Tim Wright, Editor05.08.18
Lyophilization Services of New England (LSNE), a contract development and manufacturing organization (CDMO), recently unveiled a strategic plan to expand its quality control (QC) laboratory in Bedford, NH. The build-out calls for 37,000 square feet of new QC laboratory space and a centralized warehouse. Additionally, in conjunction with this expansion, LSNE will add approximately 45 new full-time positions.
The new, state-of-the-art laboratory will allow LSNE to increase its analytical and microbiology capabilities, to continue to support clients with their clinical and commercial products.
The laboratory building, located on LSNE’s campus, will also house LSNE’S newly renovated centralized warehouse to support the company’s continued growth, including the offering of longer-term product storage for clients. The laboratory and warehouse are scheduled to be validated and operational during the second quarter of 2018. Recently, Contract Pharma had a chance to sit down with Jeff Clement, Director of Sales at LSNE and talk about the new lab.
Contract Pharma: Why was the decision made to expand LSNE’s lab space?
Jeff Clement: We listened to our clients. It’s been our company philosophy since the beginning. LSNE started out as a development and manufacturing company for lyophilized products. Then, as we grew, we got more and more into manufacturing, starting off with building our medical devices and diagnostics client base. Then we made the natural progression into sterile drug product manufacturing.
Recently we’ve heard from a lot of our clients that have long lead times with some of their 3rd party quality control (QC) testing labs. We’ve always had a QC lab, but we thought it would be an opportune time to further support our clients and increase our analytical capabilities. Our laboratory is expanding in both personnel and equipment, while the actual size of it will grow about four-fold.
The whole build out is comprised of QC lab space and a consolidated warehouse with large capacity for controlled storage requirements. We currently have four manufacturing sites.
Each one of them has their own warehouse space. Part of the plan with this new 38,000 sq. ft. of space is to have that as a consolidated warehouse. Now each of the individual manufacturing sites have more of a ‘just-in-time’ warehouse. This allows us to be more nimble and responsive to the client’s schedules. Additionally, we now have more manufacturing supplies available to support our clients.
CP: How does the new space help address customer needs?
JC: All of our clients will have either testing to get their Active Pharmaceutical Ingredient (API) or the Bulk Drug Substance (BDS) released, as well as any in-process control testing, release testing and/or stability testing. Some of the bottlenecks we’ve seen occur is when our clients do not have a method assay established yet. That will slow down the process if they’re outsourcing that method to a third party laboratory and we’ve heard from our clients that the lead times on testing are getting longer and longer. Our QC team will be available for clients to develop assays or take an existing assay from the upstream manufacturer and further develop that or optimize it depending on the stage of the product.
CP: How does the expansion complement other business capabilities and fold into other areas of expertise?
JC: It’s really two-fold. The first part revolves around working with our existing client base. We’ve upgraded the instrumentation we have for high performance liquid chromatography (HPLC) and ultra-performance liquid chromatography (UPLC) testing and have increased personnel for a lot of standard physical chemistries like osmolality and pH testing. In fact, we recently have moved our QC function to a 7 Day, two shift operation. I also mentioned the scientists we’ve brought onboard to perform method development and we’re also getting into more complex process formulation and filling. A lot of these capabilities require specialized equipment. Recently we’ve added on gas chromatography (GC) equipment. We’re also in the process of getting GC upgraded so we can test the head space analysis on residual solvents. Recently we even added a headspace analyzer to determine oxygen content in the vials.
In addition, we’ve had a number of clients developing nanoparticles or micro-sphere products. In response to this trend we offer a dedicated ISO-5 formulation suite. We also added a particle sizer and zeta potential testing to our capabilities in supporting this emerging area.
So these are some of the things we’ve added on to further support our traditional existing clients. The additional equipment will help to support our newer types of complex processes.
The second part of LSNE’s recent growth has to do with expanding into the existing analytical market. Traditionally, we’ve only supported the projects that we’re manufacturing. But right now we’re expanding our testing services for different dosage forms. Historically, LSNE has only worked with injectable drug products, but now we’re actually getting into stand-alone testing where we can test for not only APIs or intermediates, but we can also test for oral products, topicals, and other various routes of administration.
Overall, LSNE is going through a broad expansion much beyond our traditional niche.
CP: What have been some of the challenges encountered during this expansion process?
JC: I think with the QC space the biggest challenge that we’ll have, especially where we’re outside of the parenteral marketplace, is dealing with the fact that we may not be well known in the oral dosage form and topicals market. We can perform that testing but I don’t think anybody would really be looking for us to do it. We’re going to have to get out into the market and let people know that we’re now offering these standalone testing capabilities. Especially where some companies might have a pain point of long lead times, now we’re willing to take on new business, where traditionally it’s only been a supporting arm of our business.
