Provide consulting services for development and progression of Validation Master Planning and Process Characterization activities.

Biopharmaceutical and biologics manufacturing process design, scale-up, validation, optimization and technology transfer services with strong focus on integration of QbD principals and PAT tools.Call: 346-440-1468Email: john.davis@etcbioprocessserices.com

Provide hands-on technical guidance for the start-up of large-scale fermentation of a clinical-to-commercial biologic,

Provide technical support for development of Method Validation Protocols for PAT implementation in a cGMP manufacturing environment at client company.

Supporting the development of a Process Characterization Program at client company.

Process validation towards commissioning of new biologics manufacturing facility..

Applied technical expertise toward feasibility assessment of establishment of biologics manufacturing business.

Process validation towards supporting biologics-product PAI.

Assisted in technology transfer efforts for novel virus-based vaccine manufacturing platform.

Support client-company in PAI preparedness and exception management (Impact Assessments).

Site PAT Champion to BioScience Division PAT Team. Winner of Baxter BioScience PAT award for 2009. DMAIC/Six Sigma certified Green Belt.Recognized facility Subject Matter Expert for fermentation, ultrafiltration, Statistical Process Control (SPC) and process validation operations. Transfer site expert assigned to facilitate the transfer of upstream manufacturing process from US (Maryland) to European (Austria) site from June, 2010 to December, 2010.Consultant assigned to provide technical assistance to a corporate partner for facilitation of rapid advancement of manufacturing capability for a mammalian cell culture-derived, viral-based vaccine.Facilitator of interdisciplinary teams employing Lean Manufacturing and DMAIC/Six Sigma quality engineering techniques supporting the manufacture of polysaccharide-based vaccines from bacterial fermentation processes in both trouble shooting and continuous-process improvement capacities.

Product manager for human blood plasma product intermediate (Fr II).Member of Change Control Review Board and Materials Review Board.Facilitator of interdisciplinary team employing Six Sigma quality engineering techniques supporting the manufacture of protein fractions from human blood plasma in both trouble shooting and continuous-process improvement capacities.Site technical manager for the transfer of licensed biologics processes between U.S. and European manufacturing facilities.

Development and scale-up of bacterial fermentation harvest, isolation and recovery processes for the production of research and industrial grade enzymes and nucleic acid products.Lead engineer in the construction of a clean/dry room facility for the production of room-temperature stable biologics.Introduced state-of-the-art normal and tangential-flow filtration concepts, systems and processes into existing manufacturing schemes.Lead scientist in the design, scale-up, procurement and installation (including IQ/OQ/PQ) of an ultrafiltration system for isolation of native, soluble proteins from permeablized cells.Lead scientist in the design, scale-up, procurement and installation (including IQ/OQ/PQ) of a microfiltration system for processing of several competent bacterial cell lines. Winner of Life Technologies' 1995 Annual Award of Excellence.

Mammalian cell culture of clinical grade monoclonal antibodies (25-250 L).Bacterial fermentation (10-250 L) for the production of clinical grade native and recombinant therapeutic proteins.Assay development for the identification, characterization and quantitation of proteins, including: spectrophotometric, PAGE, HPLC, colorimetric (Lowery, Biuret, BCA, etc.

Process development support for the manufacture of coagulation factors from human blood plasma.Instrumental in significant product yield enhancement initiatives.Worked closely with manufacturing in trouble shooting problem lots.Suspended leukocyte culture for the production of alpha and gamma interferons.