Speciality Chemicals Magazine MAR / APR 2022 - Page 68


Formulated fill-finish :

From curiosity to cure

The drug development team at Curia ( formerly AMRI ) demonstrates how manufacturers new to the large molecule space can benefit from endto-end services . Pharmaceutical companies that have exclusively specialised in small molecule APIs are now exploring other modalities , including biologics . Large molecules are proving their worth , both in the clinic and in a dramatic surge in sales . By 2026 , the global market for biologics is estimated to rise to $ 537 billion . 1 However , taking a drug substance through formulation to aseptic fill-finish is challenging and requires the services of a partner with a depth of experience , especially for early phase products with limited data where the path forward is undefined .

Range of modalities has expanded
Curia is no longer only a small molecule CDMO . With significant acquisitions and expansion of capacity , the company is now capable of handling an increased breadth of molecules and provides end-to-end services to modality-independent research organisations wanting to bring any drug from conception to market .
Doubling of clinical capacity allows scale up to GMP manufacturing
Finding production capacity has become a serious issue for manufacturers . Curia has immediate capacity , with validated fill-finish facilities in Camarillo , California and Glasgow , Scotland — each with , formulation and fill-finish suites . Both facilities have automated vial filling lines within restricted access barriers and have lines that can accommodate

End-to-end services

• Viral vectors
• mAbs
• Proteins
• Peptides
• Oligonucleotides
• Small molecules
• Cytotoxic
• Controlled substances
liquid and lyophilised presentations . Additionally , the Camarillo site provides automated syringe and cartridge filling capabilities . Best of all , the adjacent proximity of formulation development laboratories and scientists with the manufacturing suites and team facilitates collaboration and ensures process knowledge retention during tech transfer . Curia can handle cytotoxics and HPAPIs , with containment to an OEL of < 0.1 µ g / m 3 ( OEB Band 5 ), and is licensed to work with controlled substances .
Internal tech transfers reduce risk , time to market & cost
Robust formulation development is key to the successful transfer to aseptic fill-finish , especially for biologics . Drug developers who rely on separate CMOs for formulation development and aseptic fill-finish run the risk of an unsuccessful scale-up to GMP production . Our teams have seen numerous cases where small-scale development processes were improperly scaled up , resulting
• Liposomes & lipid nanoparticles
• Viscous biopolymers
• Suspensions
• Emulsions
• Formulation development
• Microfluidisation & high-shear homogenisation
• Extrusion
• Ultrafiltration / diafiltration
• Lyophilisation
• Broad supportive analytics
• Sterile / aseptic filling
in failed GMP runs . For example , development of lyophilisation processes must be done with direct knowledge of manufacturing-scale lyo capabilities . Ideally , formulation scientists collaborate directly with the team that completes aseptic fill-finish . Together , they combine their expertise in solubilization , particle sizing , product concentration , lyophilisation and process engineering . In this way they are able to anticipate manufacturing issues during formulation development , and the process is streamlined to maintain quality and reduce risk , time to market and cost . The fill-finish team receives a fully characterised drug product formulation , including assessment of its critical quality attributes ( CQAs ). Process-related stresses have been assessed , including those that impact the more-fragile large molecules , such as the effects of storage temperature , shear stress , freeze / thaw cycles , sensitivity to UV and visible light and stability of lyophilised formulations . •
Curia , formerly AMRI , is a leading contract research , development and manufacturing organisation providing products and services from R & D through commercial manufacturing of large and small molecules to pharmaceutical and biopharmaceutical customers . Curia ’ s 3,700 employees at 30 locations across the US , Europe and Asia help its customers advance from curiosity to cure .
Learn more at curiaglobal . com
1 : EvaluatePharma . World Preview 2020 , Outlook to 2026 . Accessed 4 Jan 22 at https :// www . evaluate . com / thought-leadership / pharma / evaluatepharma-world-preview-2020-outlook-2026