Contract manufacturing of pharmaceuticals is growing rapidly and has recently seen an uptick in merger and acquisition activity, such as Thermo Fisher’s bid to acquire Patheon. Despite the consolidation, outsourced pharmaceutical manufacturing remains a fragmented market, as outlined in a recent report and summary. Discovering and qualifying outsourced service providers is already challenging, and the persistent fragmentation compounds the challenges.
Science Exchange has a unique vantage point for evaluating contract manufacturing services based on our diverse client base and the associated customer experience scorecard data we gather. In this article, we share our insights around navigating the complex contract manufacturing sector.
Demand for contract manufacturing services
The high demand for external manufacturing capacity and expertise is one driving force behind the proliferation of CMOs and CDMOs. According to a 2016 survey, biopharma organizations cite the need to improve quality as the primary reason for using contract manufacturing organizations (CMOs) and contract development and manufacturing organizations (CDMOs). Additional goals for outsourcing include reducing time to market, controlling costs, achieving supply chain diversity, leveraging regulatory expertise, and accessing specialized technologies, including those required for complex biologics manufacturing processes.
“The high demand for external manufacturing capacity and expertise is one driving force behind the proliferation of CMOs and CDMOs”
Competition between CMOs: Innovative manufacturing services
Competition in the marketplace is driving CMOs to develop innovative manufacturing technologies to capture new service categories—choosing a cutting-edge CMO partner can give a biopharma company advantages over its competitors.
Many CMOs and CDMOs have adopted process improvements to provide their clients with faster cycle times and more informed decision-making. These improvements include cloud-based computing, real-time risk-monitoring tools, and integrated quality-by-design during process development. Such process improvements are especially important given the ability of multiple CMOs to manufacture the same API. Nearly 90 percent of the volume of drugs sold are generic small molecule therapeutics, requiring high production capacity that may be provided by any number of CMOs.
Other CMOs differentiate themselves through specialized expertise—for example, they may be leaders in developing novel formulations, such as nanoparticles or lipid-based delivery systems. Some CMOs offer specialized regulatory certifications, such as CLIA/ CAP, GLP, and GCP. Although cGMP compliance is not absolutely required for all CMOs, most reputable CMOs are cGMP certified.
Contract manufacturing of biologics and complex therapeutics: a growth opportunity
It has been challenging to outsource the manufacture of biologics, such as vaccines, therapeutic monoclonal antibodies, and cell therapies, and non-biological complex drugs. These fast-growing segments are faced with regulatory hurdles, a need for specialized drug delivery devices, and inherent risks involved in method transfer and ensuring consistent supply.
Despite the challenges of method transfer, technological improvements are facilitating partnerships between biopharma companies and CMOs in biologics pipelines. Emerging categories of therapeutics, such as cell therapies and antibody-drug conjugates, as well as novel formulations, such as nanoparticles, have benefited from specialized manufacturers. Even though some of these specialty drug products may require bespoke manufacturing processes, CMOs stay agile through integrated quality-by-design during process development and take advantage of connected single-use technologies for streamlined yet flexible bioprocessing.
Barriers facing discovery and qualification of manufacturing service providers
The demand for contract manufacturing, combined with the growth opportunities around innovation and biologics, have resulted in a marketplace with thousands of active CMOs and CDMOs. It can be time-consuming and difficult to identify qualified service providers with the right certifications to meet regulatory compliance requirements. Though many service providers are staffed by innovative, highly qualified scientists with experience in the biopharma industry, many service providers lack such expertise.
Because there are no clear third-party qualification processes or objective benchmarks for quality and because biopharma companies lack the time to perform regulatory compliance audits of all the service providers in this fragmented sector, over 68 percent of biopharma companies use a preferred provider strategy for outsourced manufacturing. Relying on preferred providers may decrease the agility of companies to take advantage of emerging technologies.
For contract manufacturing to add maximum value to an organization, responsible teams should consider adhering to a defined sourcing strategy.
Checklist for a successful contract manufacturing partnership
To maximize the advantages offered by a successful CMO partnership, the procurement and external resource management teams of a biopharma company must ensure that their sourcing strategy includes:
• Keeping abreast of emerging technologies and service providers;
• Stringently qualifying service providers based on turnaround time, product quality, cost, and regulatory compliance;
• Identifying service gaps and assessing value of existing preferred providers;
• Streamlining the contracting process to enable rapid onboarding of innovative service providers;
• Establishing contracts that protect intellectual property and confidentiality, to maintain competitive advantage and minimize risk;
• Managing project milestones to ensure that projects are completed on time and as planned;
• Keeping meticulous records so that methods can be transferred in house or to other service providers as needed.
Science Exchange streamlines management of strategic manufacturing partnerships
Science Exchange, the largest marketplace for outsourced scientific services, enables biopharma companies to rapidly find and order cutting-edge technologies and services from a proprietary network of 2500+ qualified service providers, including many providers of contract manufacturing services.
Science Exchange’s Provider Management Team continually seeks to build its network by adding high-quality, innovative service providers with cutting-edge expertise in emerging manufacturing technologies.
Science Exchange’s dedicated staff scientists on our sourcing team help biopharma manufacturing teams find the best service provider for each scope of work, obtain multiple competitive quotes, and provide end-to-end project management. By using Science Exchange, manufacturing teams save hours or days per project that they would otherwise spend identifying providers, obtaining quotes, and managing projects.
Science Exchange mitigates inherent risks of outsourced manufacturing; all service providers on the platform are pre-qualified through a stringent vetting process and provide information on past performance, using an ISO 9001 Quality Systems-certified process.
Manufacturing scientists at top biopharma companies are already using Science Exchange to access hundreds of qualified specialty providers. The platform is enabling these scientists to order services from known and new manufacturing service providers, such as ImQuest, Almac Sciences, Recipharm, ChemPartner, Synovel Laboratory, Bioneer A/S, Solvias AG, WuXiAppTec, Lonza, and Piramal.