Bioproduction

One of the emerging new headaches for bioanalytical departments is aggregation, its impact on immunogenicity, stability and efficacy. I’d be interested to hear your thoughts on this phenomenon, what underpins its mechanism and what analytical techniques are being developed to counteract its effects. Please give us your thoughts so that we can pass them on to our expert panel who will be dealing with the topic at this year’s Bioproduction event.

As I was researching our Quality by Design track for this years’ BioProduction PAT was a topic that many people wanted hear more about.  

Regulatory guidelines encourage biopharm manufacturers to implement PAT to improve and advance their process developments, in order to reduce time and cost in the whole production line.  However, there are aspects of the guidelines that are still unclear to many. Industry do not know when and where to implement PAT and what technology platforms to use. 

Have you successfully implemented PAT into your production system? 

If so please share your experiences with us as I found that very few people have practical experience with this and true case study material.  

Where does PAT fit with the lifecycle initiative and Quality by Design? 

Does it sit alone or fit in the whole system? 

I look forward to hearing your thoughts on this hot topic.  

Gemma Burns

Today, nearly 97% of biopharmaceutical manufacturers use single-use technologies. Not only are manufactures implementing single-use technologies, but also the range of applications for which these technologies are being used is expanding. Recent innovations have made a wider range of single-use technologies available for most downstream purification applications and production scales. Disposable systems for bioprocessing have come a long way over the last few years – indeed integration of these systems within manufacturing plants has become quite a talking point in the industry. Companies have come to recognise the significant benefits of disposables – no cleaning and cleaning validation, faster turnaround, shorter time to market, reductions in both capital & operating costs. 

The aim of the Disposable conference at BioProduction is to answer many questions with regards to implementation of this technology. Learn from industry experts and end-users who will share their experience. 

Are you using disposables in your manufacturing site and if so what problems if any have you encountered?

Louisa Maitland (Please note new married name)

New to this year’s Bioproduction is Protein Characterisation, a co-located event focusing on protein aggregation, impurities, glycan analysis and analytical strategies. As the conference producer I thought I’d give you an insight into some of the issues mentioned during my research.

Biopharma has a host of analytical tools at its disposal, from HPLC and Mass Spectrometry, to CE and AUC. However, no one technique is enough and companies must battle with the dilemma of choosing which technique to use, when and how to use it.

The main problem is that there is no real form of standardisation, with industry left with the unenviable task of filling in the blanks – and there are a lot of them. Like all successful business the key is in the planning – choosing which technologies to outsource or bring in-house, encouraging interactions between analytical and formulation departments from the start and validating methods in line with international regulations.

Analytical managers, like those at the very top, must formulate an strategy early on, decide which technologies are needed and invest appropriately. Then, once the data is generated, turn this information into tangible results that meet both commercial and scientific end-points.

This is why sharing information at events like Bioproduction is so important; understanding what techniques are working, what aren’t and where to focus your research.  I’d be very interested to hear your opinions on this and what you feel are the main bottlenecks and challenges impacting protein characterisation. I look forward to hearing your thoughts.

– Daniel Barry

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.

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, 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.