Bioproduction

As we approach the second half of 2008, is your understanding of the industry buzz word, Quality by Design (QbD), better than it was this time last year?

Gemma Burns — Thu, 03 Jul 2008 09:35:30 +0000

Hi my name is Gemma and I produced our Quality by Design track.

* Quality by Design * Process Analytical Technologies * Design Space * Systems Biology * Manufacturing Space * Quality Risk Management

With many of these concepts being relatively new to the biopharmaceutical industry one question that arose continuously throughout my research was:

How do all these fit together?

Harmonising these concepts is an extremely challenging task but it is one that I think industry are beginning to have to face. They know that the quality outcome must be designed into the process itself rather than relying on final product testing. This means that manufacturers are having to make larger investments earlier in the product life cycle during process development, in advance of approved commercial operations. It is clearly an important issue that, if implemented correctly could help to save valuable resources.

The single hottest topic from my research on Quality by Design was design space and upstream processing. What are the best ways to classify the parameters and control terminology? How does your company establish the appropriate design space during upstream processing and what are the advantages of this?

I hope that some of you will share your thoughts and discuss ideas for moving forward with process design and control.

Banishing the Bottleneck

pickeringl — Fri, 13 Jun 2008 10:15:13 +0000

Whilst researching into the current Antibody Production and Downstream Processing 2008 programme I spoke to several people in the Industry. The main challenge that was mentioned is the on-going issue with improving DSP (downstream processing) to fit the increasing USP-product titres. People are keen to know what is being done and who is looking at trends and new methods to solve this issue. What are the latest chromatography methods and column material being used? What options are available for the design of different materials? Are you replacing Protein A or abandoning it all together? The upstream-downstream gap is widening at an alarming rate. New technologies will have to be found and some old technologies will have to be reinvented. To meet the demands a comprehensive strategy is needed for process development. The bioprocessing industry has worked its way into a corner that seems to vindicate the adage, “be careful what you wish for, because you might get it.” As fields of protein per litre of cells spiral through the roof, there appear to be little way that the purification end of bioprocessing can keep in a cost-effective manner. Indeed the per kilogram cost of protein A now runs into millions of dollars.

What are your views and how is your company tackling this ever increasing problem?

Well next week is a short week for me; I’m getting married on Friday so you’ll soon see a change in my surname from
Pickering to Maitland. I’ll write again in a few weeks when I’m back from my surprise honeymoon.

Welcome to the BioProduction Blog

Kye Ling Gan — Fri, 09 May 2008 15:26:35 +0000

Welcome to the BioProduction blog, dedicated to facilitating discussion amongst industry about the advances in biopharmaceutical production, manufacturing and advances in the field. You can talk about your problems, challenges, general grievances, or anything you want to get off your chest. The blog will be written by the Conference Producers (Louisa Pickering, Gemma Burns and Dan Barry) and Kye Ling Gan the Marketing Manager and speakers at the meeting. We encourage anyone to comment.

As time goes by we hope to build up a blog that not only provides an interesting read in terms of scientific content, but also gives you information and news about the conference. After the conference we’ll post up photos and news of the event.