We’ll be undergoing branding and marketing initiatives while training sales staff to sell the analytical services we now offer. Ultimately, it’s about letting our existing customers, as well as potential new customers, know that we can provide more now than just a manufacturing supporting role in the analytical services area.
CP: What are some of trends in general driving the analytical and microbiological testing market?
JC: I think a lot of the drive right now has to do with the through-put of business in general. A lot of the well-known analytical testing labs are overbooked so it presents an opportunity for a company like ours that does have excess QC capacity to expand our horizons a little bit and move further into the analytical testing space.
CP: In addition to the new lab space and warehouse, are there any other expansion plans?
JC: We are now working with our existing commercial clients to perform the labelling and meet all the new serialization requirements for them. In addition, we’ll also offer these capabilities as a stand-alone service. I think we’re a little bit ahead of the curve, by getting our commercial clients all set with the outside vendor, which has in-turn provided us with a lot of experience in this area. Now we’re taking that experience and working with a vendor to perform those services at LSNE. There’s potential for us to be doing labelling for a lot of our competitors which will be a great opportunity for us.
Additionally, LSNE recently acquired PSC Biotech’s cGMP aseptic fill finish manufacturing facility located in Madison, WI. This acquisition allows LSNE to expand its manufacturing capabilities, add new service offerings and accommodate its customers’ project timing requirements. The new facility will be called LSNE-Madison.
CP: What are some other areas LSNE will look to grow its business moving forward?
JC: While we will always maintain our core manufacturing in supporting our clients, we’ll also continue to expand our horizons such as with the expanded QC capabilities and the serialization initiative. A couple other markets that we’re looking at now for potential growth is in the area of gene therapy and microbiome products. There is a lot of recent interest in these areas.
Our company philosophy is we look to buy our own buildings so we can react quickly and respond to market demands. Right now we have a couple buildings we’re planning further expansion into on our Bedford, NH campus. One of these areas will focus on gene therapy and microbiome products. For now we’re calling it “flex-space” where we will start with some development of these microbiome live cell products that is completely outside our standard GMP manufacturing process in completely separate facilities. Our first projects will be non-GMP R&D work. But what we have going for us is 21 years of lyophilization experience that will help us develop lyophilization cycles for the client. One of our sites has a lot of bulk lyophilization capabilities, and while this work would not be performed at that site, the experience we have in bulk lyophilization is readily transferable with the microbiome products.
This is one other way we’re getting our name out there to see how the market is looking at us. We’ll see how it goes and ultimately decide if we want to make that leap in investment into getting some GMP manufacturing for microbiome and gene therapy products, in the near future.
The new, state-of-the-art laboratory will allow LSNE to increase its analytical and microbiology capabilities, to continue to support clients with their clinical and commercial products.
The laboratory building, located on LSNE’s campus, will also house LSNE’S newly renovated centralized warehouse to support the company’s continued growth, including the offering of longer-term product storage for clients. The laboratory and warehouse are scheduled to be validated and operational during the second quarter of 2018. Recently, Contract Pharma had a chance to sit down with Jeff Clement, Director of Sales at LSNE and talk about the new lab.
Contract Pharma: Why was the decision made to expand LSNE’s lab space?
Jeff Clement: We listened to our clients. It’s been our company philosophy since the beginning. LSNE started out as a development and manufacturing company for lyophilized products. Then, as we grew, we got more and more into manufacturing, starting off with building our medical devices and diagnostics client base. Then we made the natural progression into sterile drug product manufacturing.
Recently we’ve heard from a lot of our clients that have long lead times with some of their 3rd party quality control (QC) testing labs. We’ve always had a QC lab, but we thought it would be an opportune time to further support our clients and increase our analytical capabilities. Our laboratory is expanding in both personnel and equipment, while the actual size of it will grow about four-fold.
The whole build out is comprised of QC lab space and a consolidated warehouse with large capacity for controlled storage requirements. We currently have four manufacturing sites.
Each one of them has their own warehouse space. Part of the plan with this new 38,000 sq. ft. of space is to have that as a consolidated warehouse. Now each of the individual manufacturing sites have more of a ‘just-in-time’ warehouse. This allows us to be more nimble and responsive to the client’s schedules. Additionally, we now have more manufacturing supplies available to support our clients.
CP: How does the new space help address customer needs?
JC: All of our clients will have either testing to get their Active Pharmaceutical Ingredient (API) or the Bulk Drug Substance (BDS) released, as well as any in-process control testing, release testing and/or stability testing. Some of the bottlenecks we’ve seen occur is when our clients do not have a method assay established yet. That will slow down the process if they’re outsourcing that method to a third party laboratory and we’ve heard from our clients that the lead times on testing are getting longer and longer. Our QC team will be available for clients to develop assays or take an existing assay from the upstream manufacturer and further develop that or optimize it depending on the stage of the product.
