BIOTECHNOLOGY

These are a numerous, ever increasing categories of biotech products some of which are:

·        Monoclonal antibodies

·        Vaccines

·        Recombinant proteins (first, second and third generation)

·        Gene therapy

·        Bacteriophage therapy

·        Peptides

·        Antibody fragments

·        Antisense

·        Stem cells

·        siRNA

Each of the categories mentioned above has specific safety and development requirements. YBCA has experience in all of these categories and can help to guide you through the regulatory hurdles so achieve your goal. The development of any biotechnology product must be considered on a “case by case” basis which should be supported by a sound scientific rationale.

Biotechnology products are used therapeutically in a variety of diverse clinical indications such as cancer, HIV AIDS, rheumatoid arthritis, MS, osteoporosis and wound healing. We can help to prepare your development plan as well as help to design and implement the pharmacology studies, manufacture, preclinical safety and clinical studies. We have experience in all of these therapeutic areas and can help to interpret the numerous regulatory guidelines thus formulating the most efficient route into the clinic and also to either licensing out or to BLA for your product.