Leveraging Infrastructure Investments and Innovation to Accelerate Biologics Development

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Paul Jorjorian, vice president/general manager, biologics, Thermo Fisher
Scientific

Jorjorian began by noting current trends in drug development, including more compounds being held for longer periods of time than in previous years by small and emerging pharmaceutical and biotechnology companies. He sees an increased complexity of molecules being brought to market, including bispecific antibodies and fusion proteins. Growth continues in both the cell and gene therapy segments and in orphan drug markets. From a business-dynamics perspective, such growth can create a mismatch between drugs in the pipeline and existing manufacturing capabilities. For that and other reasons, he noted that the industry needs to start thinking about capacity differently. Accelerating therapeutic timelines while reducing capital investment also is a current industry priority.

Jorjorian emphasized the strong growth of the biologics pipeline (~40% in 2019) and a large increase in the total number of therapeutics being manufactured. Positive trends also include a decrease in total volumetric requirements, primarily because molecules are more potent and titers are increasing. He noted a strong shift the distribution of manufacturing capabilities required to produce those therapeutics. A large percentage of drugs now can be manufactured at volumes under 5,000 L, and a large percentage of molecules can be manufactured at the 2,000-L scale — a clear reflection of the impact of single-use manufacturing and the capability to produce commercial volumes at that scale.

The rest of Jorjorian’s presentation focused on how Thermo Fisher Scientific’s pharmaceutical services are positioned to address challenges and opportunities presented by the current market. He emphasized his company’s strong focus on drug development and clinical trials logistics and its continued focus on commercial manufacturing. The need to bring in greater flexibility in business models to meet client needs at different stages of development also is a current priority. Through partnering and internal capabilities, the company can provide services in drug-substance and drug-product manufacturing, viral-vector manufacturing, and supply-chain support from clinical trial distribution to cold-chain storage, helping customers consolidate their supply chains to simplify their efforts in taking drugs through initial trials and to commercial manufacturing.

Thermo Fisher’s drug-substance and good manufacturing practice (GMP) network comprises sites operating at single-use scales in Missouri and New Jersey and in The Netherlands and Australia. A strategic partnership with CSL will introduce stainless-steel manufacturing at a site in Lengnau, Switzerland. Drug-product manufacturing occurs in North Carolina as well as in two sites in Italy. Jorjorian highlighted the company’s expertise in technology transfer, with more than 180 such activities executed since 2015, and also pointed to the company’s investments in long-term commercial manufacturing support for its customers.

Jorjorian focused on investments toward doubling available single-use capacity at a site in St. Louis, MO. Substantial investments in development capacity include plans to add 56,000 ft2 of development and office space next to the manufacturing facility to increase development and quality control (QC) capacity. Thermo has completed construction on a bioprocessing collaboration center, designed to bring together work on components, manufacturing, and analytics. A major focus of collaboration will be to augment data management and digitization tools for enhancing efficiencies in single-use manufacturing and within the broader biomanufacturing ecosystem. Another strategic investment at the St. Louis site involved a US$50 million expansion to add a “six pack” of bioreactors and an additional downstream suite. Improvements over earlier facility designs include platforms that allow access to top portions of single-use bioreactors without the need for ladders.

Jorjorian highlighted work with the Berkeley Lights Beacon system to shorten the time required for clone selection during cell-line development. He described how using multiattribute methods can provide insights into a number of molecular attributes with only a single method. And he highlighted ways in which his company is using technology to shorten overall process development workflows and enhance its “quick to clinic” platform.

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