Process Validation

Defining a capable manufacturing process

Process Validation is a pivotal lifecycle activity that involves the collection and evaluation of process data and knowledge to establish a defendable control strategy and defines a capable manufacturing process that reliably meets product quality attributes. This part of the product lifecycle leverages knowledge from early process development through to commercial manufacture and on-going supply chain maintenance. It is a vital component for the successful commercialization of biologic and vaccine products.

Process Validation typically follows Process Characterization in the product development cycle. FUJIFILM Diosynth Biotechnologies considers Process Validation to be a joint customer-company activity whereby we work together  towards the preparation and execution of a conformance campaign that will enable your Biologics License Application (BLA) activities and subsequent commercialization of your product.

With over twenty five validation campaigns completed within our network, we bring significant experience to our customers’ Validation Campaign.Our Process Validation activities begin in earnest with the drafting a Validation Master Plan (VMP), and associated process and cleaning validation protocols upon the completion of Process Characterization. We base the protocols on our experience with your process, including:

  • Process experience gained during technology transfer
  • Demonstration runs
  • Engineering runs
  • cGMP clinical supply runs
  • Process characterization data

Running your Conformance Campaign

Conformance batches will be run following the defined and agreed validation protocol each targeting the set points within the defined acceptable operating ranges. Typically, batches will be operated as end to end batches with limited or no overlapping. An extended set of in-process characterization testing is expected during validation to ensure that full characterization and control of your process can be demonstrated.

Cleaning validation is typically completed during conformance batch manufacture based on laboratory cleaning studies and previous experience with equipment cleaning in the manufacturing facility.

At FUJIFILM Diosynth Biotechnologies, Process Validation batches are produced with oversight by Quality Assurance, Process Sciences and Process Development personnel.