Guest Column | February 6, 2026

Leveraging Conventional Therapeutics Skills For Cell And Gene Therapy

By Geethashri Ananda, Ph.D., University of Pittsburgh

Female researcher analyzing scientific samples-GettyImages-2231025177

Cell and gene therapy (CGT) has evolved from a purely experimental field into one rapidly advancing toward large-scale manufacturing and commercialization, with dozens of products already receiving regulatory approval. This transition introduces a new set of challenges that extend beyond the digitalization of manufacturing, analytical, and quality management systems. As the industry scales, ensuring the safety, authenticity, and traceability of CGT products becomes increasingly complex.

However, developing a specialized workforce capable of managing highly sophisticated manufacturing processes while consistently maintaining rigorous quality standards presents a significant hurdle.1 To address this, the CGT industry can draw upon expertise from adjacent sectors, including medicinal plant-derived biotherapeutics, and established biologics platforms, such as mAbs and peptides. These fields offer valuable insights into manufacturing control strategies, quality systems, and workforce development that could help meet the growing demands of CGT production.

Although each platform relies on distinct technologies, they share a fundamental objective: translating complex biological systems into reproducible, safe, and efficacious therapeutic products. One of the most fundamental and broadly transferable challenges across these therapeutic modalities is the isolation of the true therapeutic “active substance” from highly complex biological matrices. This common challenge provides a natural and practical starting point for examining how skills and expertise can be transferred into CGT workforce development.

Isolating The Active Substance From Complex Biological Noise

Across therapeutic platforms, the challenge of isolating the true active substance from complex biological backgrounds is a defining feature of manufacturing. Medicinal plant biotherapeutics are derived from crude extracts containing hundreds of chemically diverse components, while biologics such as monoclonal antibodies are produced in host cell systems that generate a wide array of host cell proteins (HCPs), DNA, lipids and secretory byproducts. Similarly, CGT viral vectors (including AAV and lentivirus) are generated in biologically active production systems and must be separated from cellular debris and process-related impurities.

Plant extracts are inherently chemically complex and biologically variable, and drug discovery scientists often spend years mastering bio-guided fractionation strategies to remove hundreds of interfering compounds while preserving the stability and functionality of the active components.2,3 An analogous challenge exists in mAb manufacturing, where clinically viable antibodies must be isolated from complex mixtures of cellular macromolecules while systematically eliminating biologically irrelevant or potentially harmful materials.4,5 In CGT manufacturing, viral vector preparations are similarly accompanied by HCPs, nucleic acids, empty or partially filled capsids and, in some cases, replication-competent particles. Even non-viral vectors, despite simpler production or chemical synthesis routes, require rigorous purification to remove process-related contaminants such as residual solvents, unencapsulated cargo, or raw material impurities.6,7

As a result, downstream purification across all three platforms becomes an exercise in selectively enriching the functional therapeutic entity while maintaining its structural integrity and biological activity, whether that activity is pharmacological, binding-mediated, or transduction-based. This shared challenge closely parallels the experience of plant biotherapeutics and biologics scientists, who routinely work to isolate pure therapeutic compounds from extensive biological “noise.”

In plant extract-based therapeutics, analytical and preparative techniques such as high-performance liquid chromatography (HPLC) — including reversed-phase (RP-HPLC) for hydrophobic partitioning and size-exclusion chromatography (SEC) for molecular weight-based separation — are routinely employed to link bioactivity to specific fractions. These same chromatographic principles underpin mAb purification, where affinity capture, ion-exchange chromatography, and SEC are used to separate therapeutic antibodies from host cell–derived impurities.4,5 This purification mindset is directly transferable to CGT, where the objective remains the selective enrichment of functional vectors while preserving structural integrity and transduction efficiency.

