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Efficiency, speed-to-market, and access to unique expertise are among the key benefits of partnering with a contract development and manufacturing organization (CDMO) offering integrated, end-to-end services.
Piramal Pharma Solutions provides customers in the pharmaceutical and biotech space with a fully integrated approach to drug discovery, development, manufacturing, packaging, and more. Piramal has a superior record of delivering successful product launches with the seamless transfer of technology, documentation, and materials across global sites. Regulatory know-how and deep experience across a spectrum of projects and categories further solidify the company's standing as an elite integrated CDMO.
In the initial days of integrated services, CDMOs were primarily geared toward early-stage development, helping clients obtain an investigational new drug (IND) application. Today, however, integrated CDMOs like Piramal Pharma Solutions assist companies across the entire development process, including late stage and commercial projects.
From discovery to intermediates, active pharmaceutical ingredients (APIs) and drug products, a CDMO requires expertise across multiple elements of the pharma process to deliver an integrated experience. Through comprehensive program management, Piramal oversees and executes all elements of this work on behalf of its clients and their patients. By taking ownership of the end-to-end integrated project, we gain in speed while also de-risking transfers between multiple CDMOs.
The Piramal organization is uniquely positioned to support its customers from project inception through commercial manufacturing, as well as providing specialized services like high potency APIs (HPAPIs) and bioconjugates (e.g. ADCs). Piramal has internal capabilities to assist companies along any aspect of a product development lifecycle. For example, if an innovator company has developed an API but lacks the ability to manufacture it internally, Piramal has the capabilities and know-how to spearhead an integrated program of scale up and commercial manufacturing across multiple sites.
To coordinate this complex web, first-class knowledge and customer care are essential. Clear communication and data and tech transfer between facilities in the CDMO are of the utmost importance. Our integrated program management provides unmatched oversight across all of its facilities to support a seamless experience for its partners.
There are numerous advantages to partnering with an integrated CDMO. However, over the company's nearly 40 years of experience, several primary factors continue driving customers to the exceptional services provided by Piramal.
Speed especially during early phase development is a huge asset for customers relying on a CDMO. A significant amount of integrated work comes from biotech or pharma companies with early phase candidates in their pipelines. Phase I, Phase II, and Phase III tend to be more integrated. Companies come to Piramal because they want custodianship and a trusted partner who can guide their product through the various phases of the product development.
Cost is another clear win when outsourcing to an integrated CDMO. Consider, for example, the steps required to source a high-value API. There are strong regulatory and technical benefits to working with GMP manufacturing sites in Europe or the U.S., while sourcing raw materials and intermediates in China or India may help reduce the cost of overall production. Piramal produces intermediates and starting materials at the company's facility in Ennore, India, and its Shanghai, China procurement center supports customers with raw material sourcing. Technology-rich sites in either India or the West then produce the finished API or drug product, giving the client an end-to-end integrated option for supply.
Senior and experienced leadership is yet another key component guiding our integrated offerings. With each of Piramal's projects, the client interface and the coordination of activities are handled by a veteran project manager who acts as the primary point of contact for the client. Global integrated program managers and project managers are customer advocates who shepherd each project through the production process.
The program manager oversees and coordinates complex and time-sensitive tasks on the client's behalf oftentimes across continents and differing regulatory environments. In an integrated project, there might be three specialist facilities working to deliver the project, with the program manager facilitating complex interactions with the client, our research and operations teams and other experts. These complex projects elevate the level of governance, reporting, and expertise needed for the CDMO. The team is often working in parallel, not in series, to deliver on optimal timelines.
Supply chain integrations for small-molecule chemistry are yet another offering clients require. Piramal is able to take responsibility for these initial API activities, and then backward integrate to produce the intermediates or KSMs internally, leading to reduced supply chain risks and assurance of supply for later stage and commercial products. Piramal is also able to help companies navigate this process from a regulatory standpoint, helping them determine where it makes sense to perform specific aspects of the project, depending on location, cost, and other considerations.
The core benefit of using integrated services is helping customers simplify their business through streamlined outsourced services. At the end of the day, if Piramal is making life easier for its clients, then the company is performing its stated functions well. With an expanding network of expertise across the various stages of the drug development and discovery pipeline, Piramal is well equipped to do just that.
Over the years, Piramal Pharma Solutions has expanded significantly and obtained a wealth of expertise through acquisition. As the organization has grown, every facility that has been acquired has become its own center of excellence within the network.
Looking ahead, integrated services will continue to be in high demand, offering essential services to the pharma and biotech industries. Industry wide, key acquisitions by major CDMOs are indicative of an industry shift toward integration. Likewise, Piramal is continually enhancing its network of first-class facilities throughout the world through capacity and capability expansions and acquisitions to improve the integrated experience for its clients.
The Piramal Pharma Solutions network of integrated service facilities currently includes:
• Aurora, Canada for the development and GMP manufacturing of NCEs
• Lexington, US for sterile fill/finish of liquid and lyophilized parenterals and injectables
• Riverview, US for the development and manufacturing of APIs and HPAPIs
• Sellersville, US for manufacturing and packaging of oral solid forms, liquids, creams, and ointments
• Grangemouth, UK for the development and manufacturing of Bioconjugates and ADCs
• Morpeth, UK for manufacturing, development and packaging of oral solid forms
• Ahmedabad, India (Development Services) for the development and manufacturing of GMP oral solid forms
• Ahmedabad, India (Discovery Solutions) for comprehensive discovery services including synthetic chemistry, in-vitro biology, in-vitro ADME, in-vivo biology, route scouting and scale-up
• Pithampur, India for clinical supply and commercial manufacturing of oral solid forms
• Digwal, India for late phase APIs and intermediates
• Ennore, India for GMP starting materials and intermediate
• Mahad, India for manufacturing of vitamins and premixes for human and animal nutrition
• Turbhe, India for peptide API development and manufacturing
• Hyderabad, India for process development and manufacturing of vaccines and biologics (through our associate company, Yapan Bio)
• Rabale, India for development of generic APIs
Working with a single CDMO throughout a project within a specific geographic region(s) is also trending. In some cases, this is driven by location, i.e. the proximity of the client to its patient populations.
Other considerations driving the move to geographic integration are the trend toward onshoring, as well as cost vs. quality requirements. With 15 sites around the globe, Piramal Pharma Solutions is well equipped to serve the specific needs of its clients and the people they're caring for.
With increased interest in integrated services coming from a variety of customers, including global pharma innovators, biotechs, and virtual pharma companies, the emphasis on this type of development program is growing. While every customer and program profile has a different need, there is a place for integrated services for each of them.
Piramal Pharma Solutions (PPS) is a Contract Development and Manufacturing Organization (CDMO) offering end-to-end development and manufacturing solutions across the drug life cycle. We serve our customers through a globally integrated network of facilities in North America, Europe, and Asia. This enables us to offer a comprehensive range of services including drug discovery solutions, process and pharmaceutical development services, clinical trial supplies, commercial supply of APIs, and finished dosage forms. We also offer specialized services such as the development and manufacture of highly potent APIs, antibody-drug conjugations, sterile fill/finish, peptide products and services, and potent solid oral drug products. PPS also offers development and manufacturing services for biologics including vaccines and gene therapies, made possible through Piramal Pharma Limited's associate company, Yapan Bio Private Limited.
