What are Contract Manufacturing Organizations?
Contract manufacturing organizations (CMOs), also called contract development and manufacturing organizations (CDMOs), provide drug development and drug manufacturing services in the pharmaceutical and biologics industry on a contract basis. Outsourcing manufacturing activities saves internal resources and enables pharmaceutical and biologic companies to prioritize additional initiatives and enhance process efficiencies.
With the fast-paced and evolving nature of the life sciences industry, CMOs must take the initiative to collaborate with pharmaceutical companies on sustainable business models to support major demands the pharmaceutical manufacturing industry is facing.
What is the Future of Contract Manufacturing Organizations?
Evolution of the pharmaceutical manufacturing industry is largely driven by the increasing demand of novel product classes (e.g. cell and gene therapy approaches). The shift away from blockbuster drugs to niche products requires improved manufacturing efficiency and quality to ensure products reach patients swiftly and safely. With the rise in personalised medicines, biologics, and generics, new factors must be considered to efficiently develop and deliver safe and effective therapies. Regulatory interests and environmental requirements are one of the many key factors to consider. In the early 2000s, the FDA issued its industry guidance “Pharmaceutical cGMPs for the 21st Century: A Risk-Based Approach”. This guidance encourages digitalization and the increased use of digital technologies, yet adoption and implementation are slow and little has changed. Quality by design, accurate first-time manufacturing, increased transparency into end-to-end manufacturing, and positive customer experiences are additional high-priority initiatives gaining attention. Demand will continue to grow for personalised medicines and modern-class therapeutics, and companies will be required to adapt to a market where high-value, multi-size batches are the norm. This will result in the emergence of new business models for productive collaboration between suppliers and their customers.
Improved end-to-end visibility and auditability, as well as increased development and manufacturing capabilities housed within individual organizations will become paramount to meet the need for speed to market and to drive growth by reacting quicker and more effectively to market dynamics.
Why Contract Manufacturing Organizations Need to Adapt
CMOs/CDMOs need to offer flexibility and wide-ranging capabilities to support key emerging technologies as pharma companies continue to look to consolidate supply chains rather than outsourcing to multiple partners. Offering a vast array of capabilities enables CMOs to tailor their process and services to customers, which can attract new lines of business and also retain clients working on new product classes. Wide-ranging capabilities enable CMOs to be agile and respond quickly to market demands as demonstrated by several CMOs pivoting to develop vaccines and various therapeutics in response to the COVID-19 pandemic.
In addition to maximizing capabilities, a positive user experience that replaces outdated traditional enterprise tools will aid in fostering effective partnerships and collaborations. Seamless and intuitive user experiences in consumer applications are now the norm as demonstrated on apps such as Facebook, Twitter, and LinkedIn, but this is lacking in the manufacturing industry. As the workforce is becoming increasingly digitally savvy, laborious and error-prone documentation and communication systems create frustrations, risk, and lost opportunities. To attract top talent and ideal customers, pharma manufacturers must equip their workforces with top-tier tools and technologies that provide the comprehensive digital data necessary to ensure the highest quality and manufacturing efficiency. Integrating user-centric digital technologies throughout the full life cycle of product development – from client acquisition to product packaging and delivery – has multiple benefits. It can build trust with clients and partners by building effective and transparent streams of communication, increase process efficiency and optimization by creating new points of measurements, and ensure product quality by having the ability to monitor the process throughout.
Biologics and other new drug classe have different manufacturing processes and regulatory guidelines that CMOs/CDMOs must comply with to ensure patients receive safe and effective treatments. As these processes and personalized medicines become the new norm, more and more manufacturers will need to adapt their capabilities and digital technologies to keep up with industry demands.
Three Examples of Innovative and Agile CMOs
Samsung Biologics provides end-to-end drug manufacturing and development services to pharmaceutical and biopharmaceutical companies to increase success to IND, minimize timelines to market, and ultimately get therapies to patients faster. As a one-stop service, Samsung Biologics’ capabilities range from cell line development to commercial manufacturing of drug substance and product, to biosafety and stability testing services while ensuring regulatory compliance at every stage of the process. The company offers advanced cGMP manufacturing facilities to meet the diverse scales and unique production needs of its clients. Samsung Biologics CDMO delivers comprehensive, customized, and flexible solutions to streamline the development and manufacturing of diverse biopharmaceutical products.
Recent activity and highlights:
● Launched a client-centric Virtual Exhibition Hall to digitally connect with current and prospective clients at BIO 2020.
● Partnered with GSK to secure additional manufacturing capacity for its innovative biopharmaceutical portfolio.
● Awarded the 2020 CMO Leadership Award for its excellence in Capabilities, Compatibility, Quality, Reliability, and Service categories across pharma, making this the seventh consecutive year the company has received this distinction.
Catalent is a global leader in providing integrated services, delivery technologies and manufacturing solutions to support life science companies develop and launch pharmaceuticals, biologics, and consumer health products.
They offer biologics services and have partnered with 20+ gene therapy companies for custom development and manufacturing of adeno-associated virus (AAV) vectors, next-generation vaccines, and oncolytic viruses. Harbors over 60 gene therapy programs across various stages of development and a total gene therapy footprint of 400,000+ square feet.
Recent activity and highlights:
● Appointed Charles Lickfold as Chief Information Officer to lead Catalent’s continuing digital transformation and automation strategy.
● Secures billion-dollar cell and gene therapy manufacturer acquisitions independently and in partnership with Thermo Fisher (e.g. CDMO Paragon Bioservices – $1.2B)
A biologics contract manufacturing organization with expertise in the development and preclinical/clinical manufacturing of biosimilars and biopharmaceuticals (monoclonal antibodies, recombinant proteins, vaccines, and bioconjugates). It offers a Single Source Solution scope of services to its client partners: cell line development, cell banking, cell culture and purification process development, scale-up, Tox manufacturing, and subsequent cGMP manufacturing with aseptic fill/finish for early-phase and late-phase clinical trials. In addition, Goodwin Biotechnology also has expertise in bioconjugation of monoclonal antibodies, recombinant proteins, small molecules, macromolecules, and polymers.
Recent activity and highlights:
● Launched a digitization initiative; licensed an electronic content and document management solution to enhance the efficiency and effectiveness of its quality systems and operations.
● Published “A look at current trends driving volume reductions in biopharmaceutical manufacturing and keys for successful outsourcing partnerships” (Read more here)
The status quo within the pharmaceutical manufacturing industry is unsustainable. CMOs continue to investigate new technologies, although industry adoption is notoriously slow. We will likely see wider industry uptake in the coming years as more organizations are pressured to innovate and transition to meet growing demands and new product requirements.