Process Design Consulting &
GMP Facility Requirements
GXP Consultants will provide the highest quality service in Biotechnology, Pharmaceutical, Medical Device and Diagnostics Facility Layout and Construction to assure compliance with US FDA and International Regulations. Facility compliance and construction are addressed from a process, regulatory and safety perspective.
GMP Process Requirements
GXP Consultants provides you with the highest quality service in process equipment design and construction in addition to process, methods and cleaning development and validation for Biotechnology, Pharmaceutical and Medical Device and Diagnostic Industry.
GXP Consultants is your local provider of high quality consultants to address your process and facility construction needs. A selected list of services include but are not limited to:
- CELL AND MICROBIAL CULTURE
- BLOOD FRACTIONATION
- PARENTERAL INJECTABLE PHARMACEUTICALS
- SOLID DOSAGE PHARMACEUTICALS
- FACILITY DESIGN, CONSTRUCTION AND COMPLIANCE
- Cell and Microbial Culture Process Development and Scale-up
- Bioreactor Design and Selection
- Down Stream Process Development for Cell and Microbial Culture Products
- Plasma Fractionation by Cohn and Modified Ethanol Precipitation methods.
- Process Analysis and Trouble Shooting
- Protein Purification by Precipitation, Batch and Ion-Exchange Chromatography, Affinity chromatography and Tangential Flow Filtration.
- Viral Inactivation for Proteins and Biologically Active Solutions by Heat Treatment, Solvent Treatment, Nanofiltration etc.
- Design of Experiments (DOE) for definition of Critical Process Parameters and Range
- Aseptic Process Design and Validation for Parenteral Solutions
- Solid Dosage Process Design, Equipment Selection and Validation
- Analytical Methods Development and Validation
- Process and Cleaning Validation, Contamination Control
- Facility Construction and Commissioning
- Facility Design and Modeling using 2D and 3D CAD Modeling
- Facility Operations Flow and Compliance and Utility Validation