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Excellence Achieved

Tue, 01/14/2014 - 11:45am
Mike Auerbach, Editor in Chief

All companies seek excellence - excellence in their operations, excellence in their management, and excellence in their products.
In the pharmaceutical industry, and in particular the growing market for contract services and manufacturing, the resources needed to achieve excellence can get spread thin given the vast number of potential services and manufacturing options needed to test, develop and manufacture the growing number of pharmaceuticals available today.
But what if you were able to focus your resources and expertise on one specific area of pharmaceutical development? Would you be able to achieve excellence in that one area?
Tampa, Florida based CDMO Xcelience is a provider of preformulation, analytical, formulation development, manufacturing and clinical packaging solutions and distribution with an established reputation for accelerating project timelines. By focusing its resources, expertise and talent on these core competencies, Xcelience helps its clients reach critical milestones faster, deliver clinical materials on time, control costs, and above all ensure quality.

History, Background and Transition
Xcelience’s roots date back to 1997 when it was originally a part of a larger CRO that was a “one-stop” shop, offering everything from pharmacology studies to bioanalytical testing and even clinical trial beds.
In 2005, the parent company announced it was going to sell off some units and several managers from the company were able to put together a management buyout and form Xcelience. Derek Hennecke, the company’s president was part of the team that engineered the buyout and believes the company is much better off with its current focus.
“I’m a big believer that being a one-stop shop is a bad strategy because you can’t be everything to everybody and the strategy and execution is poor when you try to put all that together,” says Hennecke.
Hennecke says that the idea of having a one-stop shop might sound good on paper, but in reality there are many flaws with that idea. He says that because of the complexity of pieces that make up drug development testing and manufacturing, clients aren’t asking for all of them bundled together – what they are asking for is excellence in one area.
“There aren’t too many companies who are asking to go to a one-stop shop,” says Hennecke. “The idea is that the client will want to stay with you because you offer all the services they might need – sort of like selling French fries with a hamburger – but in my experience clients are not asking for that. Different people ask for different services. I haven’t found too many services that can be bundled up that way.”
“As a stand-alone entity focusing on one specialty we are able to concentrate on pharmaceutical development and clinical trial materials and have continued to grow.”

Service Offerings
Xcelience’s service offerings are bundled together in a logical manner designed to offer their clients the specific resources for drug development and clinical trials materials. Currently, Xcelience offers preformulation services; analytical services; formulation development; manufacturing, packaging and labeling; stability program management and distribution. (See sidebar for more details)
Xcelience’s capacities are focused on clinical trial size batches and Hennecke views this as a positive. “There is a lot of CMO capacity out there," says Hennecke. “Our clients are not asking us to have that large capacity – they want us to help them launch their smaller scale products with the expertise we can offer them.”
He continues, “We can get our clients to market quicker than the larger CMOS and we are also going to be more attentive and interested in their products than a large CMO. A large CMO wants millions of tablet a year to keep their presses running. We are happy with smaller runs and to be very integrated with our customers.”


