Pharmatek: Pharmaceutical Chemistry Development specializes in compound selection, analytical development and formulation development. Based in San Diego, Pharmatek is known for it's own Hot Rod Chemistry and Formulation Screening Kit.

Tools for Improving Process Quality and Robustness

As a drug substance moves through the individual phases of clinical trials and finally to commercialization, material requirements increase.  These increased demands often dictate a scale-up and/or technology transfer to a new facility or contract manufacturer.  

In order to streamline the implementation of a robust process that meets previously established specifications, a number of tools are available.  For example:

• Process controls to monitor critical process variables may significantly improve the quality of the final product and reduce out-of-spec (OOS) occurrences. 
• Technology transfer can be facilitated by assessing the operability of a process. 
• FMEA (Failure Mode and Effect Analysis) provides an invaluable tool for assessing and developing a plan to improve process robustness. 

The basis for the use of these tools is a multi-functional team that can assess, effectively communicate, and execute the tasks needed to move the project forward.   The QbD and PAT initiatives by the FDA provide a framework for some of the tasks at hand even if a company chooses to not fully implement these programs for their drug substance.

About the Speaker

Dagmar Meissner has been working in the Biotech Field for over 15 years.  Dagmar founded BioProcess Solutions in 2009, working as an independent consultant in the area of Process Development.  Prior to consulting, Dagmar worked with MicroIslet Inc. as Director of Process Development on the encapsulation of human and porcine Islets of the Langerhans for a cell-based therapy for diabetes.  Furthermore, she developed and scaled-up processes for the clinical manufacture of various therapeutics at CP Kelco, Pacira Inc., and Biogen IDEC including AVONEXTM, DepoCytTM, and DepoMorphineTM.

Her broad knowledge base includes a variety of biologics such as cell-based therapies, proteins, antibodies, biopolymers, and liposomes.  Her experience spans the spectrum of process development, from initial feasibility studies through GMP production for Phase III clinical studies including process design, optimization, and scale-up, equipment design, commissioning, validation, and technology transfer.