The term biologics refers to a class of therapeutics produced using living organisms.1 Although biologics have been used in the clinic for over a century, their prominence has grown exponentially over the last few decades. This popularity has been powered by advances in cell culture, gene editing, and recombination technology that have greatly expanded biologics discovery and mass production capabilities.2
The Benefits of Multimodality
Biologic agents themselves have also become more complex, going beyond simply producing naturally occurring macromolecules to altering or modifying them for increased efficiency or more specific targeting.3 Today’s biologics are multimodal: They incorporate or combine multiple distinct elements for improved function. For example, antibody-conjugated drugs combine the specific targeting of an antibody with the cytotoxicity of a small molecule drug, while chemically-modified peptides possess modified moieties designed to alter or enhance functionality.4,5 Indeed, biologic components can run the gamut from cells to proteins and nucleic acids, and their production and delivery can further involve viruses, bacteria, and nanoparticles.
Multimodal drugs can offer significant advantages in terms of bioavailability, activity duration, targeting specificity, efficacy, and even production efficiency. However, producing multimodal drugs requires interdisciplinary collaboration. Multimodal drug manufacturing may require experts from pharmacology, biochemistry, cell biology, chemistry, biotechnology, and nanomaterial engineering, just to name a few possibilities. However, scientists in different areas tend to work independently of each other, with each field developing their own specific standard operating procedures (SOP) not just with regard to workflows, but also when it comes to notekeeping, data collection, and data management.
Digital Data Solutions
Good recordkeeping is essential to maintaining experimental consistency and enabling accurate data analysis,6 two things that are absolutely vital in biopharmaceutical research and manufacturing. Digitization enables good recordkeeping, proving vital for aggregating, collating, and organizing data from different sources and stored in different formats. This, in turn has spurred digitalization—finding value in digitization beyond simply changing the knowledge storage medium. Many laboratories now turn to electronic lab notebooks (ELN) and laboratory information management systems (LIMS) to streamline their operations. ELN are systems designed to create, store, retrieve, and share electronic records in compliance with legal, regulatory, technical, and scientific needs, while LIMS serve as digital tools for sample, inventory, workflow, SOP, and data management.6,7
Digitalization, while unquestionably helpful in streamlining workflows, research, and manufacturing, has also led to the development of a large and varied host of different ELN and LIMS options. Without a well-defined gold standard, not only might two fields differ when choosing their preferred data management software systems, but their systems may not be compatible, making it difficult to transfer data from one to the other. Furthermore, software may simply not be compatible across different fields—a suite designed to handle small molecule databasing might not be capable of handling information on peptides and macromolecules. As a consequence, moving data from one part of a multimodal project to another remains problematic.
Unifying Laboratory Informatics
Scientists are working to resolve these issues. New laboratory informatics platforms can manage and track entries across multiple fields. For example, Sapio Sciences platforms possess Multimodal Entity Registration, a single system that can manage data on both natural and non-natural biologics, including all forms of conjugates, peptides, and small molecules. Further, the system automatically tracks entity and component part lineage across a workflow on a sample-by-sample level. As a result, Sapio Sciences’ informatics platform works as both an LIMS and an ELN, and Multimodal Entity Registration capabilities mean that a given therapeutic entity can be entered into the platform and viewed by any user of the system in the most appropriate way (e.g., whether as a molecule or using a Hierarchical Editing Language for Macromolecules (HELM) viewer). The platform is also fully integrated with Sapio Sciences’ existing LIMS and Electronic Lab Notebook platforms. It is also fully cloud-based, requiring nothing more than an up-to-date web browser to use.
Modern laboratory informatics software suites like those from Sapio Sciences, with their Multimodal Entity Registration capabilities, strive to combat siloing, enable integration, and provide flexibility in drug discovery, research, and development—all so that scientists can keep pace with and accelerate the rapidly evolving disease research landscape.
- Revers L, Furczon E. An introduction to biologics and biosimilars. Part I: Biologics: what are they and where do they come from?CPJ. 2010;143(3):134-139.
- Morrow T, Felcone LH. Defining the difference: What makes biologics unique. Biotechnol Healthc. 2004;1(4):24-9.
- Wang L, et al. Therapeutic peptides: current applications and future directions. Sig Transduct Target Ther. 2022;7:48.
- Fu Z, et al. Antibody drug conjugate: the “biological missile” for targeted cancer therapy. Sig Transduct Target Ther. 2022;7:93.
- Naowarojna N, et al. Chemical modifications of proteins and their applications in metalloenzyme studies. Synth Syst Biotechnol. 2021;6(1):32-49.
- Argento N. Institutional ELN/LIMS deployment: Highly customizable ELN/LIMS platform as a cornerstone of digital transformation for life sciences research institutes. EMBO Rep. 2020:4;21(3):e49862.
- Machina HK, Wild DJ. Laboratory informatics tools integration strategies for drug discovery: integration of LIMS, ELN, CDS, and SDMS. J Lab Autom. 2013;18(2):126-36.
