Oligonucleotide

EXPERIENCE IS ESSENTIALBecause only a handful of oligonucleotide (oligo) therapies have been approved, an industry standard specific to the design and engineering of oligo production facilities has yet to be established. Therefore, extensive experience in the field must be leveraged to ensure the efficient, effective and compliant design of facilities to produce oligo drugs.

CRB has been working in this product and process niche for many years and has been involved in dozens of oligo projects, including the design and engineering of development-, clinical- and commercial-scale (molar-scale) plants. CRB understands the chemistry involved in the synthesis of oligo drug substances and can communicate efficiently with clients about their processes. As a result, CRB can be a trusted adviser who can listen to and understand the needs of clients and rapidly provide tailored solutions to reduce product time to the clinic and the market.

UNRELENTING, INNOVATIVE EXPERTSCRB’s subject matter experts are a pioneering force guiding the industry in oligo manufacturing, plant design and chemical processes united in their commitment to deliver full-scale facilities that meet your manufacturing and regulatory needs. This multidisciplinary group applies direct operational experience to meet the specific needs of your product—and your business—with the goal of treating a wide range of conditions, including cancers, infectious diseases and genetic diseases.

Unlike other pharmaceutical platforms, such as peptides, small molecules or monoclonal antibodies, where time has borne out expertise in large-scale process design, the oligo field, which is still in its commercial infancy relative to these other modalities, does not have decades of commercial manufacturing experience upon which to draw. However, the oligo field is beginning to transition to this level of large-scale process experience as evidenced by the increase in drug approval and the significant increase in plant capacity. CRB is at the forefront of design and construction in support of these exciting new technologies.