Explore our growing library of expert-led webinars and in-depth whitepapers. This section highlights BioSpring’s dedication to knowledge sharing and continuous learning within the scientific community. Whether you’re seeking to deepen your technical understanding or stay ahead of emerging developments, our curated resources offer valuable perspectives to inform and inspire.
Webinars
High Concentrations Made Easy: BioSpring's Next Level UF/DF Method for Improved Oligonucleotide API Manufacturing
Ultrafiltration is widely used in oligonucleotide manufacturing, particularly for the desalting and concentration of active pharmaceutical ingredients (APIs). With traditional ultrafiltration, the concentration that can be achieved is limited. This creates a significant bottleneck in the production of powdered APIs, where ultrafiltration is frequently used as a pre-lyophilization step and determines the maximum batch size that can be obtained with the freeze dryer capacity. Moreover, traditional ultrafiltration often cannot support the manufacturing of oligonucleotide solution APIs because it fails to exceed the concentration of subcutaneous drug products. To address these issues, BioSpring has developed an in-house ultrafiltration/diafiltration (UF/DF) technique, optimizing nucleic acid concentration and enhancing production efficiency.
Regulatory Feedback On Late-Stage Programs - A CDMO Perspective
Advancing an oligonucleotide therapeutic into late-stage development presents unique challenges, requiring a well-defined regulatory and validation strategy. This talk provides key insights from a CDMO perspective on molecule classification, process validation steps, regulatory expectations, and the role of release specifications. Additionally, it highlights best practices for analytical method validation tailored to Phase III and commercial programs, ensuring regulatory compliance and product success.
Navigating the market journey of your therapeutic oligonucleotides
Whether you are advancing an oligonucleotide therapy from early development into the clinic, preparing for GMP manufacturing, planning a tech transfer, or building commercial supply, each phase brings critical decisions. Multiple vendors, changing manufacturing processes, evolving regulatory expectations, and inconsistent analytical methods can increase risk, add complexity, and delay progress.
This whitepaper explores how you can:
Navigate key development risks in therapeutic oligonucleotide programs, from early-stage material supply to clinical and commercial GMP manufacturing
Understand how a single CDMO partnership can help reduce tech transfer burden, maintain analytical consistency, and support GMP readiness
Evaluate CDMO selection criteria, including scalability, regulatory support, impurity control, supply chain resilience, and long-term program fit
Learn from selected BioSpring case studies covering accelerated GMP onboarding, late-stage tech transfer, process validation, and commercial readiness
Top Six Considerations for Taking Oligonucleotide Therapies from Clinical to Commercial Supply
Taking an oligonucleotide therapy from clinical development to commercial supply is a critical transition. As programs move toward GMP oligonucleotide manufacturing at commercial scale, regulatory expectations intensify, quality requirements tighten, and reliable large-scale production becomes increasingly important. Decisions around specifications, impurity control, process validation, scale-up, and lifecycle management can directly affect time to market and long-term product success.
This guide highlights key considerations around:
Early regulatory engagement before PPQ and commercial validation
Defensible specifications and suitable impurity control
Early CDMO involvement to support planning, scale-up, and execution
Robust process design and characterization
Scale-up readiness for commercial manufacturing
Method and process lifecycle management after launch
Enabling Therapeutic Progress with Oligonucleotide Bioanalysis
Whether you are seeking regulatory approval, evaluating drug metabolism, or planning your next clinical phase, it is crucial to have reliable data when analyzing oligonucleotidebased drugs and their metabolites in biofluids and tissues. Oligonucleotides like ASOs, siRNAs, and guide RNAs bring unique challenges: diverse chemical modifications and conjugations, complex degradation pathways, and interfering sample background make standard bioanalytical methods unreliable or insufficient. Accurate bioanalysis requires tailored analytical strategies that account for this complexity.
This paper explores how you can:
Navigate the bioanalytical challenges of oligonucleotide therapeutics through strategic method selection
Evaluate key quantification techniques, including hELISA, qPCR, and LC-MS/MS
Benefit from BioSpring's tailored LC-MS/MS method using isobaric internal standards, designed to deliver high sensitivity specificity, and reproducibility across various oligonucleotide types in different biofluids and tissues
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