The Contract Development and Manufacturing Organizations (CDMOs) sector is flourishing in today’s pharma/biopharmaceutical landscape, bolstered by growing pipelines, increasingly complex therapies, greater costs associated with drug development and manufacturing, and demand driven by the pandemic. Biopharma companies increasingly rely on outsourcing to support the development and manufacture their pipelines.  
  
CDMOs provide access to highly specific and niche expertise along with the latest technologies in the growing field of injectable and biologic therapies. Complex manufacturing capabilities are needed for injectables including vaccines, monoclonal antibodies (MABs), proteins, oligonucleotides, among others, across various formats.

PCI Pharma Services (PCI), a pharma and biopharmaceutical services provider, recently entered an agreement to acquire Lyophilization Services of New England, Inc. (LSNE), a CDMO headquartered in Bedford, NH, from global private equity firm Permira. Founded in 1997, LSNE provides high-quality cGMP aseptic fill-finish services and expertise to scale lyophilization, an important manufacturing process commonly used with injectable and biologic therapies.

LSNE will expand PCI’s services as a global CDMO, building its expertise in biologics packaging and specialty manufacturing. The acquisition adds five FDA-approved facilities in the U.S. to PCI’s global 30-site network. LSNE is PCI’s fourth acquisition in three years, furthering its strategic focus on global specialty manufacturing capabilities and expertise.

Salim Haffar, Chief Executive Officer of PCI, discusses the motivating factors behind the LSNE acquisition and expanded capabilities and scale. –KB
 
Contract Pharma: What were the motivating factors behind the acquisition?

Salim Haffar: PCI was motivated by the ability to expand into the constantly growing pharmaceutical manufacturing market. Already a leader in biologics packaging, the acquisition of LSNE will allow us to implement their fill-finish capabilities and expertise in lyophilization. Since these are commonly used manufacturing processes in injectable and biologic therapies, we hope this will further cement PCI’s reputation as a prominent global CDMO.

CP: Can you talk me through the innovations that have made at-home administration & storage of biologics possible?

SH: The development of pre-filled syringes has simplified the process, as the risk of dosing inaccuracy is reduced. This way, there’s no need to re-measure and pharmaceutical companies can benefit from less overfill.

CP: In what areas does the combined company gain capabilities and/or scale?

SH: PCI gained capabilities in biologics manufacturing, specifically with cFMP aseptic fill-finish and the ability to scale lyophilization. PCI will be able to offer integrated large and small molecule solutions, including manufacturing capabilities in complex formulations. This also includes lyophilization for a wide array of injectables including nanoparticles, mRNA, mABs, proteins, oligonucleotides, and other biologics across formats from vials and bottles to pre-filled syringes and autoinjectors.

CP: What are some of the highly specific capabilities needed for today’s complex therapies?

SH: Lyophilization, or the freeze-drying process of removing water from the biologic, is a growing requirement for today’s complex therapies. This process, which involves placing the product under a vacuum and allowing the ice to change directly from solid to vapor without passing through a liquid phase, helps extend the shelf life of a biologic product. The acquisition of LSNE will allow PCI to manufacture biologics that last longer and serve more patients.

CP: Are there any other areas or opportunities PCI is looking to expand or add capabilities?

SH: PCI is constantly monitoring trends in the biologics packaging and manufacturing space to stay abreast of any changes. As the industry continues to evolve, PCI is committed to adjusting and re-focusing to any shifts. Otherwise, we’re at risk of falling behind.
 

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Salim has more than 23 years of experience in the pharmaceutical industry. Prior to his appointment as CEO at PCI Pharma Services, he served as President of Aptar Pharma, a leading global provider of drug delivery systems. Earlier in his career, Salim held a leadership role at Capsugel, as Senior VP, EMEA. Salim holds a Bachelor degree in Chemical Engineering from McGill University.