Upon launching a lyophilization development program, LSNE will review the current formulation of the product to evaluate whether it is amenable to lyophilization. LSNE can develop a formulation de novo or optimize the current formulation and evaluate different buffering systems, bulking agents and/or cryoprotectants. By using multiple lyophilizers, we can perform the lyophilization development runs in parallel, which not only provide our clients with a cutting edge development process to rapidly identify a suitable process, but a cost saving is realized as well.
LSNE works with our clients to improve lyophilization processes at all stages, from developing a formulation and lyophilization cycle in-house, to optimizing a commercial stage lyophilization cycle to reduce its length and again reduce cost. Recently, LSNE was transferring a manufacturing process to our cGMP aseptic drug product facility for a late stage product that had obtained commercial approval. The lyophilization cycle for the product, which was a monoclonal antibody, was reviewed and the lyophilization time seemed lengthy. We coordinated a meeting with the client and LSNE’s Formulation and Lyophilization Development team and, thereafter, performed a lyophilization optimization program to reduce the lyophilization cycle time. The lyophilization development program was a success and the lyophilization cycle was reduced by 18% which realized an immediate impact on the client’s cost of cGMP manufacture of the product. The client achieved an immediate ROI and paid for the cost of development after just a few cGMP manufacturing runs. This is an example of our success with a mature commercial product. Our optimization programs for earlier stage products typically yield dramatic decreases in [OL J`JSL [PTL HUK PTWYV]LTLU[Z PU [OL V]LYHSS WYVK\J[ WYVÄSL
To support our client’s lyophilization development programs, we evaluate the shelf-life of the product under various accelerated storage conditions with a short-term stability program. Once the product has demonstrated Z\MÄJPLU[ Z[HIPSP[` HUK TV]LZ [V J.47 THU\MHJ[\YPUN 3:5, JHU WLYMVYT a long-term ICH stability study on the Drug Product.
LSNE’s R&D team works closely with the manufacturing team to ensure a process developed by LSNE is transferrable to LSNE’s GMP Operations Group and cGMP equipment.
Can you elaborate on LSNE’s facilities and capabilities? What sets you apart from other companies that operate in the same market segment?
LSNE has been developing lyophilization cycles and providing manufacturing for the last 20 years. We have three commercially approved cGMP compliant manufacturing sites with different areas of expertise. I think what really sets us apart is that if a product can be lyophilized, we’ve probably handled it. I’d be hard pressed to name another CDMO with our breath and depth of experience. Our experience ranges from diagnostics, medical devices, bulks, intermediates, APIs, as well as drug product. Additionally, we’ve worked with some very complex lyophilized dosage forms that were suspensions/emulsions or liposomal formulations. In addition to our standard ISO 7 formulation room where ^L MVYT\SH[L WYVK\J[Z [V IL Z[LYPSL ÄS[LYLK PU[V V\Y 0:6 ÄSS Z\P[L 3:5, has a dedicated ISO 5 formulation suite that we can use to aseptically WYVJLZZ WYVK\J[Z [OH[ JHUUV[ IL Z[LYPSL ÄS[LYLK VY [LYTPUHSS` Z[LYPSPaLK ;OPZ OHZ ILLU ILULÄJPHS [V H SHYNL U\TILY VM V\Y JSPLU[Z KL]LSVWPUN TPJYVWHY[PJSL HUK UHUVWHY[PJSL WYVK\J[Z [OH[ JHUUV[ IL Z[LYPSL ÄS[LYLK
LSNE is a worldwide supplier that has been inspected by the MHRA. As a result of the inspection, we received a letter of GMP compliance to aseptically manufacture both liquid and lyophilized drug product. Additionally, we host multiple QP audits per year. We also support our clients’ programs globally, including Asia and Israel.
To protect our clients’ valuable drug product, all of LSNE’s manufacturing equipment are on redundant systems and linked to our backup generator.
LSNE’s facilities team offers fast and reliable maintenance which allows us to be self-reliant and not dependent on outside technical service organization to support our equipment. This in-house expertise gives us the ability to work with formulations containing organic solvents, which is a capability that very few of our competitors can accommodate.
Looking ahead, can you describe some of the
technologies and capabilities that will be needed for scaling-up and processing future pharmaceuticals that might fall into categories such as potent/ toxic compounds, or products that have very high dollar values, and products that might be stored in containers other than glass? Is LSNE actively looking at these issues and ready to offer solutions to the industry and their clients?
As the biologics market continues to mature and new products enter the clinic, LSNE’s techniques for minimizing line-loss continue to gain LMÄJPLUJ` >L OH]L H SHYNL WLYJLU[HNL VM JSPLU[Z KL]LSVWPUN TVUVJSVUHS antibodies and with each new client we have discussions about the high expense of the product and how we will work to maximize the \ZL VM L]LY` KYVW 3:5, OHZ ZLLU H ZPNUPÄJHU[ PUJYLHZL PU [OL U\TILY of companies developing RNAi or siRNA products and the cost of the oligonucleotide drug substance is very high as well. With our years of working with monoclonal antibodies we are extremely well positioned [V ^VYR ^P[O VSPNVU\JSLV[PKLZ PU HU LMÄJPLU[ HUK JVZ[ LMMLJ[P]L THUULY
LSNE systematically reviews business metrics to consider and then decide what areas to add to our capabilities or target drug types for our existing capabilities. We evaluate new therapeutic advancements that currently Ä[ PU[V V\Y L_PZ[PUN JHWHIPSP[PLZ VY ^OH[ Z`Z[LTZ VY JHWHIPSP[PLZ ^L TH` need to enhance or add-on for new novel technologies being developed. LSNE also has the ability to expand our current manufacturing facilities to Z\WWVY[ [OL ZWLJPÄJ ULLKZ VM UL^ SHYNLY ZJHSL WYVQLJ[Z
As more companies are developing therapeutics with Orphan Drug Designation, LSNE is working with our clients and potential clients to expeditiously move their product into and through clinical development. LSNE batch sizes are perfect for drugs that will be receiving or have received Orphan Drug Designation. Our Quality Team stays abreast of the latest regulatory changes to stay compliant and streamline support HJ[P]P[PLZ :\JO LMÄJPLUJPLZ PUJS\KL PU OV\ZL YLN\SH[VY` ^YP[PUN Z\WWVY[ HUK OH]PUN H ;`WL = +4- VU ÄSL ^P[O [OL -+(
To support the growth in the outsourcing industry, LSNE is continuing to expand our facilities as well as our employees. LSNE’s staff has grown ZPNUPÄJHU[S` V]LY [OL SHZ[ JV\WSL VM `LHYZ HUK ^L HYL JVU[PU\PUN [V HKK RL` LTWSV`LLZ Z\JO HZ PUK\Z[Y` :\IQLJ[ 4H[[LY ,_WLY[Z PU THU` ÄLSKZ We are continually adding staff with industry experience to increase competitive advantage over other CMOs.
pharmoutsourcing.com | 27 | November/December 2016
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