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Cool Runnings

Thu, 08/15/2013 - 10:36am
Mike Auerbach, Editor in Chief

In the well-known children’s story The Three Bears, Goldilocks moves from bed to bed and from one bowl of porridge to another until she finds one that is “just right”. Aptly named “The Goldilocks Principle” this quest for finding products, services or a business partner that hinges on the relationship being “just right” can certainly be applied when choosing a pharmaceutical contract manufacturer.
If you find a company that offers the experienced professionals, systems and capacities needed to effectively and efficiently handle your project – you know you’ve found the right partner.
Such is the case of LSNE; a contract manufacturer based in Bedford, NH that offers formulation and cycle development, GMP fill/finish and lyophilization services at a scale that has proven very successful for the company and its clients.

Background
LSNE started in 1997 as Lyophilization Services of New England. President Matthew Halvorsen was working for another company at the time and was outsourcing his company’s lyophilization projects and found that he was never satisfied with the results and the relationship and thought he could do better. Halvorsen left that company and started his own lyophilization services company with one unit. His first customer was his previous employer and they are still a client today. The company has also expanded from that one lyophilizer in 1997 to the 26 they use today, making them the CMO with the largest lyophilization capacity on the east coast.
LSNE has been slowly transitioning away from the Lyophilization Services of New England name. Christine Palus, the company’s Vice President of Sales and Marketing explains that the former name limited the company and didn’t fully represent the services it offered. “The name Lyophilization Services of New England does not reflect the wide range of offerings that we provide.  We also wanted to market our services to the global market and not just our regional clients.”
One of the first things the company did to begin its rebranding was to develop a new logo in November 2012. Reminiscent of a snowflake – the new logo hints at the complete range of services the company offers. “When we lost the ‘lyophilization’ out of our name we didn’t want our clients to forget that that’s our area of expertise,” says Palus. “We wanted to make sure our logo showed our lyo background. So it does look like a snowflake – which hints to the freeze drying – also where the sections of the arches come together – there are water droplets – which speaks to our fill/finish capabilities – it also looks like 6 people holding hands which is meant to represent us working together with our clients.”
A tidy logo for a tidy company.

New Hampshire Facilities
The company currently operates three facilities; two in Bedford and one in Manchester all within a 10-minute radius.
The company’s original facility on Sundial Avenue in Manchester was established in 1997 and is currently being used for medical device manufacturing and features 8 lyophilizers in sizes from 12 square feet to 179 square feet. According to Palus, the Sundial Ave. facility is strictly for medical devices as the facility does not have a drug registration.


The company’s Harvey Road facility, as it’s called, in Bedford was established in 2005 as a sterile multi-use facility for drug manufacturing. In 2011 it became a dedicated facility for a client’s commercial product and will remain so for the next several years. LSNE upgraded the facility for the new client by making the facility not only FDA compliant but also compliant with EU regulations.
LSNE’s third facility is located on Commerce Drive in Bedford and is also the company’s newest. Established in 2009, the Commerce Drive facility manufactures drugs and medical devices. The building was completely gutted and renovated in 2010 and all validation work was completed in 2011. The first sterile GMP lot at the facility was produced in June 2011. The facility boasts 10 lyophilizers ranging in capacities from 4 sq. ft. all the way up to 270 sq. ft.
Based on the capabilities of the company’s three facilities the company is well-positioned to deal with any market fluctuations, as Palus explains. “There are two sides to the company - the medical device side and the sterile manufacturing side. From what we’ve seen, the drug manufacturing business goes up and down based on economic conditions. The medical device business is steadier and it’s a nice way to ensure revenue for the company and is a steady reliable business. This makes LSNE a stable company.”

A Closer Look at the Commerce Drive Facility
To date, the facility on Commerce Drive in Bedford has primarily been used to produce material for development and clinical trials. According to Palus, many of LSNE’s clients come to them for Phase 1 trial materials for which LSNE can do the fill/finish, and then clients will come back for Phase 2 lots and eventually the Phase 3 and process validation lots. The company's focus moving forward is shifting towards more small scale commercial lots so that they can meet the needs of their current clients as well as opportunities with new clients.


As CMO’s work with different products from numerous clients, a hot-button issue in the industry is the subject of cross-contamination. At LSNE they are taking every precaution to avoid this problem as Palus explains. “This is an interesting situation. Since we are being diligent and asking potential clients for toxicology information and validated cleaning methods for their compound – they sometimes say to us that they can just go to another CMO who doesn’t ask us for so much documentation and get the job done. What they don't always understand is that we are trying to minimize the risk of contamination and do what is best for their product from a regulatory standpoint."
One way that LSNE minimizes contamination issues is to have all incoming compounds reviewed by a toxicologist to determine what level of containment is required for each specific project. Since lyophilizers are too big and expensive to be considered disposable, they are thoroughly cleaned after each run using a validation cleaning method. Most vessels too are disposable, but if they are too expensive to be disposable, for example, if they are customized in any way for a client, the then vessel becomes 100% dedicated to that product.
FDA and Client Audits
As the industry continues to work towards producing the highest quality products, CMOs like LSNE have seen a change in the tone of both FDA and client audits.
“Clients are a lot more conservative than they used to be,” says Palus, “and we see this during our client audits. A lot of our clients have worked with a CMO that had regulatory problems and they have been burned by that experience. We’ve noticed these clients are naturally more cautious when they come to us."
LSNE is confident with their quality systems. "We average about 40 client audits per year," says Palus. "That is a lot of eyes looking at our SOPs.”
"We have also seen a more conservative attitude coming from regulators and we strive to keep up with the changing regulatory requirements," says Palus. "Practices that were acceptable in the past are no longer considered acceptable and as a company we are continuously updating our quality systems to maintain compliance and to produce the highest quality products for our clients."
To further add to their regulatory accomplishments, the company's 25 Commerce Drive facility in Bedford has received a Certificate of GMP Compliance from the UK Medicines and Healthcare products Regulatory Agency (MHRA) to manufacture aseptic lyophilized drug products for use in the European Union. This certificate is a significant accomplishment for LSNE, and now allows the Bedford manufacturing facility to manufacture sterile lyophilized drug products for marketing in the European Union. 

The Right Fit
LSNE’s fill/finish and lyophilization manufacturing services are right-sized for the types of clients they are hoping to reach. “LSNE is not going to compete with the big CMOs – we are not going to be a CMO that does 250,000 vials per batch,” says Palus. “We are a good fit for orphan indication drugs and low volume commercial products. Our clients call us and tell us that the large CMOs aren’t interested in their product because they only need one batch per year. That’s where we fill the gap in the industry. We noticed there was not a lot of capacity out there for small-scale commercial products.”
One of LSNE’s main selling points and what they think sets them apart from other CMOs performing the same services is that they work with their clients from development all the way through commercialization. “By working with the same CMO all the way through,” says Palus, “you are going to minimize risk and also reduce time to market. By avoiding multiple tech transfers we get to know the process, the compound and all of the little intricacies. We are not surprised by anything.”

Future plans
LSNE has created a very stable foundation for its business to grow and is already making plans for expansion. The company is planning a new central warehouse near its Commerce Drive facility and there are plans to add another manufacturing site.
"We have succeeded based on our client demands,” says Palus. “We are very in touch with our clients and add capacity as needed rather than add facilities and let them sit unused. We are not going to stray from our core competencies.”

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