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Rita Peters is editorial director of Pharmaceutical Technology, Pharmaceutical Technology Europe, and BioPharm International.
The need for manufacturing speed inspires contract manufacturers to explore advanced processing technologies.
Emerging therapies are testing the capabilities of biologic drug manufacturing companies, as well as contract development and manufacturing organizations (CDMOs) and contract manufacturing organizations (CMOs). As a result, these manufacturers are employing process optimization and scalable advanced technologies to produce more product in less floor space.
“To respond to market needs for capacity, speed to manufacturing, modular platforms, and workforce training are at the forefront of any business strategy,” says Michelle Stafford, global marketing leader, BioProcess Solutions, GE Healthcare Life Sciences. “Speed to manufacturing can include in-sourcing/outsourcing analysis, which will take into account the long-term business plan, [intellectual property] IP protection, capital expenditures, time to market, and the technical capabilities of manufacturing or CDMO personnel. The result of this analysis will determine if capacity is outsourced to a CDMO or organic expansion and training is warranted.”
“For mammalian manufacturing, there have been significant expansions in CMO/CDMO capacity over the past year with many companies announcing new facilities,” explains Charles Christy, head of commercial solutions, Ibex Dedicate, Lonza Pharma & Biotech. “Single-use technology is facilitating rapid addition of capacity, and process intensification is also playing a role in optimizing existing assets.”
CDMOs have stepped up investments in cell therapy and gene therapy capabilities to secure a share of this market and to foster small biotechs in advancing prospective therapies. Most notably, in the first half of 2019, Thermo Fisher Scientific acquired Brammer Bio for $1.7 billion and Catalent purchased Paragon Bioservices for $1.2 billion, giving the CDMO giants capacity in viral-vector manufacturing.
While this consolidation means there are fewer competitors in the market, industry experts see benefits including standardization of methods, simplified vendor management, and use of advanced technologies.
“CMOs not only provide manufacturing capacity on the traditional side, but also build the capacity for novel modalities,” says Andrew Bulpin, head of process solutions, MilliporeSigma. “This enables small and virtual companies to stay independent longer.”
“Consolidation of the contract services industry should translate into better standardization of methods and give more flexibility in scheduling capacity,” says Phil Vanek, general manager, cell and gene therapy strategy, GE Healthcare Life Sciences. “These improvements should be realized in the coming years; however, integration efforts may cause some growing pains in the near-term. As there is currently a high demand for talent in the industry, this consolidation will also likely foster better sharing of expertise and help bring the industry up to speed (technically) much more quickly.”
“As more and more services companies take on commercial manufacturing at scale, there should be an easing of capacity demand for earlier-stage clinical activities, which is taking up much of the capacity today,” Vanek says. “The other major change will be increasing integration into the clinical workflow, with scheduling and logistics management becoming a bigger share of the manufacturing burden.”
Working with CDMOs or CMOs that can offer end-to-end solutions can be valuable for smaller biotech companies who don’t have the resources to manufacture in house or manage complex supply chains, says Christy. “For any company, large or small, dealing with one quality system, one project manager, etc., simplifies the process. For larger companies with a range of modalities/projects, working with one CDMO can provide more leverage and they can expand across technologies quickly,” he says. “It also takes time to develop trusted working relationships with outsourcing partners. Companies working with partners that provide solutions across the modalities and value chain mean that they can hit the ground running on new projects with the same CDMO, saving time, internal resources, and leveraging synergies.”
In addition, acquisitions have allowed contract manufacturers to invest significantly in capacity, says René Gantier, director, process R&D, Pall Biotech. “And, the rise of contract service organization acquisitions by technology suppliers is accelerating the development of fit-to-purpose bioprocess technologies and the implementation of these advanced technologies into new bioprocesses.”
MilliporeSigma is a CDMO, as well as a developer and manufacturer of process technologies, with more than 30 years of drug manufacturing expertise and more than 250 biologics to date delivered through its three global bio development centers, says Bulpin. Looking ahead, he says, “The industry will see added capacity, development of quality and regulatory compliance standards, and the development of templates and processes for novel modalities.”
Christy anticipates further expansion along the value chain with more focus on specialized solutions for increasingly complex medicines. “For example, some companies may choose to outsource development or manufacturing that requires very specific know-how or technology, such as bioconjugation/antibody-drug conjugates or live biotherapeutic products that target the microbiome,” he says. “Inevitably, the creation of fewer large CMO/CDMOs leaves space for smaller, niche companies to develop very specific offers.”
Partnering and in-licensing are also important in applying new technologies to manufacturing, Christy continues, citing a transposon-based technology Lonza is developing to improve stable expression of increasingly complex proteins, which are becoming important in the development pipeline.
Supplement: Partnering for Bio/Pharma Success
When referring to this article, please cite it as R. Peters, “More Capacity and Technology Translate to More Options," Pharmaceutical Technology Partnering for Bio/Pharma Success Supplement (February 2020).