Chesapeake Biological Laboratories

Source: Healthcare Digital

Date :31/10/2007 06:20:33

CBL invests in process improvement

Processing and packing drugs, Chesapeake Biological Services, Inc provides the last stage in an essential industry that is heavily regulated at every turn. It has to work hard and long to make the efficiency gains its clients want

Written by David Hughes and Produced by Thomas Venturo

Time to market is a vital element in the success of any industry, and especially in the highly competitive pharmaceutical sector. Competitive it may be but it is also the among the most highly regulated industries anywhere: where business runs up against bureaucracy, however necessary it is, delays and increased costs ensue.

In order to defray costs of all kinds, modern manufacturing practise calls for leanness and increased specialization: the result is an industry with a few extremely well resourced giants, who do everything from R&D through delivery of the final product, plus a great many smaller concerns that concentrate on their area of expertise. The further along the chain you are, however, the greater the number of others behind you applying both time and cost pressures. This is the experience of Chesapeake Biological Laboratories, Inc based in Baltimore, MD.

“In a way, we’re the underdog,” says the 12-year standing General Manager of CBL, Dr Vicki Wolff-Long. “Our business is providing fill-finish services for sterile injectable drugs. We don’t own any of the products we use, we just provide the service. This is the last step before the product goes into the clinic.”

Niche diseases

The company’s client list includes both large and small pharmaceutical manufacturers, many of them famous names, who have outsourced this final phase of production.

“These companies tend to use us for earlier phase products that are going into trials or indeed those in late-phase validation that they are looking to commercialize,” says Dr Wolff-Long. “Or they are expensive products that it is only viable to run in small batches – some clients don’t want to have a couple of million dollars of stock on their hands.”

What they all have in common are low volume product runs: “You won’t find a blockbuster drug in these labs but you will find those for niche diseases for a population that requires the drug every year.”

The company currently fills in the region of a million vials and pre-loaded syringes per year in batch runs of between about 2,000 and 20,000 that are then sent to distributors for nation- and world-wide dispatch. It has between 25 and 30 clients, a number that has grown steadily in the last five years or so, and deals with 14 commercial products.

CBL and the processes and equipment it uses, such as sterilization, filtration and lyophilization (essentially freeze drying), are subject to constant scrutiny and audit to ensure compliance with FDA standards.

Layout improvement

“We get audited at least once a week by our current clients, by potential clients and of course by the regulatory bodies,” says Wolff-Long. “But these are just the times we live in and you integrate it all into project management.”

An internal audit recently threw up a couple of bottle-necks in the production process, of them essential in meeting compliance standards: everything that goes into the clean room has to be sterilized, either in an autoclave or in depyrogenation oven, a stage that takes several hours. In order to improve capacity and expand throughput, CBL this year invested about half a million dollars in a second oven. “It was a big investment for us but it has allowed us to look at other areas of our GMP [Good Manufacturing Practice] area. Part of our current strategy is to rearrange that area to make it more efficient. For example over the past several years, and for historical reasons, we have a traffic jam with the lyophilization process in the filling room. The machine is essentially in the wrong place. So now we are working with our clients to improve the layout.”

It is not simply a case of moving machines to their optimal position, although that is the final goal. CBL has to jump through all sorts of hoops to ensure it and its equipment remain in compliance. But it doesn’t just have to satisfy its own regulator, it must also satisfy each and every one of its clients and their regulatory groups who impose similarly stringent audit requirements.

“The bar for compliance is raised every single day, it seems,” says Wolff-Long. “And of course you have to update all your filing processes too. Even when you want to make improvements, you have no idea about how quickly you can implement them. You can change but change is slow – there is no way to make fast changes in the approved product market.”

The reality of the situation, however, does not stop time being money nor speed everything for pharm companies who outsource processes to firms like CBL. It is most noticeable among smaller and or newer drug manufacturers who live closer to the edge of viability than much larger members of the industry.

Educating the client

“Everybody is outsourcing these days and this creates a thriving market for us,” says Wolff-Long. “But there is the question of how fast you can take on new projects. We get some of our clients because some competitors have not been able to meet the timelines they want because of compliance issues. Of course this also means that when they do finally come to us, the timelines are even shorter because of the problems elsewhere.”

She continues: “We do have to try and educate the clients and to help them through the pitfalls. The bigger the client the more they understand but of course we want to work with smaller and newer clients as well. That’s the flexibility we have and that we need in order to succeed. We like to get involved in the project management stage, even before they’ve necessarily signed up definitely to use us. They are using us because we have expertise that they don’t.”

Getting in at an early stage means that CBL can deal with the practical considerations as well as regulatory ones. For example the containers required for the drug, which have, in some cases, to be designed, approved and ordered. “If we need to order new vials there is sometimes a 12-week lead time,” says Wolff-Long. “For the stoppers that can rise to 20 weeks.

That means if a potential client has trials starting in just a week, we can’t help them. It would help, of course, if they could use ones that we already have but in the 14 lines we currently have, no two use the same vial/stopper combination.”

As an end point in the production process, CBL does not have any research and development requirements as such but its technology transfer team is constantly called on to design the way that new and existing products fit into the production line.

“We have learnt it is not always possible to meet the most aggressive timelines that some of our existing or potential clients would like. We need to set realistic expectations but also gear the business to be as efficient as possible.”

Parental comfort

That education has come through a bitter experience: in 2001 CBL’s at the time new parent company, Cangene, based in Winnipeg, invested in excess of $15 million in plant for CBL to manufacture vaccines. However the plant was shut down a few years ago having failed to make any significant contribution to the business.

“Moving towards vaccines affected our core business and to be honest we took a hit through not satisfying our existing customers’ expectations. We have made some tough decisions, however, and now I believe we have regained our reputation in the sector.”

As a parent and partner, Cangene provides CBL with stability and security, says Wolff-Long. “There is a physical distance between us but there is also a warm relationship that has allowed to grow and expand. We went from a very small facility to one that’s a decent size, about 50,000sq ft. And we have become a much more commercial organization.

CBL operates very much as a separate business but particularly in this time of change and development Cangene helps to smooth out the ups and downs in revenue and cashflow that are an inevitable consequence. It has provided us with structure and space and the improvements can be seen in the results. The numbers over the last five years speak for themselves. Besides the investment we need to make would be very difficult without Cangene.”

More investment is on the way, which will help CBL to improve its services still further and bring time to market down as far as regulations will allow. It will also help it mine that best opportunity for new business belonging to any company: a well satisfied existing customer base.