NDLI: Development of Biotechnology Products in Pre-filled Syringes: Technical Considerations and Approaches

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AAPS PharmSciTech : Volume 12, Issue 1, March 2011

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Development of Biotechnology Products in Pre-filled Syringes: Technical Considerations and Approaches

Content Provider	Springer Nature Link
Author	Badkar, Advait Wolf, Amanda Bohack, Leigh Kolhe, Parag
Copyright Year	2011
Abstract	A monoclonal antibody (mAb) product development case study is presented to address some of the issues faced during developing a pre-filled syringe (PFS) product for a biotherapeutic. In particular, issues involving incompatibility with silicone oil and a stability-based approach for selection of PFS barrel and tip cap components have been discussed. Silicone spiking studies followed by exposure to agitation stress or accelerated temperature conditions were used to check for incompatibilities of the mAb with silicone oil, a necessary product contact material in PFS. In addition, screening studies to compare various closure materials as well as syringe barrel processing methods were used to select the optimum closure materials as well as the correct syringe processing method. Results indicate that the model mAb formulation used was sensitive to high levels of silicone oil especially under accelerated temperature conditions resulting in formation of protein–silicone particles in the solution for samples that were spiked with the silicone oil. Agitation stress did not have any significant impact on the quality attributes tested. Samples stored in syringe barrels that were processed with sprayed-on silicone had higher levels of subvisible particles as compared to those that were processed with the baked-on process. The tip cap comparability study resulted in one tip cap material having superior compatibility among the three that were tested. The quality attribute that was most impacted by the tip cap materials was mAb oxidation. An approach for evaluation of primary packaging components during the development of pre-filled syringe presentations for biotechnology-based compounds has been highlighted.
Starting Page	564
Ending Page	572
Page Count	9
File Format	PDF
Journal	AAPS PharmSciTech
Volume Number	12
Issue Number	2
e-ISSN	15309932
Language	English
Publisher	Springer US
Publisher Date	2011-05-04
Publisher Institution	American Association of Pharmaceutical Scientists
Publisher Place	Boston
Access Restriction	One Nation One Subscription (ONOS)
Subject Keyword	formulation development PFS pre-filled syringes container closure system protein development silicone oil compatibility syringe processing tip cap selection Pharmacy Biochemistry Biotechnology Pharmacology/Toxicology
Content Type	Text
Resource Type	Article

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