Going from Bench to Clinic
Translating newly discovered knowledge from the bench to the clinic can be a significant challenge. The wealth of new information pouring into research from genomics and other fields, and new advances in physics and materials science are continuously evolving into promising products being championed by universities and spin-off companies, as well as startup and virtual companies. These product candidates hold promise to improve the diagnosis as well as provide therapeutic options and enable better monitoring of medical conditions that, in turn, will improve patients’ lives.
To accomplish this cost effectively, scientific discoveries must be quickly and efficiently translated into clinical applications that will contribute to significant improvements in the quality of health. Such discoveries typically begin at “the bench” with basic research in which scientists study disease at a molecular or cellular level. However, the progression of the more promising advances to the clinical level, or the patient's “bedside” can be a long and arduous task.
Select GBI as your Preferred Partner
GBI can complement your efforts to bring promising biomedical advances from the early development stage through human clinical trials. As a full-service, integrated Contract Manufacturing Organization (CMO), GBI is one of the few CMOs capable of taking a biopharmaceutical or biologic from cDNA cell line engineering through to GMP cell banking, cell culture and purification development, GMP manufacturing and fill/finish of clinical lots --- i.e. from bench to clinic.
In addition to a focus on contract cGMP manufacturing of therapeutic and diagnostic antibodies, recombinant proteins and enzymes as well as cell-free protein vaccines expressed in mammalian cell lines, one of our core competencies is the conjugation of monoclonal antibodies and other proteins to small molecules, macromolecules, chemical polymers, and radionuclides for immunotherapy and immunodiagnostics. In the area of oncology in particular, we conjugate small molecule cytotoxic cancer drugs, plant protein toxins and radioisotope metal chelators to cancer-indicated antibodies and other proteins for high-potency immunotherapy.
With a 20-year history in biopharmaceuticals, GBI is one of the most experienced CMOs in the world. Our clients are from Eastern and Western Europe, North America and Asia, and include biotechnology startup firms, multinational biotechnology and pharmaceutical companies, research institutes and university laboratories, as well as government institutes and centers.
Blending Technical Expertise and Efficient Management of
GBI has the capability to manufacture milligram quantities of monoclonal antibodies, cell-free protein vaccines and recombinant proteins/enzymes for simple proof-of-concept and preclinical studies to hundreds of gram quantities for clinical trials.
We have performed contract process development and/or manufacturing work in nearly 370 projects involving numerous mammalian cell lines (CHO, NS/0, HEK 293, BHK, hybridomas, human melanoma cell lines and others) and have consequently developed considerable experience and expertise in the process development, GMP manufacturing and bioconjugation of biopharmaceuticals. For an overview of our capabilities and services, please click here.
For more information on partnering with GBI for your Translational Medical project, click here.