Enbrel Manufacturing Case Study

INTRODUCTION

Enbrel 50 mg is a 50 mg solution for injection in a single used pre-filled pen. It is used for the treatment in adult and juvenile patients of Rheumatoid arthritis, Juvenile idiopathic arthritis, Psoriatic arthritis, axial spondyloarthritis, Ankylosing spondylitis (AS), Non-radiographic axial spondyloarthritis, Plaque psoriasis, Paediatric plaque psoriasis.
In combination with methotrexate, Enbrel can be used for the treatment of moderate to severe active rheumatoid arthritis in adult patients when the response to disease-modifying antirheumatic drugs, including methotrexate has been inadequate.
Alone or in combination with Methotrexate, Enbrel has proven to reduce the rate of progression of joint damage and to improve physical …show more content…
Phase 2: Basic Design
Process and instrumentation diagrams

3. Phase 3: Detailed Design
Detailed Architectural Drawings
Enbrel manufacturing facilities should be designed:
 To provide simple material and personnel work flows to minimise possibility of contamination of/ by the product(s)
 To fully contain and minimise areas where the product may be exposed
 To provide manufacturing facilities which are easy to clean, and prove clean, and which facilitate product changeovers
 To provide physical separation between different operations and stages of production
 To provide effective ventilation providing an adequate air quality in processing rooms to protect product and avoid cross-contamination
 To consider and address the needs of non-process activities (reception areas, amenity areas, provision for utility systems, provision for internal and external infrastructure requirements)
 To provide appropriate manufacturing facilities to enable visitors to view as much of the operation as possible whilst minimising the need for change procedures, e.g. via the use of viewing galleries and windows or CCTV systems

Design …show more content…
Critical Quality attributes (CQA) and Critical process parameters (CPP) of the planned manufacturing drugs should be taken into account during facility design. Product CQA’s and CPP’s need to be monitored/ controlled to avoid variability on the CQA.
Facility needs to directly assist in protecting the product. Critical areas should be defined during the design stage.
A better design of a facility will help reducing the possibility of contamination or to produce poor quality drug products.
 According to ISPE Baseline guide, Volume 6, “The elimination of the environment as a source of contamination can have a significant impact on facility design”
 “Facilities should be designed to allow operators to spend minimum time in processing areas – systematic approach relying on

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