Downstream bioprocess scale-up and technology transfer

Be one step ahead in preparing for future GMP production

Transferring a process from a laboratory-scale idea to GMP-compliant commercial product is a resource-intensive step in biomanufacturing.

Let us help you find a way to make this transition less demanding.

Ensure a robust bioprocess outcome

Good process understanding is key to ensure low variability, and careful selection of raw materials enables a secure long-term supply of downstream process components.

Develop processes that account for variation and plan for robust GMP production from start.

Obtain a smooth scale-up to manufacturing

Understanding the impact of process equipment on product quality is important for a successful tech transfer from process development to the production hall.

Learn about a successful 100-fold scale-up of a mAb process from laboratory to process scale.

Inline conditioning buffer management system

Blog

Chromatography scale-up: don’t get tied down by bed height

April 23, 2018

When scaling, you can make better use of existing chromatography columns while avoiding overcapacity. Try this alternative approach to achieve a constant residence time.

Knowledge Article

Adapting single-use chromatography to manufacturing scale

While single-use technologies are widely adopted in upstream processes, what is required to move single-use technologies into downstream manufacturing scale?

Blog

Start with the end in mind—GMP tech transfer

November 22, 2017

How can you be one step ahead in process development and prepare for future GMP work? Learn what tech transfer experts say about this. And discover how to apply their approach to your process.

Increase speed to GMP production

Utilizing your supplier’s expertise can aid in rapidly establishing and maintaining a biopharmaceutical GMP process.

Use vendor data on, for example, material compatibility and cleaning procedures for preparation of SOPs and stay current with change control notifications.

Maintain competitiveness with novel process strategies

Balancing technologies to gain manufacturing excellence is key. Inline conditioning can ease buffer bottlenecks, the right combination of single-use and reuse options can improve cost-efficiency.

Keep up-to-date with current trends and technologies to maintain a competitive edge.

Get technology transfer support

We help bioprocessing teams to transform an idea into results, with great flexibility and confidence, reducing costs and time to market.

Get support along the way to a cost-effective manufacturing that meets current regulatory demands from our Fast Trak Services team.

Scale-up and tech transfer

Be one step ahead in preparing for future GMP production

Ensure a robust bioprocess outcome

Obtain a smooth scale-up to manufacturing

Increase speed to GMP production

Maintain competitiveness with novel process strategies

Get technology transfer support

AxiChrom platform

ReadyToProcess column platform

ÄKTA pilot 600

Inline conditioning system