ABSTRACT
Biotechnology has contributed significantly to a robust biopharmaceutical industry and health care globally. Like chemically synthesized pharmaceuticals, biologics are subject to regulatory and policy approvals prior to marketing to the public. The entire process of identifying the gene of interest, the host biologic system, the personnel, equipment, the uncertainty of the regulatory climate, and others translates into high costs associated with biologic medicine. Clinical research as a matter of categorical and regulatory imperative must align with international and local ethical considerations from preclinical, clinical, and post-approval clinical testing and research due to some precedent about the mistreatment of research subjects. The biologic manufacturing process is an intellectual property and trade secret intrinsically, and biotechnology corporations and regulatory bodies have keen interest and fiduciary obligations to protect it. Biotechnology-based recombinant biopharmaceuticals generally are under the aegis of almost the same regulatory pathways and phases like new chemical entities (NCEs) counterparts but obviously with some ancillary changes.