Regarding dosage forms, Xcelience has focused its resources and expertise on solid and semi-solid products and liquid filling. “We have a wide variety of capabilities,” says Hennecke. “Tableting, granulation, coating, encapsulation, API in capsules, high-speed encapsulations, liquids and gels in capsules, lozenges, semi-solids, dispersions, liquid filling into bottles and tubes – we can do all of it.”
In order to provide its customers with the utmost in service and expertise, the company employs a number of cutting edge technologies in its facility. In particular, the company employs five Xcelodose capsule filling machines.
“We were the first CMO in the US to use the Xceledose for API in a capsule filling,“ says Hennecke. “In 2005 we were working with a small company in the UK developing this technology and we bought the first machine in this space. The Xcelodose eliminates the need to do any formulating at all and allows you to get an API in a capsule and then do your product development. It got us in the door early with large pharma clients. Our larger pharma clients saw this technology as a way to speed up their studies. It is now an accepted technology – but we have the most experiences with it and fill the largest amount of batches with this technology.”
“Since we now have the experience with the customers API we can come back with our analytical experience and results and develop the formulations and further Phase II and Phase III studies and, depending on the size, launch the product with them."
While Hennecke is very pleased with the capabilities of the Xcelodose machines and the benefits they give his clients he is also quick to point out the company is always interested in new technology. “We have a strong belief that we don’t want to have a proprietary or locked in closed system. We are privately funded and have no outside debt which mean we can put every dollar of profit back into the company - and keep buying more equipment and more capabilities.”
For analytical and developmental purposes the company offers a GeoPyc 1360 and a Pycnometer that measures the envelope density for roller compactors.
“We also have a ring-shear tester – a very expensive piece of equipment that will test the cohesiveness of the APIs and blends to help determine whether the blend being studied will create more sticking and picking on the tablet press,” says Hennecke.
“This tester ties in with QbD (Quality by Design) and DoE (Design of Experiments) – because we need quantitative results to show why one particular blend of 15 tested is better than the others.”
Having advanced equipment is an advantage for Xcelience and its customers as all testing can now be done in-house resulting in time and money saved.
Other analytical technologies in Xcelience’s facility include a rheometer for gel testing, thermographic analysis for API behavior, an  X-ray diffraction tester for crystals, titrators and wide variety of HPLCs.
“People are amazed that we have so much in one location,” says Hennecke.

Project Management
In the pharmaceutical contract business every project and every client is different and all have to be handled in a way that makes the client confident and comfortable with the service provider they choose.
According to Hennecke, Xcelience’s clients are fairly evenly divided between large pharma, specialty pharma and biotech or virtual companies. This varied client base has given the company the opportunity and experience to work with many different products and has resulted in a flexible company that can handle just about anything.
In particular, the biotech or “virtual” companies are a specialty for Xcelience, as Hennecke points out, ”With the biotech or virtual companies we have to take a very proactive project management approach to make sure we are handling the programs to make sure we know what they want to do with the molecule they are developing. We will propose things fit for today with an eye on the future. We do this to prepare for future analysis and make sure we can get everything aligned to meet the customer’s needs.”
“We are very good at understanding what companies are ultimately looking for,” he says.


For all projects that come to Xcelience each is assigned a project manager who stays with the project for its duration. This project manager understands the client’s needs and understands the project requirements best. Hennecke points out that it is Xcelience's job to make the project as easy as possible for the client and for it not be a burden. “We don’t want them (the client) to have to add personnel to manage the project and the CDMO – it kind of defeats the purpose of using a contract services organization.”

Inside the Facility
Xcelience actually has two facilities in Tampa, the Laurel Street facility is 24,000 sf and operates as the company main analytical, R&D and clinical trials manufacturing location; and the recently opened Grace Street facility, which is also 24,000 sf and has been purpose-built for primary and secondary packaging, and contains five secondary and four primary packaging rooms, in addition to labeling, warehouse and storage facilities.
The Laurel Street manufacturing facility features 10 manufacturing rooms, a significant increase from 2012 when the company only had 5 rooms. Now the company boasts six rooms for R&D work including areas for coating, drying, tablet pressing, and an instrumented tablet press which is very important for DoE and for QbD qualitative results. The other rooms in the Laurel street facility are devoted to analytical work and include the specialized instruments mentioned above.

Future
Thanks to the opening of Xcelience’s new Grace Street packaging facility, the company is looking forward to a lot of growth in that area.
“The biggest single part of our future lies in packaging and distribution,” says Hennecke. “People say they can do packaging – obviously you have to put the product in something – but we have gone after the clinical supply part – which is usually held as a separate service.”
“Mid-sized clients are surprised we offer these services,” says Hennecke. “They used to have to send their product to larger companies – not thinking a company of our size could offer these services.”
In addition to growing the packaging side of the business, Hennecke is also looking to expand internationally.
“Clinical trial needs and patient needs are growing. Many clinical trials are being conducted overseas because they need to have a diverse population to study."
“We are quite small but we have a lot to offer to the client,” says Hennecke.

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