Technical Expertise

BioPhia represents hundreds of years of combined experience in diverse fields across the healthcare industry.  Our industry experts have the experience you need to find the best solutions to drive your business to new levels and meet critical milestones in a timely, cost effective manner.

 

DRUG DISCOVERY 

 

  • Biomarker Identification
  • Complement Biochemistry
  • Immunology and Cell Biology
  • Cell Isolation and Cell Culture
  • Microscopy / Imaging
  • Phage Display and Molecular Biology
  • Flow Cytometry
  • Cloning
  • Bioanalytical methods development
  • High Throughput Screening Design

 

 

 

 

 

 

 

MEDICAL DEVICES

                                      

  • Biocompatibility (ISO, ICH, FDA, MDR)
  • Extractable / Leachable
  • Study Design and Protocol Development
  • Training
  • Combination Products

 

 

 

 

 

 

 

 

 

CHEMISTRY AND MANUFACTURING CONTROLS

  

  • Analytical method development and validation
  • Bioassay development
  • Chromatography
  • Impurity identification and isolation
  • Biochemical characterization
  • Protein isolation, modification and characterization
  • Statistical design and analysis
  • QbD design and implementation
  • Small molecule formulation development
  • Manufacturing design
  • Manufacturing Process scale-up
  • Manufacturing modifications
  • Viral/ pathogen safety
  • Technology transfer

NON – CLINICAL SAFETY

  

  • IV Administration – Acute Toxicity, Repeat Exposure, Neonatal Studies
  • Technical support for animal model blood collection and necropsies
  • Hands-on support and technical training of staff
  • IV,IP, IM, SQ, and oral test article administration