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Particle Characterization for a Protein Drug Product Stored in Pre-Filled Syringes Using Micro-Flow Imaging, Archimedes, and Quartz Crystal Microbalance with Dissipation.

Abstract Micro-flow imaging (MFI) has been used for formulation development for analyzing sub-visible particles. Archimedes, a novel technique for analyzing sub-micron particles, has been considered as an orthogonal method to currently existing techniques. This study utilized these two techniques to investigate the effectiveness of polysorbate (PS-80) in mitigating the particle formation of a therapeutic protein formulation stored in silicone oil-coated pre-filled syringes. The results indicated that PS-80 prevented the formation of both protein and silicone oil particles. In the case of protein particles, PS-80 might involve in the interactions with the hydrophobic patches of protein, air bubbles, and the stressed surfaces of silicone oil-coated pre-filled syringes. Such interactions played a role in mitigating the formation of protein particles. Subsequently, quartz crystal microbalance with dissipation (QCM-D) was utilized to characterize the interactions associated with silicone oil, protein, and PS-80 in the solutions. Based on QCM-D results, we proposed that PS-80 likely formed a layer on the interior surfaces of syringes. As a result, the adsorbed PS-80 might block the leakage of silicone oil from the surfaces to solution so that the silicone oil particles were mitigated at the presence of PS-80. Overall, this study demonstrated the necessary of utilizing these three techniques cooperatively in order to better understand the interfacial role of PS-80 in mitigating the formation of protein and silicone oil particles.
PMID
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Authors

Mayor MeshTerms
Keywords

Archimedes

micro-flow imaging (MFI)

pre-filled syringe

protein particles

quartz crystal microbalance with dissipation (QCM-D)

silicone oil particles

Journal Title the aaps journal
Publication Year Start




PMID- 27620008
OWN - NLM
STAT- Publisher
DA  - 20160917
LR  - 20160917
IS  - 1550-7416 (Electronic)
IS  - 1550-7416 (Linking)
DP  - 2016 Sep 12
TI  - Particle Characterization for a Protein Drug Product Stored in Pre-Filled
      Syringes Using Micro-Flow Imaging, Archimedes, and Quartz Crystal Microbalance
      with Dissipation.
AB  - Micro-flow imaging (MFI) has been used for formulation development for analyzing 
      sub-visible particles. Archimedes, a novel technique for analyzing sub-micron
      particles, has been considered as an orthogonal method to currently existing
      techniques. This study utilized these two techniques to investigate the
      effectiveness of polysorbate (PS-80) in mitigating the particle formation of a
      therapeutic protein formulation stored in silicone oil-coated pre-filled
      syringes. The results indicated that PS-80 prevented the formation of both
      protein and silicone oil particles. In the case of protein particles, PS-80 might
      involve in the interactions with the hydrophobic patches of protein, air bubbles,
      and the stressed surfaces of silicone oil-coated pre-filled syringes. Such
      interactions played a role in mitigating the formation of protein particles.
      Subsequently, quartz crystal microbalance with dissipation (QCM-D) was utilized
      to characterize the interactions associated with silicone oil, protein, and PS-80
      in the solutions. Based on QCM-D results, we proposed that PS-80 likely formed a 
      layer on the interior surfaces of syringes. As a result, the adsorbed PS-80 might
      block the leakage of silicone oil from the surfaces to solution so that the
      silicone oil particles were mitigated at the presence of PS-80. Overall, this
      study demonstrated the necessary of utilizing these three techniques
      cooperatively in order to better understand the interfacial role of PS-80 in
      mitigating the formation of protein and silicone oil particles.
FAU - Zheng, Songyan
AU  - Zheng S
AD  - Drug Product Science and Technology, Pharmaceutical Development, Research and
      Development, Bristol-Myers Squibb, New Brunswick, New Jersey, 08903, USA.
      [email protected]
FAU - Puri, Aastha
AU  - Puri A
AD  - Drug Product Science and Technology, Pharmaceutical Development, Research and
      Development, Bristol-Myers Squibb, New Brunswick, New Jersey, 08903, USA.
FAU - Li, Jinjiang
AU  - Li J
AD  - Drug Product Science and Technology, Pharmaceutical Development, Research and
      Development, Bristol-Myers Squibb, New Brunswick, New Jersey, 08903, USA.
FAU - Jaiswal, Archana
AU  - Jaiswal A
AD  - Biolin Scientific Inc, 215 College Road, Suite 300, Paramus, New Jersey, 07652,
      USA.
FAU - Adams, Monica
AU  - Adams M
AD  - Drug Product Science and Technology, Pharmaceutical Development, Research and
      Development, Bristol-Myers Squibb, New Brunswick, New Jersey, 08903, USA.
LA  - ENG
PT  - JOURNAL ARTICLE
DEP - 20160912
PL  - United States
TA  - AAPS J
JT  - The AAPS journal
JID - 101223209
OTO - NOTNLM
OT  - Archimedes
OT  - micro-flow imaging (MFI)
OT  - pre-filled syringe
OT  - protein particles
OT  - quartz crystal microbalance with dissipation (QCM-D)
OT  - silicone oil particles
EDAT- 2016/09/14 06:00
MHDA- 2016/09/14 06:00
CRDT- 2016/09/14 06:00
PHST- 2016/05/25 [received]
PHST- 2016/08/30 [accepted]
AID - 10.1208/s12248-016-9983-1 [doi]
AID - 10.1208/s12248-016-9983-1 [pii]
PST - aheadofprint
SO  - AAPS J. 2016 Sep 12.

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