The latest from CDMOs, CMOs, and suppliers featuring Adare Pharma Solutions, Cytiva, PCI Pharma Services, and PharmaLogic.  

Chemicals/Chemical API Manufacturing 
* PharmaLogic Opens Radiopharmaceutical Mfg Facility   
Biologics Manufacturing 
* Cytiva Adds New Viral Vector Development Cell Lines 
Formulation Development/Drug Product Manufacturing 
* Adare To Expand High-Potency Handling & Packaging Capabilities
* PCI Pharma Services Expands Sterile Fill–Finish Facility 

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Chemicals/Chemical API Manufacturing 

PharmaLogic Opens Radiopharmaceutical Mfg Facility   
PharmaLogic, a Boca Raton, Florida-based CDMO of radiopharmaceuticals, has opened a new radiopharmaceutical production and research facility in Cincinnati, Ohio. The new production and laboratory space is equipped for PharmaLogic to expand current production and focus additional efforts on research and development of compounds. 

Source: PharmaLogic 

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Biologics Manufacturing 

Cytiva Adds New Viral Vector Development Cell Lines 
Cytiva has announced the creation of three new cell lines for adeno-associated virus (AAV) production. Together, the three lines meet the objectives of various therapeutic programs with the ability to transition between cell lines and can be paired with Cytiva’s cell-culture media capabilities. The three cell lines include: (1) a transient cell line for researchers that is paired with a new cell-culture medium, HyClone prime expression; both the cell line and corresponding media will be available soon; (2) a packaging cell line for screening of genes of interest for use in clinical development; this cell line is available now in selected formulations;  and (3) a producer cell line that integrates all four required genes for AAV production. The production starts by adding an induction agent; no transfection is needed. This cell line is available now to be customized to each individual therapy. 

Source: Cytiva 

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Formulation Development/Drug Product Manufacturing 

Adare To Expand High-Potency Handling & Packaging Capabilities 
Adare Pharma Solutions, a CDMO of drug products and drug-delivery services, has announced expansions of its high-potency handling capabilities in the US and Europe. 

In the US, the company is adding a second high-potency suite to its 128,000-square-foot facility in Philadelphia. The suite will provide encapsulation, high-shear granulation, blending, and other manufacturing processes. Construction of the new suite will be completed by the fourth quarter of 2024 and will complement the site’s existing potent suite, which provides roller compaction, milling, bin blending, and tablet compression. In addition, the company will add a bottle packaging line providing turnkey support for highly potent clinical supplies and commercial products. The high-potency bottle packaging line will be operational in the fourth quarter of 2024. 

The company will also upgrade its179,000-square-foot facility in Ohio with several R&D-to-clinical-stage production suites to provide high-potency handling. Capabilities will include dry roller compaction, microencapsulation, and fluid bed processing. Work is already underway at the site and is scheduled for completion by the fourth quarter of 2024. 

In Europe, Adare’s 220,000-square-foot facility in Milan, Italy, will add high-potency upgrades to its analytical and formulation laboratories, including fluid-bed processing, bin blending, compression, encapsulation, and pan-coating capabilities. 

The company also recently announced plans to add packaging capabilities and more warehousing capacity at its site in Italy, as well as high-shear granulation mixing that can utilize either aqueous or organic-based solutions. These expansions, as well as the high-potency upgrades, will be operational by the end of 2024. 

Source: Adare Pharma Solutions 

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PCI Pharma Services Expands Sterile Fill-Finish Facility 
PCI Pharma Services, a Philadelphia, Pennsylvania-based CDMO of drug products and contract packager, has begun installation of key equipment for its newest sterile fill-finish facility on the company’s Bedford, New Hampshire, campus.  

Twin lyophilizers and a large-scale isolator filling line are being installed at the forthcoming 50,000-square-foot plant, as foundational components of a previously announced and multi-year $100 million capital investment project.  

The facility will provide increased capacity using Annex 1-compliant technology, including an aseptic fill-finish line within a fully isolated containment system, complete with twin 430-square-foot lyophilizers featuring automatic loading and unloading systems. The integrated filler will be capable of manufacturing batch sizes of up to 300,000 vials at a rate of up to 400 vials per minute, providing large-scale capacity for the filling of late-phase clinical and commercial small molecules and biologics, including drug products with monoclonal antibodies, oligonucleotides, fusion proteins, and peptides. 

Engineering and validation runs at the new facility are scheduled to occur in late fall 2024, with the line ready for GMP production in the first quarter of 2025. 

Source: PCI Pharma Services