Overcoming the challenges of high concentration protein formulations

There is a trend within the biopharmaceutical industry for companies to develop formulations for protein drugs with extremely high concentrations. Such formulations provide advantages to both patients and clinicians as they allow biological drugs to be delivered via the sub-cutaneous route of administration rather than by the more traditional intravenous route. Sub-cutaneous delivery allows patients to receive treatment in a clinic or even administer the drug themselves while intravenous infusions tend to require the patient to make a hospital visit which increases the cost of treatment. However, if a patient is able to self-administer the pharmaceutical drug they require to treat a chronic disease then they are more able to lead a normal life which is a tremendous benefit (Highly concentrated protein formulations: Finding solutions for the next generation of parenteral biologics, J Kling, 2014).

The challenge of processing highly concentrated protein drugs

Being able to provide a biopharmaceutical at a formulated concentration of 100 g/L or higher can be a means by which biopharmaceutical companies can gain an advantage over one another in an increasingly competitive marketplace. However, developing such formulations is no trivial task because at high concentrations, protein solutions can become very viscous and difficult to process and the proteins themselves can aggregate. The viscosity of these solutions can challenge filtration equipment and can lead to significant yield losses in the final stages of the processes when the product has its greatest value. Protein aggregation can lead to a reduction in the pharmaceutical’s potency and can even trigger an immune reaction to the drug.

Innovation at the interface with formulations

The topic of high concentration protein formulations will be covered at the BioProcess International Conference & Exposition 2015 to be held on October 26-29 in Boston, MA. Sigma S Mostafa, PhD, Director, Process Development at KBI Biopharma Inc will be chairing a session on ‘Innovation at the Interface with Formulations’. Pfizer are scheduled to present on ‘Challenges of High Concentration Formulations – Dealing with Viscosity and Excipients’ while Mark Moody will present on ‘Opportunities and Challenges of High Concentration Biologics: Case Studies’. The session promises to address some of the key issues manufacturers face when processing concentrated protein solutions.

Have your say

Protein biopharmaceuticals are being formulated to 100 g/L even 200 g/L, however, some have proposed that concentrating to 500 g/L may be desirable. In your opinion, what is the maximum concentration that is required or attainable for protein drug formulations?

Dr Nick Hutchinson

Join me at #BPIconf

Contact me at nick.hutchinson@parker.com

Dr Nick Hutchinson has a Masters and Doctorate in Biochemical Engineering from University College London, UK where he focused on laboratory tools for rapid bioprocess development and characterization. He then worked at Lonza Biologics in an R&D function investigating novel methods for large-scale antibody purification before moving to an operational role scaling-up and transferring manufacturing processes between Lonza sites in the UK, Spain and USA. Nick now works in Market Development at Parker domnick hunter where his focus is in bringing Parker's strengths in Motion & Control to Bioprocessing. This will enable customers to improve the quality and deliverability of existing and future biopharmaceuticals.

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