Data Traceability - The Key to Successful R&D to Production for the Pharma Industry

Improved diagnosis is driving precision in treatment, accompanied by increasing regulation stringencies from the likes of the MHRA and FDA. This, in turn, ensures processes as well as the products themselves, are fully understood during every step of the manufacturing process.

The requirement for both the R&D and production processes to be ‘data-rich’ has become a pre-requisite for pharmaceutical product manufacturers, and purchasers alike; a phenomenon driven not only when things go well, but where an irregularity might have occurred, even when confirmed to be within the validated ‘Design Space’ parameters.

Where the products are invariably expensive to manufacture, manufacturers are always keen to use the data to prove, even if an irregularity took place, the batch can still be released rather than simply quarantined and/ or rejected. From a regulatory perspective, the above method of data interpretation and auditing for corroborating a product is safe for release, is also hugely beneficial.

Data Traceability from R&D to GMP Production

The freeze dryers supplied by Biopharma Group across the UK, Ireland and France, have been designed to put data traceability and scalability at the forefront of the development and includes a suite of lyo/freeze drying technologies by SP Scientific named Line of Sight™.

Line of Sight™ encompasses process analytical technologies (PAT), designed to assist pharmaceutical developers/ manufacturers in achieving drug commercialisation objectives, whether for scale-up or scale-down.

All aspects of the range are designed for use at R&D scale but are capable of use up to and including full GMP production too. This allows scientists to know from the outset of an R&D programme that the technology can be scaled up successfully - it is imperative technology can work at the commercial scale, as well as R&D.

To discuss your requirements, please contact Biopharma Group’s freeze dryer specialists today.

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