The increasing need for pharmaceuticals has led to the growing willingness to outsource drug development to Contract Drug Manufacturing Organizations (CDMOs).
In the past, pharmaceutical companies would only outsource their manufacturing services to contract drug manufacturing organizations owing to the plant capacity constraints. However, because of the dedicated & improved drug development and Research & Development facilities rendered by contract drug manufacturing organizations, the pharmaceutical industry is now slowly moving towards outsourcing a larger chunk of their processes, ideation, innovation & product development.
CDMOs are organizations within the pharmaceutical industry, which render drug development & manufacturing services. Pharmaceutical companies partner with CDMOs as a way to outsource drug development and drug manufacturing. Full-service contract drug manufacturing organizations can enroll in all aspects of drug development & manufacturing. They also work with clients who look to outsource certain components of their process, however, it all depends on what each client needs.
“Pharma/biotech companies have recognized the value that CRO/CDMOs can bring to their overall product development strategy and externalization has become a core element of all customer strategies. The Covid-19 pandemic has further established that outsourcing is vital and should be a core element of every company’s strategy.
From a ‘good-to-have’ situation, R&D outsourcing has become a ‘must-have’ strategy,” stated Mani Kantipudi, CEO, Aragen Life Sciences. Some of the services offered by contract drug manufacturing organizations include formulation, blending, analytical services, converting, coating, packaging, serialization, & shipment. When partnering with a full-service contract drug manufacturing organization, a pharmaceutical organization through clinical trials and commercial production, can begin with little more than a concept and be guided from pre-formulation and formulation development.
Integrated end-to-end services
The global pharmaceutical Contract Development & Manufacturing Organization market is anticipated to reach USD 236.61 billion by 2026. While the CMO/CDMO service industry is uniquely positioned to address some of the challenges that drug developers are facing during the pandemic period, it has impacted various aspects of the pharma & biopharma industry, right from drug development, clinical trials, supplies, manufacturing to supply chain logistics. “With rising demand for integrated end-to-end services, the CRO (contract research organization)/CDMO (contract development and manufacturing) industry will see increasing consolidation both at the global level as well as in India,” said Manni Kantipudi.
Partnering with CDMOs
Developing a new drug variation or a new drug is a multi-year as well as multi-million-dollar undertaking. Partnering with a Contract
Development Manufacturing Organization for the development and manufacturing of a new drug provides several benefits to pharmaceutical companies. Pharmaceutical organizations rely on Contract Development Manufacturing Organizations more and more, when it comes to the complexities of drug development and manufacturing.
Either it could be related to navigating the highly regulated drug development framework needed by the FDA or scaling manufacturing in order to meet the deadlines as well as demands, partnering with a CDMO is a great resource with numerous benefits for pharmaceutical organizations to focus their efforts as well as resources on initiatives that move their company forward.
Things to consider while choosing a CDMO partner
• Whether the CDMO partner has the technical expertise as well as experience to deliver on what you are looking to accomplish?
• Do they possess relevant experience in the drug delivery systems that you are targeting?
• Do the staffs possess the technical acumen for achieving what you are looking to achieve?
It is important look at how the Contract Development & Manufacturing Organization deals with partnerships and relationships
• Are they good listeners?
• Are they making you feel involved in the process?
• Are they the type of organization that will persevere alongside you, when things become stressful?
Lastly, look to their equipment & facilities
• What is their investment in laboratory space & equipment?
• What kind of machines are used for mixing, coating, & converting?
• Does the CDMO possess facilities to handle the manufacturing levels you seek?
Way forward
“The Indian CRO/CDMO industry has come a long way from its early days. It is no longer the low-cost chemistry-focused service provider; rather the sector has evolved to offer a wide range of integrated services that cater to the entire value chain of drug discovery, development, and manufacturing for both, small molecules and biologics.
I believe that Indian CRO/CDMOs today offer not just cost arbitrage but also operate at global standards in terms of science, quality, safety, business processes, technology, operating models and are making strategic investments in these areas,” affirms Kantipudi. Soon, Indian contract drug manufacturing organizations will look to provide end-to-end product development, scale-up, & regulatory approval solutions & manufacture compelling new products at a rapid rate.
Right from the phase of ideation to high volume production, all elements of new product Research & Development will be taken up by the contract drug manufacturing organizations that get into marketing alliances with strong branded generics organizations. contract drug manufacturing organizations will also have more diversity such as the capability to evaluate, scale-up, & manufacture the bacterial vaccines, mRNA vaccines, adenoviral vaccines, and specialized services related to these.
, CDSCO.jpg)
