To lead the expansion of ABC's biotech development services, we brought on board industry veteran, John C. Anders, Ph.D., and a core team of large molecule experts with decades of industry experience. Together with ABC's 300+ scientists company-wide, this team is poised to meet any biomolecule development challenge.

JOHN C. ANDERS, Ph.D., Director, Biotech Development Services

Dr. Anders brings more than 30 years of drug development experience using the latest technologies required for analysis of biopharmaceutical products. Having worked in the CRO CGMP environment for more than 18 years, he has assisted scores of biopharmaceutical clients with their large molecule products. In addition to his experience with classical biopharmaceuticals, Dr. Anders was instrumental in developing a new class of molecular genomic expression medical diagnostics to meet regulatory requirements; these diagnostics will be critical to the industry’s drive to realize the potential of personalized medicine.

• Key Qualifications:
  • 30 years’ experience and academic training in molecular biology and protein chemistry techniques.
  • 20 years’ experience in development and analytical testing of large molecule drugs—including proteins, peptides, antibodies and oligonucleotides—under GLP and CGMP requirements.
  • 10 years’ experience in development of small molecule drugs for both preclinical ADME applications as well as CMC applications.
  • Experience assisting with numerous IND to NDA regulatory submissions for new drug entities.
  • Extensive experience in all common electrophoretic and chromatographic methods for macromolecular analysis
  • Expertise in numerous MS techniques in the analysis of macromolecules ranging from LC/ES/MS/MS to LC/ES/TOF/MS techniques
  • 14 years of prior experience building and leading a state-of-the-art CGMP biopharmaceutical analytical CRO lab
  • Successfully submitted an Investigational Device (IDE) submission to include a clinical validation protocol to the FDA for a lung cancer risk assessment test for current and former smokers over the age of 50. The clinical validation is scheduled to begin Jan 2010.

ROBERT MARLOWE, Senior Scientist, Bioassays

Robert has a broad background in many analytical techniques routinely employed in QC lot release and stability testing of biopharmaceuticals, with expertise in biological potency testing. The addition of Rob’s extensive bioassay experience to the ABC arsenal of analytical tools rounds out our team, providing expertise in cell-based bioassay, biomarker analysis and immunological testing to include ELISA to provide crucial biological potency and safety testing to the Biotech Services Group.

• Key Qualifications:
  • Routine and specialty analytical assays including cell culture bioassays, ELISA, LAL endotoxin analysis, dye-binding protein assays (BCA, Bradford, Lowry), residual host-cell DNA analysis, GC, and CE.
  • Lot Release and Stability analysis of potential therapeutics using cell based assays with various endpoints including radio-labeled endpoints.
  • Quantification of multi-component formulations by LC/MS/MS.
  • Analysis of proteins and peptides by amino acid analysis and N-terminal sequencing.
  • Method evaluation, transfer, development, and validation; subsequent generation of test reports and test procedures.
  • Acquisition and installation, qualification, validation, troubleshooting and maintenance of essential technical equipment.
  • Broad knowledge of the full range of molecular biology techniques.
  • 15 years’ experience in CGMP CRO environment.

BRIAN G. TALBOT, Senior Scientist, Chromatography

Brian has a long track record for successfully completing the most difficult methods when others have failed. He is proficient at a number of analytical techniques, and is exceptionally skilled at developing HPLC methods using reverse phase, normal phase, and ion exchange chromatography. In addition, Brian is an expert in capillary electrophoresis (CE). He has developed a variety of methods including capillary zone, ion focus, and micellar electrophoresis. The breadth of his skills and experience provides additional flexibility needed to meet the numerous analytical challenges encountered in the modern biopharmaceutical analytical laboratory.

• Key Qualifications:
  • Analytical identification and characterization of peptide and protein therapeutics/biologics by capillary electrophoresis, HPLC, electrophoresis, spectroscopy and fluorescence spectroscopy to support peptide and protein drug development activities from initial product formulation though resolving product stability issues.
  • Excellent analytical assay problem-solving skills to support method development activities and method validation.
  • QC release testing of recombinant proteins for pharmaceutical applications.
  • Experience in CGMP/ISO regulated manufacturing environments.
  • Extensive experience in a regulatory laboratory environment for both GLP and CGMP compliance.

ROWEL B. TOBIAS, Ph.D., Senior Scientist, Chromatography

Dr. Tobias’ expertise in HPLC, mass spectrometry and peptide mapping of glycoproteins provides critical information on post-translational modifications (PTM), disulfide bond analysis, glycan and glycopeptide profiling to support process and clinical drug development. His peptide mapping and intact analysis expertise provide for protein identity and purity, primary structure and MW confirmation, structural characterization and comparability of “well-characterized biologics” to comply with CMC requirements and ICH Q6B guidelines.

• Key Qualifications:
  • Analytical characterization of protein therapeutics/biologics by HPLC, mass spectrometry, electrophoresis and fluorescence spectroscopy to support CMC (IND) and drug development activities.
  • Physicochemical analysis of recombinant proteins and problem-solving skills in analytical assays to support CMO activities.
  • Analytical method development, qualification and transfer particularly in HPLC, ELISA and bioassay.
  • Analysis of sugars and carbohydrates by HPLC, GC-MS, enzyme and chemical assays.
  • QC release testing of recombinant proteins for pharmaceutical applications, immunoreagents (proteins and antibodies) and for FDA-cleared immunodiagnostic tests.
  • Experience in CGMP/ISO regulated manufacturing environments.
  • Knowledge of regulatory submissions, as well as GLP and CGMP compliance.

ROGER D. SUMMERS, Senior Scientist, Protein Chemistry

With over 15 years of experience in analytical protein assays, Roger Summers provides critical expertise to ABC. He has extensive knowledge in protein purification (specializing in monoclonal antibodies) and is highly skilled in the art of separations technology. His analytical experience includes method development for protein and small molecule characterization assays that have been specifically used in stability and release profiles for regulatory approval. This knowledge has contributed to successful full-scale process development procedures, and the release of small molecule and protein therapeutics in commercialization.

• Key Qualifications:
  • Experience using UPLC, HPLC in SEC, Ion exchange, RP and affinity chromatography on a variety of small molecules and proteins in manufacturing and from prokaryotic and eukaryotic sources. Other techniques include SDS-PAGE, immunoassays, total protein assays, N-terminal sequencing, AAA and 2D gel analysis.
  • Experience in purification and characterization of biologics from genetically modified organisms (recombinant sources) specializing in monoclonal antibodies.
  • Analytical support for manufacturing to ensure process suitability.
  • Proficient in the use of Empower, Turbochrom, Chromquest and Biocad software with PE, HP, TSP, Shimatazu, Waters and Visions HPLC systems, as well as AAA with Beckman 32Karet.
  • Proficient in CGMP-GLP criteria.
  • Extensive experience with heterogeneous protein expression, purification and characterization techniques specifically related to biopharmaceuticals.