Daniella Steel presents Alternatives in Disposable Solutions at Biologics Manufacturing Korea 2021

Hello!

 Thank you for joining me in this presentation on alternatives and disposable solutions for bioprocessing columns brought to you by Astrea Bioseparations.

Just a few words about myself, I am Daniella Steel, Senior Product Manager at Astrea Bioseparations and I have been developing products and services for the pharmaceutical industry and for academia for over 15 years.

In today's presentation I am going to focus on why disposable chromatography columns are becoming more sought after in Bioprocessing.  

I will focus on how Astrea is addressing this need with two column ranges, one being a unique semi-disposable column and the other our custom pre-pack service for fully disposable columns and then I will go through a short study that demonstrates the consistency of Astrea’s disposable columns at scale.

But first I would like to give you a little background about our company, its name and what we stand for. Astrea the star maiden was the Greek goddess of justice, innocence, purity and precision. We took the name Astrea Bioseparations to reflect our own focus on purity, precision, and humanity in all we do. Our team actively supports customers with products and services that enable them to discover, develop and deliver therapies to the market that treat or potentially cure diseases. At Astrea Bioseparations every detail matters as we work to create tailored solutions that streamline bioprocesses from research to commercial phases.

Our range of products and services include off-the-shelf absorbents and columns as well as custom services to find and manufacture the optimal resins for your Bioprocessing needs.

We can make 1 000 Litre batches in our clean room environments, and we can supply the regulatory support so that you can use this in your GMP processes.

Astrea has a global presence with sites across the UK and North America and with distributors located across Europe and the APAC region.

So, discussing now the advantages of visible or campaign use columns:  

Many companies are experiencing increasing demands to reduce the costs, while increasing productivity and efficiency of their biomanufacturing processes.

Therefore, many are moving towards disposable solutions as these allow for greater ease of use. These can have a positive effect improving process economics as much of the cleaning and validation required can be eliminated.

Even though columns are inherently expensive due to the engineering required and the cost of the resin, there is an increasing trend to use disposable columns as these can mitigate the bottlenecks in downstream processing areas. In this case due to the resin costs disposable columns are potentially no single used but much more campaign use.

Some of the benefits of disposable columns include an increased operational speed as these are designed to plug and play.  This removes the need to clean and validate a column so saving both time and QA resources. These columns also provide operational flexibility facilitating rapid change overs to new product processes.

In addition, for pre-pack columns you obviously don't need to keep in-house resin packing expertise and this can be quite a burden for particularly smaller companies.

Another thing to note is that due to the nature of disposable columns these are usually not required to be larger than about 30 centimetres diameter and so they are much more adapted for continuous column chromatography market as well as supporting the smaller scale column requirements of personalized therapies.

 So with those benefits in mind, I would like to introduce you to Astrea range of semi-disposable columns - the Evolve range.

The Evolve column is an easy-to-use cost effective and ready to use pilot process scale column.

We offer seven different sizes from 70 to 350 millimetres inner diameters which all have a non-metallic flow path. We also have a larger 450-millimetre inner diameter column which is available now for testing.

These columns conform to the relevant regulatory requirements for manufacturing and is rated to four bars when operational.

The unique feature of these columns is the refresh kit which allows the customer to replace the wetted flow path, while retaining the column skeleton.

This not only reduces the amount of waste a customer has to handle but also reduces the cost as the refresh kit is approximately a third of the price of the column.

In addition to the semi-disposable evolve columns Astrea also provides the fully disposable ready-to-use pre-pack columns in our EvolveD range where the D stands for disposable.

So, EvolveD process columns are supplied pre-packed with media from Astrea's range of bioseparation products for applications such as protein purification and contaminant removal.

But we can also provide these as custom packed with a range of chromatography media types such as Agarose and Poly based adsorbents.

These are available in 70-, 100- and 200-millimetre diameters with bed heights options of either 100 or 200 millimetres.

Columns are packed in a GMP environment and supplied with certificates of analysis and regulatory support files.

One of the key features of these columns are that their sizes are very suited to continuous chromatography so providing a scalable platform from around 380 ml to over 6 litres.

Now will walk you through a short study that demonstrates the consistency of Astrea's disposable columns at scale. For this study we compared the efficiency of three column sizes in clearing endotoxin using EtoxiClear, our proprietary endotoxin removal adsorbent.

We used two of Astrea's research scale columns the 5 and 50 ml Evolv R columns as shown on the left and compare this performance to the larger disposable Evolve-D column.

As I mentioned the columns are tested using EtoxiClear with purified solution of IGG containing endotoxin.

EtoxiClear works in a negative mode with the IGG product passing through the column and the endotoxin being retained. Comparable amounts of IGG solution containing endotoxin were loaded onto each column. The flow-through material for all three formats exhibited high recoveries of IGG as seen in the green boxes and demonstrated greater than 4.5 log clearance of endotoxin to below 0.1 EU/mg of IGG.

These results show that the larger disposable EvolveD columns still gave the same high performance of the smaller scale columns.

So, in summary Astrea offers two solutions for customers wanting to benefit from the ease of use and cost reductions that come with disposable columns:

EvolveD range is a semi-disposable column with refresh kit that reduces column costs and the expense associated with waste removal and the EvolveD range on the other hand is fully disposable pre-packed and validated, a column ready for use.

Thank you very much for your attention and with that I would look forward to answering your questions.

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