Managing Raw Materials in the QbD Paradigm, Part 1: Understanding Risks - An initial assessment of materials must extend beyond the material specification to include the supplier's manufacturing proce

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Managing Raw Materials in the QbD Paradigm, Part 1: Understanding Risks
An initial assessment of materials must extend beyond the material specification to include the supplier's manufacturing process, quality systems, and sourcing strategy.


BioPharm International
Volume 23, Issue 11, pp. 34-40

CHALLENGES ASSOCIATED WITH RAW MATERIALS USED IN BIOTECH PROCESSES


Table 1. Material categories used in bioprocessing. The list is not meant to be exhaustive but rather used for illustration.
Certain raw materials used in biotechnology processes are complex in nature as they often are not well-defined and known to exhibit lot-to-lot variability with respect to their impact on the process (for example, soy hydrolysate). There are a wide range of raw materials and components which have the potential to affect product quality or process performance. It includes process materials, process aids, materials contacting process fluids, excipients, devices, and primary and secondary packaging. A list of material categories is given in Table 1.

Some of the several key challenges that the biotech industry faces with respect to raw material management are:7

1. With respect to complexity of raw materials, a particularly challenging problem is that of the various components that are mixed to form the media for microbial fermentation or mammalian cell culture steps. A large number of such components are used, often a mix of chemically defined raw materials and complex raw materials such as hydrolysates.8 The performance of the process step is known to be sensitive to small changes in some of these components and even to changes in the procedure used to produce the media from them.

2. A typical biopharmaceutical manufacturer may have anywhere from 20–50 vendors that are sourcing raw materials for a given process. Because the manufacturer is legally responsible for the quality of the raw materials that it procures and uses, raw material management is a complex task.

3. Biotechnology processes are known to use a large number of different raw materials (typically 50–100). It is not feasible to examine the effect of each raw material experimentally.

Variability in product quality caused by variability in the quality of raw materials has been highlighted as a concern by the regulatory authorities. It is widely accepted now that a robust raw material management system must be in place to facilitate implementation of QbD. This is greatest towards the end of the process, where the effect on the drug product quality is significant.


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