On 19 May 2011, the EMA published a "Concept Paper on the need for a guideline on process validation of medicinal products containing biotechnology derived proteins of active substances".
For the EMA, it was necessary to develop a Guideline. Despite the existence of various documents which have been harmonised through the ICH process, guidance on the specific aspects of products derived from biotechnology processes as well as on the evaluation/validation has been missing.
Although the ICH Q5 and Q11 (Draft) Guidelines address some important concepts and aspects relating to the evaluation/validation of biotechnology derived proteins, there is no guidance on further aspects like impurity clearance of DNA or host cell proteins, column/membrane sanitisation, life time, hold time, reprocessing, pooling of intermediates and selection of batches which need to be included in the evaluation/validation studies. All these aspects are essential to understand the manufacturing process and to know the resulting products. This is important for the assessor during the marketing authorisation process, too.
The ICH Q8 - Q10 Guidelines - which currently need to be integrated in the routine activities of manufacturers and marketing authorisation holders - don't provide any advice on the necessary evaluation and validation studies for the aspects mentioned above. This affects both new applications and variations. For this reason, the Biologics Working Party (BWP) suggests developing a new guideline which takes into account existing recommendations. The BWP will be responsible for the elaboration of the Draft Guideline, too.
The deadline for comments to thisConcept Paper - which provides a template for comments - is 31 August 2011.
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)
PS. The ECA education course Vaccines & Biologics, on 22/23 November 2011 in Dessau-Roßlau will deal with the development, scale-up and manufacturing requirements on biotechnology derived products.