CP: How does the expansion complement other business capabilities and fold into other areas of expertise?
JC: It’s really two-fold. The first part revolves around working with our existing client base. We’ve upgraded the instrumentation we have for high performance liquid chromatography (HPLC) and ultra-performance liquid chromatography (UPLC) testing and have increased personnel for a lot of standard physical chemistries like osmolality and pH testing. In fact, we recently have moved our QC function to a 7 Day, two shift operation. I also mentioned the scientists we’ve brought onboard to perform method development and we’re also getting into more complex process formulation and filling. A lot of these capabilities require specialized equipment. Recently we’ve added on gas chromatography (GC) equipment. We’re also in the process of getting GC upgraded so we can test the head space analysis on residual solvents. Recently we even added a headspace analyzer to determine oxygen content in the vials.
In addition, we’ve had a number of clients developing nanoparticles or micro-sphere products. In response to this trend we offer a dedicated ISO-5 formulation suite. We also added a particle sizer and zeta potential testing to our capabilities in supporting this emerging area.
So these are some of the things we’ve added on to further support our traditional existing clients. The additional equipment will help to support our newer types of complex processes.
The second part of LSNE’s recent growth has to do with expanding into the existing analytical market. Traditionally, we’ve only supported the projects that we’re manufacturing. But right now we’re expanding our testing services for different dosage forms. Historically, LSNE has only worked with injectable drug products, but now we’re actually getting into stand-alone testing where we can test for not only APIs or intermediates, but we can also test for oral products, topicals, and other various routes of administration.
Overall, LSNE is going through a broad expansion much beyond our traditional niche.
CP: What have been some of the challenges encountered during this expansion process?
JC: I think with the QC space the biggest challenge that we’ll have, especially where we’re outside of the parenteral marketplace, is dealing with the fact that we may not be well known in the oral dosage form and topicals market. We can perform that testing but I don’t think anybody would really be looking for us to do it. We’re going to have to get out into the market and let people know that we’re now offering these standalone testing capabilities. Especially where some companies might have a pain point of long lead times, now we’re willing to take on new business, where traditionally it’s only been a supporting arm of our business.
We’ll be undergoing branding and marketing initiatives while training sales staff to sell the analytical services we now offer. Ultimately, it’s about letting our existing customers, as well as potential new customers, know that we can provide more now than just a manufacturing supporting role in the analytical services area.
CP: What are some of trends in general driving the analytical and microbiological testing market?
JC: I think a lot of the drive right now has to do with the through-put of business in general. A lot of the well-known analytical testing labs are overbooked so it presents an opportunity for a company like ours that does have excess QC capacity to expand our horizons a little bit and move further into the analytical testing space.
CP: In addition to the new lab space and warehouse, are there any other expansion plans?
JC: We are now working with our existing commercial clients to perform the labelling and meet all the new serialization requirements for them. In addition, we’ll also offer these capabilities as a stand-alone service. I think we’re a little bit ahead of the curve, by getting our commercial clients all set with the outside vendor, which has in-turn provided us with a lot of experience in this area. Now we’re taking that experience and working with a vendor to perform those services at LSNE. There’s potential for us to be doing labelling for a lot of our competitors which will be a great opportunity for us.
Additionally, LSNE recently acquired PSC Biotech’s cGMP aseptic fill finish manufacturing facility located in Madison, WI. This acquisition allows LSNE to expand its manufacturing capabilities, add new service offerings and accommodate its customers’ project timing requirements. The new facility will be called LSNE-Madison.
CP: What are some other areas LSNE will look to grow its business moving forward?
JC: While we will always maintain our core manufacturing in supporting our clients, we’ll also continue to expand our horizons such as with the expanded QC capabilities and the serialization initiative. A couple other markets that we’re looking at now for potential growth is in the area of gene therapy and microbiome products. There is a lot of recent interest in these areas.
Our company philosophy is we look to buy our own buildings so we can react quickly and respond to market demands. Right now we have a couple buildings we’re planning further expansion into on our Bedford, NH campus. One of these areas will focus on gene therapy and microbiome products. For now we’re calling it “flex-space” where we will start with some development of these microbiome live cell products that is completely outside our standard GMP manufacturing process in completely separate facilities. Our first projects will be non-GMP R&D work. But what we have going for us is 21 years of lyophilization experience that will help us develop lyophilization cycles for the client. One of our sites has a lot of bulk lyophilization capabilities, and while this work would not be performed at that site, the experience we have in bulk lyophilization is readily transferable with the microbiome products.
This is one other way we’re getting our name out there to see how the market is looking at us. We’ll see how it goes and ultimately decide if we want to make that leap in investment into getting some GMP manufacturing for microbiome and gene therapy products, in the near future.
