Dr. Jeri Ann Boose leads Lancaster Laboratories’ Biologics Programs
Leading biologics expert Jeri Ann Boose, Ph.D., has joined Lancaster Laboratories as director of Biopharmaceutical Services. In her new role, Dr. Boose will provide strategic, scientific and regulatory direction for the company’s rapidly expanding biopharmaceutical testing business, which includes extensive capabilities in the areas of biochemistry, cell and molecular biology and virology.
Dr. Boose has demonstrated expertise in the formulation of global regulatory product testing strategies and in the preparation of global regulatory filings at all stages of product development, as well as commercialization of new products for biopharmaceutical customers. Her specialties include knowledge of cGMP requirements, expectations and practices; assay and process validation; viral/TSE/microbial clearance validation; cell line characterization; raw materials testing; lot release testing; cleaning validation; analytical and stability testing.
“The combination of Dr. Boose’s renowned expertise in biologics, coupled with our comprehensive biopharmaceutical capabilities, clearly positions Lancaster Laboratories as a leading provider of services to support the development and commercialization of biologics products,” says Dr. Timothy S. Oostdyk, executive vice president & COO.
Dr. Boose brings 25 years of industry experience to the company’s growing Biopharmaceutical departments. Well-established as a leading authority in the areas of biosafety and more specifically virology, Dr. Boose has interfaced extensively with regulatory agencies throughout the world on both scientific and regulatory issues.
Key biologics teams Dr. Boose will lead include:
- Mycoplasma Services: To ensure customers’ global compliance for mycoplasma screening of cell lines and biological products , the Mycoplasma Team provides the full range of cGMP assays in compliance with United States Pharmacopeia Chapter monograph, European Pharmacopoeia Chapter 2.6.7, and FDA 1993 Points to Consider.
- Viral Safety and Clearance: For all stages throughout the development, manufacturing and release of biological products, this team offers comprehensive, fully cGMP-compliant viral safety and clearance services. All assays are validated to meet ICH Q2 requirements. With more than 20 years of viral experience, this technical staff provides the expertise and technical advice to ensure customers’ study design and execution is in compliance with FDA, ICH and EU Guidelines for Viral Safety Evaluation.
- Cell Bank Manufacturing: This team offers the single -source solution for all cell-line needs, featuring capabilities to manufacture, store and characterize a wide variety of mammalian cell banks, including master, working and research banks with expertise in cold-chain management. Its cGMP-compliant manufacturing facility includes multiple ISO 7 clean rooms and ISO 5 critical areas designed to meet current aseptic processing guidelines. Fully validated manufacturing procedures include process simulation studies to ensure the integrity of the manufacturing process.
- Molecular and cellular biology: With state-of-the-art molecular biology laboratories, including segregated and controlled suites, this team offers industry-leading experience in the development, optimization, qualification and validation of product specific cell-based and non-cell-based potency assays that meet regulatory guidelines for all phases of the development cycle.
- Biochemistry: The Biochem Team provides a comprehensive range of services to support biopharmaceutical development from routine testing to the complete characterization of proteins, monoclonal antibodies, nucleic acids and complex carbohydrates. Fully compliant with FDA, EMA and PMDA requirements, this team ensures total support to meet all drug development needs, including Method Development/Validation, Biosafety, Microbiology, Stability and Raw Materials testing.
Dr. Boose earned a Ph.D. from Georgetown University. She has published numerous papers in the field and has held positions in academics, government and industry.