GMP Manufacturing

Bringing nucleic acid therapeutics to the clinic requires more than scientific brilliance—it demands compliance, reproducibility, and regulatory strength. At Xoligo Biologics, our GMP manufacturing services are built to provide boutique agility with enterprise-level quality systems. We deliver the nucleic acid drug substance you need, backed by the documentation and traceability regulators expect.

We focus on Phase I–II readiness, offering the scales and processes that early-stage biotech companies require while ensuring a smooth transition into late-stage and commercial manufacturing.

Oligonucleotides Under GMP

Therapeutic oligonucleotides require exacting quality.

  • Scales – From grams to multi-gram clinical lots.
  • Modified Oligos – Backbone and sugar modifications (phosphorothioates, 2’-OMe, LNAs, conjugates).
  • Validated Workflows – Designed for reproducibility and regulatory compliance.
  • Batch Documentation – Full release packages aligned with ICH and FDA expectations.

mRNA GMP Supply

Messenger RNA is one of the most dynamic therapeutic modalities—and one of the most demanding to produce under GMP.

  • In Vitro Transcription (IVT) – GMP-controlled RNA synthesis with capping, poly(A) tailing, and sequence optimization.
  • Template DNA – GMP-grade plasmid backbones prepared with rigorous endotoxin control.
  • Purification & QC – Advanced HPLC, LC-MS/MS, and CE methods for clinical-grade purity.
  • Regulatory Documentation – IND/CTA support with complete CMC packages.

Scalable Systems

We design processes that scale with your program.

  • Early Clinical Supply – Agile systems for Phase I–II studies.
  • Transition to Late-Stage – Process development aligned to commercial requirements.
  • Comparability Studies – Ensuring data continuity as production scales.
  • Tech Transfer – Flexible models for partnering with late-stage/commercial CDMOs if required.

Regulatory Support

Our quality management systems are designed to withstand scrutiny from global agencies.

  • IND & CTA Submissions – Comprehensive CMC data packages.
  • Audit-Ready Documentation – Batch records, analytical data, and deviation tracking.
  • ICH & FDA Alignment – Processes developed to global quality standards.
  • Ongoing QA/QC – Continuous quality oversight for every production run.

The Boutique Advantage

Large CDMOs often treat early-stage clients as small projects in a crowded pipeline. At Xoligo Biologics, we take the opposite approach: every client is high priority. We bring the full strength of GMP compliance to smaller-scale production, giving startups and biopharma innovators a level of focus and responsiveness rarely found in large organizations.

With Xoligo, you don’t have to choose between boutique service and GMP-grade compliance—you get both.