Consistent with this trend, chromatographic separation methods in CGT have increasingly replaced legacy ultracentrifugation approaches.8 Affinity, anion-exchange, and SEC techniques are now widely applied to enrich functional viral vectors and to separate full from empty capsids, while RP-HPLC is frequently used to assess the purity of lipid components and nucleic acid payloads in non-viral systems. Despite differences in product class and biological complexity, these shared isolation and purification strategies highlight highly transferable skills, including matrix selection, mobile phase control, interpretation of elution profiles, and integration of chromatographic data with functional bioassays.8,9,10

Structural Characterization

Once therapeutically relevant components are successfully enriched and purified, robust structural characterization becomes essential to confirm identity, integrity, and suitability for downstream application. In medicinal plant-derived biotherapeutics, plant chemists employ infrared (IR) spectroscopy, Fourier-transform infrared spectroscopy (FT-IR), mass spectrometry (MS), and nuclear magnetic resonance (NMR) to determine the structures of bioactive phytochemicals.11 Similarly, biologics scientists rely on peptide mapping and amino acid sequencing via LC-MS/MS, along with higher-order structural analyses such as SEC, analytical ultracentrifugation (AUC), and dynamic light scattering (DLS) to assess mAbs.12

The conceptual skills developed in these contexts — particularly data interpretation, structural comparison, trend analysis, and problem solving — are directly transferable to the structural analysis of CGT products. In CGT, analogous techniques, including SEC-HPLC, ion-exchange chromatography, LC-MS/MS, AUC, circular dichroism (CD), and DLS are routinely applied to evaluate vector integrity, heterogeneity, and stability.13

Potency And Toxicity Assessment

However, structural confirmation alone is insufficient; functional relevance must be demonstrated through appropriate potency and toxicity assessments to ensure biological activity and safety. In medicinal plant-derived biotherapeutics and biologics development, scientists design and execute cell-based bioassays, such as cytokine inhibition assays (TNF-α, IL-1β, IL-6) and cytotoxicity assays, alongside in vivo pharmacological studies, to evaluate biological activity and safety.14,15 These competencies translate directly to CGT, where functional bioassays are central to product characterization and release.

For example, cytokine and cytotoxicity assays used in plant and protein biologics closely parallel CAR-T cell potency and safety assays, which assess target-specific cytotoxicity and cytokine release.16,17 Similarly, experience in in vivo pharmacology supports the design and interpretation of preclinical efficacy and toxicity studies for gene therapy candidates. Translating these functional insights into a reproducible and compliant therapeutic product further depends on robust aseptic practices, systematic process optimization strategies, and strict adherence to regulatory frameworks.

Aseptic Practices, Process Optimization, And Regulation

Proficiency in aseptic techniques and cleanroom behaviors has long been considered essential for sterile handling in plant-derived biotherapeutics and biologics workflows, and it is directly applicable to CGT manufacturing environments. Experience in optimizing process productivity, whether through extraction parameters for plant bioactive compounds or transfection conditions for biologic expression systems, fosters a problem-solving mindset that readily transfers to CGT production challenges, such as maximizing viral vector yields.

In addition, an understanding of how nutrients, growth conditions, and environmental regulators influence biological culture systems can inform media development and upstream process optimization in CGT manufacturing. Adherence to established traceability and regulatory cultures — such as good agricultural and collection practices (GACP), good agricultural practices for medicinal plants, and FDA/ICH guidelines for biologics — further reinforces the importance of documentation, quality control, and compliance within CGT operations.18,19

Conclusion

As CGT continues its transition from experimental science to large-scale manufacturing and commercialization, workforce development and technical skill transfer become increasingly critical. Methodological and conceptual competencies cultivated in medicinal plant biotherapeutics and biologics — including purification strategies, structural characterization, potency and toxicity bioassays, aseptic practices, process optimization, and regulatory compliance — provide a strong and directly relevant foundation for CGT research, development, and manufacturing. Leveraging these transferable skills can accelerate workforce readiness, reduce development risk, and support the sustainable growth of emerging CGT platforms.

References:

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About The Author:

Geethashri Ananda, Ph.D., is a GMP lead at the Immunologic Monitoring and Cellular Product Laboratory at the University of Pittsburgh. Previous roles include senior and leadership positions at Kemwell Biopharma Pvt. Ltd., Stempeutics Research Pvt. Ltd., and Bhami's Research Laboratory. She received her  Ph.D. from Nitte University and  M.Sc. from Mangalore University. Connect with her on LinkedIn.