Biologics drugs encompass a wide range of therapies including monoclonal antibodies, vaccines, protein and peptide therapeutics, cell therapies, viral vector gene therapies, nucleic acid (DNA and RNA) based therapies etc. These therapies are typically administered as injections or infusions and in specific cases via inhalation. Historically, new drugs have been primarily small molecules but increasingly new drug modalities such as cell and gene therapies and mRNA-based vaccines have increased from 11 to 21 percent of the drug development pipeline, which is the fastest growth seen in the sector1. Along with pipeline growth, the approval of biologics therapies has increased. In 2021, CDER (Center for Drug Evaluation and Research) approved 50 new drugs of which 34% were monoclonal antibodies and biologics2.
The growing pipeline and drug approvals requires increased high-quality manufacturing capabilities. It is important to note that manufacturing biologics for clinical trial and commercial use is challenging compared to chemically defined small molecule drugs. The manufacturing process requires high quality input material such as producer cell lines, sterility across the process and multiple testing points3 and scaling up a biologics manufacturing process can result in quality issues and insufficient supply to meet demand3. Due to the complexity of scale up manufacturing, drug developers are increasingly turning towards CDMOs or contract development and manufacturing organizations instead of building manufacturing facilities in-house.
CDMOs typically offer end-to-end services from drug development through manufacturing and filling and packaging the drug products. Due to the rapid growth in the biologics pipeline, the growth rate for biologics CDMO is expected to almost double from $9.9B in 2020 to $18B in 20264. However, it is important to select the right CDMO and there are some key considerations for this selection process. It is critical to ensure that the CDMO has the right mix of personnel talent to support manufacturing of the drug modality of interest, and build a product development process that is scalable. Good CDMOs have a mix of top-tier scientists, technicians, process engineers and quality control personnel as well as other core functions. Another critical consideration is how much importance the CDMO places on quality assurance and compliance with regulatory requirements. Most CDMOs have product development and manufacturing capacity and processes in place but well reputed and experienced CDMOs will understand the critical importance of robust quality control systems that monitor and document every step in the manufacturing process. Along with quality control, CDMOs that have expertise in global regulatory requirements especially if the drug is going to be launched in multiple markets5. From a practical point of view, it is important for a CDMO to be engaged with the drug developer and communicate frequently especially if there are supply chain issues, manufacturing delays or process development challenges.
Due to the various considerations, biopharma companies often prefer to partner with a single CDMO partner who fits their needs. The partnership between a drug developer and CDMO is typically a long engagement so finding the right partner who is financially stable with an open transparent culture is critical for success. A recent survey of 50 drug developers highlighted the top 3 reasons to outsource to a biologics CDMO as risk mitigation, speed and access to a portfolio of skills6. Mitigating process development and manufacturing risks typically require the CDMO to have robust infrastructure, scientific expertise, robust quality control systems and regulatory compliance expertise. Available manufacturing capacity and personnel experience are key contributors to achieving program timelines.
In summary, selecting a CDMO requires going beyond manufacturing capacity and processes to ensure that a biologics drug manufacturing program is successful and achieves the timelines, scale and quality required for clinical trials and commercial use.
References:
1https://www.contractpharma.com/issues/2023-01-02/view_columns/cdmo-trends-outlook
3https://www.statnews.com/2020/02/13/biologics-require-manufacturing-excellence-at-every-stage
4https://www.mantellassociates.com/blog/2021/08/the-rise-in-biologics-cdmo-market-value
6https://www.labiotech.eu/partner/outsource-early-clinical-pipeline-cdmo/
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