Issue link: https://www.e-digitaleditions.com/i/1532595
8 Pharmaceutical Technology ® | BioPharm International ® Bio/Pharma Outsourcing Innovation February 2025 PharmTech.com NE X T-GENERATION THERAPEUTICS form (such as what Trenchant BioSystems has done) that can dramatically reduce costs and timelines. Addressing unmet needs As next-generation biotherapies grow more complex, drug developers are increasingly seeking specialized services in areas such as advanced analytics, process development, and regulatory compliance, specifies Paule. She explains that there is a growing need for expert support in CGT process development, manu- facturing, clinical trial supply logistics, and sourcing good manufacturing practice-compliant raw mate- rials. Meanwhile, demand for artificial intelligence (AI)-driven process optimization and custom drug delivery systems is also on the rise as developers seek to ensure stability and efficacy. "Also, developers are realizing the value of deep expertise in specific areas and the benefits of using well-established platforms instead of creating every- thing from scratch. R&D services are helping reduce development time by allowing teams to focus on their strengths while outsourcing specialized tasks. Plat- forms such as Cas12l for gene editing, for example, offer tailored solutions for specific therapies, helping developers innovate faster," Paule states. Manufacturing is still key, with manufacturing phase up coupled with the scaling up of material sup- ply, process material preparation, process analytics, and quality control as well as all the systems required around all of these, asserts Jones. He points out that in- novation will be required with the greater production scales expected to be seen, and digitization seems a pre-requisite to maintaining quality, chain of identity, and security of process and process information. "We know from our conversations with therapy developers that manufacturing standardization and efficiency at scale is increasingly in demand and that innovation in industrial scale manufacturing can at- tract them to contract manufacturers, and robotics and digitalization play a huge part in this," Jones says. Meanwhile, Sagaert emphasizes what a real game changer integrated service offerings in the nucleic acid delivery space has become. "Being able to handle everything—from nucleic acid design and optimized production, through lipid design, to formulation, pro- duction, and quality control, supported by ex-vivo and in-vivo pharmacology services—opens a fast track to the clinic. When we started offering these services more than two years ago, people were still thinking that it only took an RNA and an LNP (lipid nanopar- ticle) to get to the clinic fast. However, we already knew that optimization was needed to get to the best product and open new fields of application. This now resonates a lot in the field," Sagaert explains. "I think that, rather than looking for where the next golden area is, we need to look at areas of im- provement in current service provider delivery," says Pashazadeh. Statistics from primar y research con- ducted by Treehill reviewing more than 1200 clinical programs has shown that, concerning performances of certain contract research organizations (CROs), "increased focus on delivering the services that are currently paid for can eliminate the 40% material data capture issues, the nine to 12 months of average study delay, and between 30–40% budget overspend," he states. "A highly select number of the CROs are focused on quality and on building a long term rela- tionship through genuine thought partnership and delivery excellence." Ellis echoes the importance of automation: "Whilst manufacturing is the greatest needed evolutionary step, the whole CGT sector is still teetering on a knife edge by using pen and paper. Each manufactured batch for each patient needs a qualified person to run through hundreds of form pages to enable release to the medical facility. Almost all other sectors across the global economy have adopted digitalization, bar the most advanced medical division in history. This leaves the entire sector with the cost burden of having to employ thousands of people to perform a task far more efficiently and effectively performed digitally." Capturing technology Christian Morello, the vice-president and head of the Bioconjugates Business Unit at Lonza, agrees from a CDMO perspective. In terms of needs, he remarks, the issue comes back to the expertise that's needed to be able to develop, address, and provide the best solution for the molecule in question. Referring to Lonza's 2023 acquisition of the Netherlands-based Synaffix (1), Morello says Lonza required Synaffix's antibody drug conjugate (ADC) technology platform because it brings value to the customer. As next-generation biotherapies grow more complex, drug developers are increasingly seeking specialized services.