Shenandoah's Pharmaceutical Outsourcing Fact Sheet

Manufacturing and Services

Company Summary
 - Woman-owned business (WBENC certified)
 -  Small, fast growing and responsive company
 -  All manufacturing occurs in Warwick, PA northeast of Philadelphia
 -  10 years in business

Manufacturing  Capabilities 
  - 
5,000 square feet of lab space

  E.coli produced purified proteins
      - DNA cloning for bacterial expression
      - Bacterial inclusion body protein refolding
      - 5 Liter, 20 Liter, 80 Liter bacterial fermentation capabilities for mg to gm quantities
      - Protein vialing and lyophilization
  Mammalian produced purified proteins
      - DNA cloning for mammalian expression

      - Creation of stable cell systems (HEK 293, COS and CHO cells) 

 QA Testing Capabilities
   - Sequence verification - mass spectrometry
   - Quantitation and Purity - SDS PAGE, spectrometry, HPLC
   - Bioactivity - cell based growth assays and chemotaxis studies
   - Endotoxin - kinetic LAL down to 0.05 EUs/ug of protein
 
Documentation Processes
  - Batch record documentation, equipment logs, training logs, electronic notebooks
  - Certificate of Analysis, Certificate of Origin and MSDS documentation

Experience
   - Repeat bulk (gram to kilogram quantities) production for small, medium and large pharmaceutical companies
   - Fast turn around time of 6 weeks for large fermentation and purification projects
   - Collaborate with other small biotech companies for antibody and ELISA kit manufacturing

 

 Contact:  [email protected] or 877-613-6020