Do’s and Don’ts for Process Development

With speed and flexibility also at the top of the priority list when it comes to biomanufacturing, it’s clear why single use systems have seen such growth in recent years. However, streamlining your biomanufacturing facilities, managing suppliers and achieving operational excellence are all still areas where much change and improvement is needed. In this Pharma IQ interview, Dr. René Brecht, Vice President of Process Science and Manufacturing at ProBioGen, shares his insights on the disposable bioreactors market and implementing disposable biomanufacturing systems. 

Why have an increasing number of disposable bioreactors entered the market?

Disposable bioreactors offer an high level of flexibility and safety combined with low capital investment. The simple replacement of the culture ware minimises the plant validation efforts and reduces unit operation times. Extensive cleaning and cleaning validation procedures are eliminated.

Why and how should disposable solutions for biomanufacturing be evaluated?

The main advantages of the disposable solutions are prescribed above. To evaluate disposables, the following questions should be answered:

1. Is the available scale sufficient for your needs?
2. What are the disposables used for. Advantages like higher degree of flexibility are more desired for process development and multi product production. For the routine production of a market product cost of goods versus investment costs should be considered.
3. For large scale production, the availability of a scale down model is important to investigate unexpected events during production.
4. What is the supplier situation (robust quality, technical support, alternatives)?
5. What is the quality and robustness of the system (charge to charge consistency, leachables, comparability to non-disposable systems)?
6. What unique challenges still exist for the industry in biomanufacturing?

The main challenges are still costs, development time and safety.

What are the effects of single-use systems on the biopharmaceutical industry?

Single-use systems reduce the investment costs, save time and increase the safety.

What would be your do’s and don’ts of process development?

Efficient process development needs the following things:

1. small scale screening devices
2. efficient up-scaling strategies
3. lots of analytics, especially the understanding of structure-activity relationship
4. platform processes (e.g. for antibodies) to safe time
5. parallel work (upstream, downstream, analytics, formulation..)

Don’t spend too much time to get the most out of it. Don’t miss bioassay development to support the clone and process decisions.  
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Interview conducted by Andrea Charles.