Email: enquiries@bioventurescl.com

Regulatory Affairs & Product Development Services

The Application of Strong Scientific Understanding

Quality

One of the most important areas of biopharmaceutical development is the Quality section covering chemistry, manufacturing and control (CMC). BioVentures Consulting Limited has significant expertise in this area. For recombinant proteins, we can advise on the selection of the expression system, whether or not it is already well-established, and ensure cell banking issues relating to a regulatory filing are robust.

"We succeed by knowing your product and process, and then applying our regulatory and scientific expertise to find solutions"

BioVentures Consulting Limited can advise of the manufacturing process, and determine what can be done at manufacturing scale in terms of fermentation, centrifugation, cell disruption, chromatography, filtration and then scale this down for your pre-clinical production.

We succeed by knowing your product and process, and then applying our regulatory and scientific expertise to find solutions. BioVentures Consulting Limited can advise on the ICH data requirements for biopharmaceuticals relating to the manufacturing process in order to satisfy regulatory requirements that the manufacturing method is validated. Advise may include ensuring robustness of the genetic stability, cell substrates, viral safety, specifications, stability and comparability, as appropriate for the biological programme.

BioVentures Consulting Limited can advise on final product testing for biopharmaceuticals which typically may include sterility, potency (often an animal model for vaccines), purity testing, endotoxin, appearance, particular chemicals used in process, safety testing, uniformity of fill, protein content.

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