Application of the Risk Evaluation Matrix as per USP <665> and <1665> for Evaluation of Leachables Risk from Single-Use Components Used in Biomanufacturing Determining E&L risk from single-use components can be used to build the level of extractable profiling and PERLs.

Ramesh Raju Mavuleti; K. Vasantakumar Pai; K. Sreedhara Ranganath Pai; Subhasis Banerjee; Somasundaram Gopalakrishnan; Tathagata Ray

Application of the Risk Evaluation Matrix as per USP <665> and <1665> for Evaluation of Leachables Risk from Single-Use Components Used in Biomanufacturing Determining E&L risk from single-use components can be used to build the level of extractable profiling and PERLs.

Ramesh Raju Mavuleti^*
, K. Vasantakumar Pai
, K. Sreedhara Ranganath Pai
, Subhasis Banerjee
, Somasundaram Gopalakrishnan
, Tathagata Ray

^*Corresponding author for this work

Research output: Contribution to journal › Comment/debate › peer-review

Original language	English
Pages (from-to)	27-31
Number of pages	5
Journal	BioPharm International
Volume	37
Issue number	6
Publication status	Published - 2024

All Science Journal Classification (ASJC) codes

Biotechnology
Pharmaceutical Science

Cite this

Mavuleti, R. R., Vasantakumar Pai, K., Sreedhara Ranganath Pai, K., Banerjee, S., Gopalakrishnan, S., & Ray, T. (2024). Application of the Risk Evaluation Matrix as per USP <665> and <1665> for Evaluation of Leachables Risk from Single-Use Components Used in Biomanufacturing Determining E&L risk from single-use components can be used to build the level of extractable profiling and PERLs. BioPharm International, 37(6), 27-31.

Mavuleti, Ramesh Raju ; Vasantakumar Pai, K. ; Sreedhara Ranganath Pai, K. et al. / Application of the Risk Evaluation Matrix as per USP <665> and <1665> for Evaluation of Leachables Risk from Single-Use Components Used in Biomanufacturing Determining E&L risk from single-use components can be used to build the level of extractable profiling and PERLs. In: BioPharm International. 2024 ; Vol. 37, No. 6. pp. 27-31.

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author = "Mavuleti, \{Ramesh Raju\} and \{Vasantakumar Pai\}, K. and \{Sreedhara Ranganath Pai\}, K. and Subhasis Banerjee and Somasundaram Gopalakrishnan and Tathagata Ray",

year = "2024",

language = "English",

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Mavuleti, RR, Vasantakumar Pai, K, Sreedhara Ranganath Pai, K, Banerjee, S, Gopalakrishnan, S & Ray, T 2024, 'Application of the Risk Evaluation Matrix as per USP <665> and <1665> for Evaluation of Leachables Risk from Single-Use Components Used in Biomanufacturing Determining E&L risk from single-use components can be used to build the level of extractable profiling and PERLs.', BioPharm International, vol. 37, no. 6, pp. 27-31.

Application of the Risk Evaluation Matrix as per USP <665> and <1665> for Evaluation of Leachables Risk from Single-Use Components Used in Biomanufacturing Determining E&L risk from single-use components can be used to build the level of extractable profiling and PERLs. / Mavuleti, Ramesh Raju; Vasantakumar Pai, K.; Sreedhara Ranganath Pai, K. et al.
In: BioPharm International, Vol. 37, No. 6, 2024, p. 27-31.

Research output: Contribution to journal › Comment/debate › peer-review

TY - JOUR

T1 - Application of the Risk Evaluation Matrix as per USP <665> and <1665> for Evaluation of Leachables Risk from Single-Use Components Used in Biomanufacturing Determining E&L risk from single-use components can be used to build the level of extractable profiling and PERLs.

AU - Mavuleti, Ramesh Raju

AU - Vasantakumar Pai, K.

AU - Sreedhara Ranganath Pai, K.

AU - Banerjee, Subhasis

AU - Gopalakrishnan, Somasundaram

AU - Ray, Tathagata

PY - 2024

Y1 - 2024

UR - https://www.scopus.com/pages/publications/85197239260

UR - https://www.scopus.com/pages/publications/85197239260#tab=citedBy

M3 - Comment/debate

AN - SCOPUS:85197239260

SN - 1542-166X

VL - 37

SP - 27

EP - 31

JO - BioPharm International

JF - BioPharm International

IS - 6

ER -

Mavuleti RR, Vasantakumar Pai K, Sreedhara Ranganath Pai K, Banerjee S, Gopalakrishnan S, Ray T. Application of the Risk Evaluation Matrix as per USP <665> and <1665> for Evaluation of Leachables Risk from Single-Use Components Used in Biomanufacturing Determining E&L risk from single-use components can be used to build the level of extractable profiling and PERLs. BioPharm International. 2024;37(6):27-31.

Application of the Risk Evaluation Matrix as per USP <665> and <1665> for Evaluation of Leachables Risk from Single-Use Components Used in Biomanufacturing Determining E&L risk from single-use components can be used to build the level of extractable profiling and PERLs.

All Science Journal Classification (ASJC) codes

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