We (myself & 5 team mates from marketing & our R&D group) recently interviewed 30+ customers in leading biotechnology & biopharmaceutical manufacturers. All of these individuals came from companies that have active development pipelines with new bio-molecules and also have existing biopharm products approved and on the market.
I was interested in determining what products/services these customers were interested in from a bio-developer/manufacturers point of view. And more specifically, from a Company like us that provides services like these to biopharm companies utilizing cell culture as their production platform. Further, we were interested in what we could do from a technical perspective to enhance their experience with us as a vendor or partner (the latter being our preferred relationship).
The number one item selected by these customers – whether they were in the process development, manufacturing, or quality function – was that they wanted better characterization of raw materials in the products that we sold them. Usually customers were talking about cell culture media & feeds in this context but in other cases may have been considering other parts of the process downstream from the bioreactors.
What did better characterization actually mean?
Like most things in this industry that varied by customer. However, certain themes did emerge.
1.Know how the raw material/component performs in your product & how changes in that raw materials might effect that product’s performance
2.Know how changes in a raw material might effect performance of your (my) product with my [customer’s] production system & ultimately their end product
3.Understand key performance criteria of each raw material
4.Understand critical specifications for that raw material as relevant to end user applications not necessarily only to a pharmacopoeia standard for example
5.Provide both analytical testing results and biological performance & correlate the two in a meaningful fashion related intended application
6.Understand issues around chemical forms (e.g. free base or salt) and physical forms of the material (powder, liquid, concentrate)
7.Provide information around manufacturability (e.g. how solubility characteristics might effect this)
8.Provide information around compounding (i.e. ability to include component in a formulation and how to do that so that is stable and effective)
Raw material characterization was cited as an opportunity that every supplier in the industry could improve upon. Every customer I spoke to indicated they would like to see more work done in this area and more transparency around the resulting data/knowledge base. Clearly, customers would also like to see this concept integrated with the whole supply chain management around raw materials.
Based on this feedback, we have embarked on a “Raw material characterization” initiative. I would like to spend the next several posts describing some of our approaches and early observations.
Posted: Bruce Lehr, Jan 1, 2010