Process Development and Manufacturing: Single Use Versus Glass and Stainless Steel

Pharmaceutical Discovery, Development and Manufacturing Forum
AIChE Annual Meeting
November 7, 2013 - 3:15pm-3:40pm
Single-use equipments are now commonly used for process development and production activities. The advantages of these equipments have been well demonstrated over more than a decade and include absence of cleaning , no need for sterilization , easy and fast validation , reduced labor time and increased flexibility. However , only a few data on their scalability are published and most studies focus on a single type of equipment such as Single-Use Bioreactors (SUBs) or on DSP units such as clarification or chromatography skids. Few studies actually describe full USP and DSP disposable trains.During the period 2010-2012 , we performed studies in order to evaluate the performances of Single-Use equipments from early Process Development activities down to the manufactured Drug Substance after a full manufacturing process. As different formats were available , this study compared performances of several types of equipments from 3L to 1250L scale. The evaluation was performed both for Process Development applications and for clinical material production through the development of a fed-batch process and its use for clinical scale production.The quality of the molecule together with the titer and the cell growth were measured. The process performances were compared in single use , glass and stainless steel bioreactors of different sizes including 3L , 50L , 200L and 1 ,250L. Several clinical runs at 200L and 1250L scale were performed to ensure a meaningful comparison. We evaluated the differences between the systems using different types of cells such as CHO and NS0 but also different molecules including several MAbs and Fc-Fusion protein. The data generated allowed to conclude on the scalability and the comparability of the different systems and technologies. Beyond the process performances and technical data we recorded timings and evaluated the cost of the different operations to complete the assessment.This study demonstrated the benefits of using disposable equipment in several key areas. The comparison of stainless steel , glass and disposable equipment showed how comparable they are regarding titers , molecule quality…and how different they are regarding organization and financial aspects. The operator feedbacks on the ease of use and the necessary changes in the GMP area to introduce SUBs were discussed as well.  
Professional Development Hours
0.5 PDHs
You will be able to download and print a certificate for these PDH credits once the content has been viewed. If you have already viewed this content, please click here to login.
Presenter(s): 

Would you like to access this content?

No problem. You just have to complete the following steps.

You have completed 0 of 2 steps.

  1. Log in

    You must be logged in to view this content. Log in now.

  2. Purchase Technical Presentation

    You must purchase this technical presentation using one of the options below.
    If you already purchased this content recently, please click here to refresh the system's record of ownerships.

Pricing

Credits 0.5 Use credits
List Price $25.00 Buy now
AIChE Members $15.00 Buy now
AIChE Undergraduate Student Members Free Free access
AIChE Graduate Student Members Free Free access
Related Topics: 
Skill Level: