| Author | Title | Year | Company (Country) | Reftype | Comments |
|---|---|---|---|---|---|
| Muranyi, A. | Process intensification with ready-to-use and single-use systems: downstream processing of a monoclonal antibody [Abstract] |
2010 | GE Healthcare Bio-Sciences AB (Sweden) | standard | |
| Abstract:Increased focus on productivity in biopharmaceutical manufacturing has led to a larger demand for disposable process solutions. ReadyToProcess is a family of products including systems, columns, and membranes for plug- and play alternatives. The product range is developed to achieve operational excellence by enabling LEAN manufacturing. In this presentation, a monoclonal antibody process, from cell culture to final formulation, provides a basis for comparison of a fully ready to use process with a traditional stainless steel process. Process time, contaminant and aggregate removal are studied in detail. | |||||
BibTeX:
@standard{Muranyi2010,
author = {Andreas Muranyi},
title = {Process intensification with ready-to-use and single-use systems: downstream processing of a monoclonal antibody},
journal = {GE Healthcare Bio-Sciences AB (Sweden)},
year = {2010}
}
|
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| Rachon, A. | Simplifying formulation and filling operations with single-use technology: a breakthrough in aseptic processing [Abstract] |
2010 | MILLIPORE S.A.S (France) | standard | |
| Abstract:Well established since a few years for non critical fluid handling applications, single-use technologies are now entering into the complex formulation & filling operations. Based on a vaccine manufacturer case study, the presentation will describe why single-use configuration was considered versus hardware design for a full aseptic processing build. The remarkably fast process integration as well as the critical step of fluid transfer across the sterile barrier (Isolator or Restricted Access Barrier Systems - RABS) via an alpha/beta transfer port will be discussed. After almost one year of process runtime, a first assessment (benefits review) will be drawn regarding its productivity and economical gains. | |||||
BibTeX:
@standard{Rachon,
author = {Alain Rachon},
title = {Simplifying formulation and filling operations with single-use technology: a breakthrough in aseptic processing},
journal = {MILLIPORE S.A.S (France)},
year = {2010}
}
|
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| Zambaux, J.P. | A new service for the biotech / pharma industry: Single-use fill and finish [Abstract] |
2010 | Disposable-Lab SAS (France) | standard | |
| Abstract:Disposable?lab had launched the first” Plastic “factory for the final filling of sterile drugs in Bordeaux –France to serve the Pharma and Biotech industry The concept is based on new disposable Isolator which allow to weight to fill and to cap and with a modular concept for the clean room. To produce drugs for phase 1 to 4 require a validated processing. This will help you to get from the pharmaceutical authority, an agreement to supply such drug for human use. Clinical Batches is different from the commercial manufacturing. Each product and each active ingredient are new and not well?known. The cleaning and cleaning validation between each batch is long and difficult to do, specially for bio product. Some manufacturing as oncologic product require too dedicated manufacturing tools. Disposable is the solution. To reach that goal there is a lot of points which had to be solved. How to work on a close system? How to introduce pyrogen free vials? How to protect the operator by working under pressure on disposable?...Those points will be developed and presented. | |||||
BibTeX:
@standard{Zambaux2010,
author = {Jean Pascal Zambaux},
title = {A new service for the biotech / pharma industry: Single-use fill and finish},
journal = {Disposable-Lab SAS (France)},
year = {2010}
}
|
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| Zarbis-Papastoitsis, G. | Process considerations for clarification and downstream processing of high titer and high cell density PER.C6® harvests using single-use technologies [Abstract] |
2010 | PERCIVIA, LLC (USA) | standard | |
| Abstract:Advances in single-use technologies enable greater speed, flexibility, and a smaller footprint for biologics manufacturing facilities. In a disposable scheme, traditional chromatography column operations are replaced with adsorptive membranes or other non-traditional purification methods. The purification steps implemented in a fully disposable process should meet the requirements of low cost, easy implementation and operation, and scalability. In this study, a disposable downstream process was developed for the clarification and purification of a monoclonal antibody expressed in PER.C6® suspension cell culture. The cell culture harvest was clarified by enhanced cell settling (ECS™) and optimized depth filtration. The monoclonal antibody was further purified by a combination of single-use technologies and finally concentrated by ultrafiltration/diafiltration. The product recovery was 63% and the HCP reduction was 3.7-4.1 LRV for two different scales. The economics of the single-use technologies process were compared to a traditional manufacturing process using cost model analysis. | |||||
BibTeX:
@standard{Zarbis-Papastoitsis2010,
author = {Gregory Zarbis-Papastoitsis},
title = {Process considerations for clarification and downstream processing of high titer and high cell density PER.C6® harvests using single-use technologies},
journal = {PERCIVIA, LLC (USA)},
year = {2010}
}
|
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Created by JabRef on 23/03/2010.