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AboutIntroducing Enbrel®Heritage of Enbrel®IndicationsTherapeutic IndicationsRheumatoid ArthritisJuvenile Idiopathic ArthritisPsoriatic ArthritisAxial SpondyloarthritisPsoriasis & Paediatric PsoriasisMechanism of actionMode of ActionHalf-lifeDosingDosingRheumatoid Arthritis, Psoriatic Arthritis & Axial SpondyloarthritisJuvenile Idiopathic ArthritisPsoriasisPaediatric PsoriasisAdministration & StorageAdministrationMYCLIC®StorageEfficacy & SafetyEfficacyRapid EffectivenessSustained EffectivenessEffectiveness With Monotherapy or Combination TherapySafetyTolerability Across IndicationsSummary of Prescribing InformationImmunogenicityImmunogenicity & Clinical ResponseImmunogenicity & Enbrel®Experience & InsightsExperience & InsightManufacturingPatient StoriesRheumatoid ArthritisPatient With an Increased Risk of Serious InfectionsMTX-IR PatientPatient Who Is Considering Starting a FamilyElderly-onset RA PatientYoung Patient Worried About the Lifelong Impact of RAYoung Patient Worried About Treatments That Lose Effectiveness Over TimeJuvenile Idiopathic ArthritisJuvenile PatientPatient Moving From Childhood to AdolescenceAxial SpondyloarthritisAS Patients With Heel EnthesitisAS Patients With Functional LimitationsAdvanced AS PatientsPsoriatic Arthritis & PsoriasisPsO Patient With Severe SymptomsPsO Patients With Cyclical SymptomsPsA Patient With Metabolic SyndromePsA Patient With Multiple Skin & Joint SymptomsSupport & ServicesSupport & ServicesUsing Enbrel®Summary of Prescribing InformationPatient ResourcesEventsMaterialsVideos

Manufacturing

Patient access to Enbrel® starts with a complex and highly controlled manufacturing process1,2

  • Manufacturing of Enbrel® has consistently used the same cell bank for 20+ years over 2500+ batches
     
  • Each batch of Enbrel® has a >40-day manufacturing process
     
  • More than 20 testing procedures and over 100 quality control tests are performed on each batch of Enbrel®

From 1998 to 2015, Enbrel® was subject to 20 manufacturing improvements,3 none of which had impact on efficacy/safety.3,4

    

    

References:

Data on file. Manufacturing story. Pfizer. 2016.Data on file. Enbrel testing expert statement. Pfizer. 2018.Hassett B, Singh E, Mahgoub E, O'Brien J, Vicik SM, Fitzpatrick B. Manufacturing history of etanercept (Enbrel): consistency of product quality through major process revisions. MAbs. 2018;10(1):159-165.Weinblatt ME, Bathon JM, Kremer JM, et al. Safety and efficacy of etanercept beyond 10 years of therapy in North American patients with early and longstanding rheumatoid arthritis. Arthritis Care Res (Hoboken). 2011;63(3):373-382.

    

Please click the Prescribing Information link to view the safety and adverse events information of Enbrel®.
For the use only of Registered Medical Practitioners or a Hospital or a Laboratory.

    

PP-ENB-IND-0814 August 2022

    

    

Experience & Insights

    

Badge Analysis of Manufacturing Process Changes

Review a recent study that assessed the product quality of Enbrel® through 3 major manufacturing enhancements from 1998 to 2015

 Watch the videoLoading

    

Badge Evaluation of current manufacturing process

Review a recent study that assessed the immunogenicity, safety and efficacy of Enbrel® produced with its current, serum-free, high-capacity manufacturing process

       

 Watch the video Loading
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These pages are not intended for patients or for members of the general public. The web pages contain promotional content. For the use only of Registered Medical Practitioners or a Hospital or a Laboratory. Full prescribing information available on request. For more details on, Who is a Registered Medical Practitioner, please visit "https://cdsco.gov.in/opencms/export/sites/CDSCO_WEB/Pdf-documents/acts_rules/2016DrugsandCosmeticsAct1940Rules1945.pdf", Page No. 39, Rule 2 part (ee), last accessed on 26th April2021.
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Address: The Capital,  A Wing, 1802, 18th Floor, Plot No. C-70, ‘G’ Block, Bandra Kurla Complex, Bandra East, Mumbai – 400051, India.
 
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These pages are not intended for patients or for members of the general public. The web pages contain promotional content.

 

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For more details on, Who is a Registered medical practitioner*, please visit "https://cdsco.gov.in/opencms/export/sites/CDSCO_WEB/Pdf-documents/acts_rules/2016DrugsandCosmeticsAct1940Rules1945.pdf", Page No. 39, Rule 2 part (ee), last accessed on 26th April 2021.
Address: The Capital, A Wing, 1802, 18th Floor, Plot No. C-70, 'G' Block, Bandra Kurla Complex, Bandra East, Mumbai - 400051.


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