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Webinars & Whitepapers

Explore expert perspectives on oligonucleotide manufacturing, regulatory considerations and bioanalysis.

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Webinars

Mastering Manufacturing Challenges in Oligonucleotide Production - From Process Development to Commercial Solutions

WEBINAR

Mastering Manufacturing Challenges in Oligonucleotide Production - From Process Development to Commercial Solutions

Case studies on guide RNA synthesis, cleavage and deprotection scale-up, HPLC purification control and API concentration. Explore process development approaches for clinical and commercial oligonucleotide manufacturing.

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High Concentrations Made Easy: BioSpring's Next Level UF/DF Method for Improved Oligonucleotide API Manufacturing

WEBINAR

High Concentrations Made Easy: BioSpring's Next Level UF/DF Method for Improved Oligonucleotide API Manufacturing

Learn how BioSpring’s UF/DF method addresses oligonucleotide concentration limits before lyophilization and in solution API manufacturing.

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Regulatory Feedback On Late-Stage Programs - A CDMO Perspective

WEBINAR

Regulatory Feedback On Late-Stage Programs - A CDMO Perspective

A CDMO perspective on molecule classification, process validation, release specifications and analytical method validation for Phase III and commercial oligonucleotide programs.

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Whitepapers

One Partner, Every Phase

WHITEPAPER

One Partner, Every Phase

Navigating the market journey of your therapeutic oligonucleotides. Explore CDMO selection, technology transfer, analytical continuity and GMP readiness, with case studies from development through commercial supply.

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Top Six Considerations for Taking Oligonucleotide Therapies from Clinical to Commercial Supply

WHITEPAPER

Top Six Considerations for Taking Oligonucleotide Therapies from Clinical to Commercial Supply

Six considerations for the transition to commercial supply: regulatory engagement, specifications and impurity control, early CDMO involvement, process characterization, scale-up and lifecycle management.

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Enabling Therapeutic Progress with Oligonucleotide Bioanalysis

WHITEPAPER

Enabling Therapeutic Progress with Oligonucleotide Bioanalysis

Compare hELISA, qPCR and LC-MS/MS for oligonucleotide quantification in biofluids and tissues, and explore BioSpring’s LC-MS/MS approach using isobaric internal standards.

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Analytical Strategies for Diastereomers in Oligonucleotide Development

Phosphorothioate linkages are widely used in oligonucleotide therapeutics, but the resulting diastereomeric complexity presents important analytical and manufacturing considerations. This webinar explains why diastereomer distributions matter and introduces analytical approaches for their characterization, including HPLC fingerprinting, ³¹P NMR, and shortmer studies. Attendees will gain deeper insight into fingerprint methods and their application to the characterization and comparison of complex diastereomer mixtures.

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Mastering Manufacturing Challenges in Oligonucleotide Production - From Process Development to Commercial Solutions

As oligonucleotide programs advance toward clinical and commercial supply, manufacturing processes must address increasing complexity across molecule types, modifications, and batch sizes. This expert presentation explores practical approaches to key manufacturing challenges in therapeutic oligonucleotide production, including guide RNA synthesis, cleavage and deprotection scale-up, stereoisomer control during HPLC purification, and API concentration before lyophilization or solution API manufacturing.

In this TIDES USA spotlight presentation, Sven Warhaut, Ph.D., shares BioSpring’s perspective on how targeted process development and manufacturing improvements can help support demanding oligonucleotide programs from early development through commercial supply. The presentation highlights selected case studies, including scalable guide RNA manufacturing, representative scale-down models for process development, analytical strategies for purification control, and osmolyte-assisted UF/DF for high-concentration API manufacturing.

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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.

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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.

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Whitepapers

One Partner, Every Phase

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

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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

 

 

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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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