solid dosage forms. The company can provide a wide range of products from clinical to commercial scale. Highlights include:

• Batch sizes ranging from 20g of API for Phase I powder in capsules on the Xcelodose to large scale commercial tablet batches up to 650kg.

• Accelerated process transfer expertise for advancing products to manufacture faster and reducing risk of inventory or market disruptions

• Dedicated process engineer and project coordinator

According to Walsh the parenteral market is growing and to keep pace with that growth the company is adding a second filling line at their Charleston, SC sterile manufacturing facility.

“The parenteral field is booming right now,” says Walsh. “We are adding a second fill line in our parenteral facility.’

He continues, ‘There is a higher level of regulatory scrutiny going on in that world (parenterals). Clients are looking for options and we have a good parenteral manufacturing track record.”

Indeed, to keep pace with industry standards and to be as responsive to client needs as possible, AAIPharma’s second fill line at its Charleston sterile manufacturing facility will be 100% disposable.

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AAIPharma is seeing a huge boom in manufacturing parenteral products.

The Importance of Technology

AAIPharma, through its investments in both its analytical and manufacturing/packaging facilities, has shown it is not adverse to keeping up to date with technology. To do this it has relied on the expertise and experience of many equipment vendors. Speaking on the importance of these vendors to the success of his company Walsh says “First and foremost, it’s important in that we have to keep pace with new technologies.”

The Future

“We are pretty excited about now and the future, “says Walsh. “Industry outsourcing trends show a substantial growth curve. The things that we do are most of the things that pharma and biotech companies are outsourcing. They are looking more and more to material testing companies to provide immediate and rapid turnaround. Our material testing centers provide the quickest turnaround in the industry.”

Even as the need for outsourcing providers grows, Walsh sees a certain amount of consolidation in the industry, although it hasn’t affected AAIPharma, ‘We think sponsor companies are going to look at consolidating vendors. We have seen, and this is no exaggeration, dozens of companies have come to us and provide us with their business plan, and every large pharma has mentioned that they are in the process of consolidating vendors and that there is a number they have settled on. AAI is always on the list – because we provide the services they rely on. We give the client a lot of flexibility.”

“We are also seeing a significant upgrade on the regulatory side,” says Walsh. “This is the first year we have seen the DEA come out and audit analytical labs nationwide. We have been audited numerous times – but this has become an industry issue – and it has forced many analytical labs to consider whether or not they want to continue their services. We have a strong track record.”

Walsh also sees AAIPharma as a global competitor. “We can compete with any company anywhere in the world, not only on a competitive scale but technologically. We can provide a client with on-line access and we have a scientific team here that is second to none – which has been one of our hallmarks for 30 years.”

And finally, in keeping with his desire to provide the best service to his customers Walsh says, “We are constantly on the lookout for any anything that can make us more efficient and lower turnaround times.”

 

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