Expert Areas for Bo Forsberg Biotech

Downstream Process Design

Design of a full process have been a great interest of mine for many years and is also part of my teaching in chromatography at UCL (University College London).

Organizing the purification train and how many sub lots to run can greatly improve both purification and cost. I have also created tools that explain and guide in this matter.

It is important to design the full process for scalability, cost effectiveness and performance giving a process with high yield, high purity and low cost of goods.

I will show You the way to meet all your goals.

Engineering for full and optimal control

The design of the equipment for both chromatography and tangential flow filtration (cross flow, flat sheet or hollow fibre) systems are highly important for achieving the purification quality needed at the appropriate cost of goods.

A false design may easily distort a fine tuned separation in chromatography or clog membranes or hollow fibres prematurely.

I have tools and knowledge to enhance your process till low risk and high profit.

Trouble Shooting for issues in both processes and process skids

My main tasks lately are in trouble shooting and root cause finding.

The trouble shooting, I conduct is mainly regarding column packing, chromatography and tangential flow filtration processes and equipment.

UNICORN Programming

I have great knowledge in programming UNICORN methods for both chromatography and TFF. UNICORN was developed at the process laboratory at Amersham Pharmacia Biotech (APB). I was part of this development and performed high level training in UNICORN programming for customers of APB.

Column Packing Development (all types of resins in all types of columns at all sizes)

I have gathered all kinds of information in how to pack all sorts of resins in any odd types of columns. This also applies for combinations that are not applicable as both resins and columns are rated in HPLC, MPLC and LPLC based mainly on pressure tolerance for the media in relation to the column construction.

There are great rules of thumbs to rely on and also a need to understand both resin and column limits to create a well-functioning packed bed with a long life time.

Risk Assessment

Risk assessment (RA) is a process for understanding challenges in any processes.

I can provide with a tool for RA together with instructions and I also can interact in creating a risk assessment for any process.

URS / FS / DS / FAT / SAT / IQ / OQ and PQ

For all equipment it is necessary to establish documents defending the use.

The V-model described in the ICH-guidelines should be followed and this tells that the functionality should be described in URS, FS and DS (user requirement specification, functional specification and design specification) and tested through FAT, SAT, IQ, OQ and PQ (factory acceptance test, site acceptance test, installation qualification, operational qualification and performance qualification).

I have used this model for specifying, acquiring, and qualifying equipment for both chromatography and tangential flow filtration many times to ensure process functionality.

Process Validation

Over the years I have been part of and designed process validation for several clients.

In both chromatography and tangential flow filtration there are key parameters to set acceptance criteria for.

Resin Lifetime Validation

Resin lifetime validation is a rather new requirement from authorities demanding demonstration of resin lifetime for use and cleaning of resins at process scale. I have planned and conducted resin lifetime validation for several chromatographic steps used in commercial manufacturing.

cGMP for clever and safe manufacturing

As being part of cGMP manufacturing for all sorts of processes including microbial, picha, hybridoma, insect and mammalian I have acquired a great knowledge in what is needed to meet current requirements for all sorts of biotechnical manufacturing.