cGMP Biopharmaceutical Services

EAG brings the convenience and efficiency that comes with having a full-service analytical partner to biopharmaceutical development.  We approach each program with a thorough understanding of your commercial goals and the unique characteristics of your molecule. Based on this knowledge we work with you to customize a development plan that balances regulatory expectations with expediency and cost.

Our laboratories are well-equipped with ample cell-culturing capacity and the full spectrum of instruments typically employed in biopharmaceutical analyses. And, our team of veteran biopharmaceutical scientists has earned a reputation for approaching technical challenges with flexibility and resolve and bring their expertise and experience to bear in a holistic approach to your project. With >30% of our biopharmaceutical scientists holding a doctorate degree, we bring insight to even the most difficult demanding problems.

EAG has a wealth of experience with a wide variety of biopharmaceutical products:

  • Monoclonal Antibodies (mAbs)
  • Antibody Drug Conjugates (ADCs)
  • Biosimilars
  • Fusion Proteins
  • Pegylated protein
  • Oligonucleotides
  • Peptides
  • Vaccines

Method feasibility, development, validation and transfer

  • Cell bioassay method development, optimization and validation (cytotoxicity, reporter and proliferation)
  • Dose formulation/compatibility studies
  • IND and clinical bioanalytical support

Comprehensive CMC support for regulatory submissions

Demonstrating a deep understanding of biopharmaceutical stability is one of the most critical aspects of a successful Chemistry, Manufacturing and Control (CMC) submission. The complexity of biologically derived molecules provides literally thousands of possible sites for degradation including deamidation, truncation, oxidation, reduction and aggregation. EAG has extensive experience developing, validating and implementing the wide variety of assays required in support of cGMP release testing and stability studies.

  • Cell Bioassay
  • ELISA/ECL
  • UPLC/MS
  • UPLC
  • icIEF
  • CE-SDS
  • SEC-MALS

In addition to the protein itself, EAG has developed and validated methods for:

  • Cell Culture components (IPTG, antibiotics, Protein A…)
  • Excipients (surfactants, sugars, amino acids…)
  • Particulates
  • Host Cell Protein and DNA
  • Residual solvents
  • Residual heavy metals

 

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