The biopharmaceutical industry has seen massive growth over the past few decades driven by advancements in technologies like genetic engineering and cellular/molecular biology. As a result of this growth, biologic drugs which include vaccines, monoclonal antibodies (mAbs), recombinant proteins, gene and cell therapies have emerged as important treatment options for various diseases. The development of these complex biologics however requires specialized expertise, technologies and infrastructure which is driving more companies to rely on outsourcing to Contract Manufacturing Organizations (CMOs) and Contract Research Organizations (CROs). In this article, we explore the growing role of CMOs and CROs in the biopharma industry.
Role of CMOs
As biologics development becomes more complex, outsourcing drug substance and drug product manufacturing activities to specialist CMOs has become almost essential for innovator biopharma companies. According to a report by IndustryARC, the global biologics contract manufacturing market size is expected to reach over $70 billion by 2026 growing at a CAGR of 7.4% during 2021-2026. Some of the key services offered by CMOs in this space include:
Clinical Manufacturing
For biologics entering early clinical trials, CMOs with expertise in working with cell lines and developing manufacturing processes are relied upon for clinical manufacturing. They help produce quantities ranging from grams to kilograms as required during Phase I-III trials. Specialized capabilities in mammalian cell culture operations, purification techniques, analytics and quality control are important at this stage.
Commercial Manufacturing
Once a drug receives approval, CMOs play a vital role in setting up commercial scale biomanufacturing facilities and helping produce large, regulated batches of several hundreds of kilograms per year. Their experience in technology transfers, scale-up, validation and meeting global regulatory standards is leveraged. Many CMOs now have multi-product commercial facilities dedicated to biologics.
Analytical Services
Developing robust analytical methods and carrying out extensive characterization, stability and comparability testing of biologics is another core area where CMOs help. Their expertise in techniques like chromatography, mass spectrometry and immunogenicity assays supports product development and licensure.
Fill/Finish Activities
The filling, packaging and labelling of biologic vials/pre-filled syringes into their final containers under aseptic conditions also requires specialized equipment and expertise available with CMOs on a global scale.
Role of CROs
While CMOs handle manufacturing, CROs play a pivotal role in the research and development of biologic molecules like antibodies, proteins and gene therapies. They provide a wide array of drug development services which can be broadly categorized as:
Discovery & Preclinical Research
CROs employ multi-disciplinary teams of scientists, researchers and project managers to support early drug discovery programs. Their aim is to help identify, validate and optimize drug targets and candidates. Preclinical assessment services involve assays, toxicology and PK/PD studies.
Clinical Trial Management & Biostatistics
Managing global clinical trials involving thousands of participants across hundreds of sites requires significant expertise. CROs coordinate all trial operations, monitor sites for compliance, collect and analyse data and provide biostatistical support. They also conduct bioanalytical testing for clinical samples.
Regulatory Affairs & Compliance
Having deep regulatory knowledge of agencies like FDA and EMA helps CROs successfully navigate the drug approval process. They draft multiple regulatory documents, ensure adherence to guidelines and act as liaisons between sponsors and regulators.
Medical Affairs & Safety
Post marketing commitments like pharmacovigilance, risk and safety management, medical information requests, publication strategy and outcomes research are also assisted by CROs. Their therapeutic expertise enhances medical affairs support.
Outsourcing has thus become integral to the Global Biopharmaceutical CMO And CRO given the complex, capital intensive and long product development cycles involved with biologics. By leveraging the specialized expertise of dedicated CMOs and CROs across various stages, companies can focus on their core competencies of drug innovation while gaining access to globally scalable infrastructure and capabilities. This has certainly aided progress in biologic drug development and delivery over the past decades and will continue enabling more life-saving therapies.
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