Issue link: https://www.e-digitaleditions.com/i/1532595
10 Pharmaceutical Technology ® | BioPharm International ® Bio/Pharma Outsourcing Innovation February 2025 PharmTech.com NE X T-GENERATION THERAPEUTICS "[The company's] technolog y is a new way to do conjugation where we are connecting the linker at the glyco location in the mAb [monoclonal antibody]. This is something that no one else has, and this is a technology that addresses specifically the challenge of the number of linker and payload you can connect to the mAb," Morello states. Noting that there are multiple needs to be met in next-generation biotherapeutic development and manufacturing, Morello emphasizes that Lonza fol- lows on a daily basis the evolution of technologies that can serve this sector. Lonza has created a toolbox in which it has captured new technologies, such as Synaffix's ADC platform, to bring the best solution to customers. "[Lonza] is basically identifying very in- novative companies, bringing them into its network, identifying where the customer may require this type of support, and then facilitating and connecting this technology at an early stage," Morello explains. Capturing partnerships With the drive to outsourcing prompted by increasingly complex manufacturing processes, Alexander Seyf, CEO, Autolomous, underlines the needs of next-gen- eration biotherapies, especially their requirements for specialized facilities, equipment, and expertise that, as mentioned earlier, may not be in the purview of many biopharma companies' in-house capabilities, especially smaller companies. "Outsourcing allows them to access these resources without the substan- tial capital investment and time required to build them internally," states Seyf. Beyond manufacturing complexit y, Seyf identi- fies several other trends that are driving increased outsourcing such as cost containment, focus on core competencies, access to specialized expertise, f lexi- bility and scalability, accelerated development time- lines, global reach, and risk sharing. Pa sh a z adeh obser ves t h at a hea lt hy dy n a m ic among outsourcing partners is created when there is a clear understanding of why a study is being consid- ered, a focus on the optimal way to run it, outlining the pathway to delivery, a timeline of achievability, and taking accountability on delivery. "In the 1200 studies that Treehill reviewed, there were material areas of improvement in over half of the cases. There are very few providers for whom the primary focus is on ensuring the correct study is run with a high degree of focus on quality delivery," he notes. Strong par tnerships are built on transparenc y, shared goals, and technical synergy, explains Paule. "Aligning expectations on timelines (milestones), qual- ity standards, and regulatory requirements is crucial for avoiding roadblocks. Flexibility is also key, as scien- tific and regulatory landscapes are constantly evolving. One common pitfall is underestimating the complexity of scaling new technologies, so choosing a trustworthy partner who will support you and take an active inter- est in your success is essential," Paule emphasizes. Reference 1. Lonza. Lonza to Acquire Synaffix and Strengthen Antibody-Drug Conjugates Offering. Press Release. June 1, 2023. For more videos, visit PharmTech.com! Nigel Theobald CEO N4 Pharma Dan Strange, PhD Chief Technology Officer Cellular Origins Drug Digest: Challenges and Triumphs in Next-Generation Biotherapeutic Development The development of next-generation biotherapeutics is in full swing, which means that developers and biomanufacturers are tackling new challenges in the drug development and manufacturing lifecycle. Two areas of focus are in the maintenance of an aseptic environment throughout the manufacturing process and the search for solutions to establishing alternative drug delivery methods that don't require a parenteral route of administration. In this episode of Drug Digest, experts from N4 Pharma and Cellular Origins discuss their experiences in dealing with these challenges, as well as triumphs in creating innovations to move the industry as a whole forward. Drug Digest is a tech talk video series with the editors of Pharmaceutical Technology®, who interview industry experts to discuss the emerging opportunities, obstacles, and advances in the pharmaceutical and biopharmaceutical industry for the research, development, formulation, analysis, upstream and downstream processing, manufacturing, supply chain, and packaging of drug products. https://www.pharmtech.com/view/drug-digest-challenges-and-triumphs- in-next-generation-biotherapeutic-development