Clinical Development Oligonucleotide NCEs
Your partner for Oligonucleotide NCE manufacturing
Headquartered in Switzerland, Bachem delivers Oligonucleotide development backed by Swiss quality, precision, and long-standing pharmaceutical expertise.
150+
Ongoing CMC projects
1
GMP site for Oligonucleotides
40
Dedicated CMC project managers
Reach success with a bespoke plan
Advancing your Oligonucleotide API through clinical trials with platform‑ready analytical methods, structured process development, and a risk‑mitigated CMC framework built on decades of regulatory insight.
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Pre-clinical development
Pre-clinical development
Delivering material for toxicological studies, ensuring a smooth transition to clinical studies and scale-up.
Building a robust CMC foundation ensuring regulatory readiness, reliable manufacturing processes, and a seamless transition into early clinical development.
Method development for purity including peak purity and method suitability test to ensure high quality from start to finish through clinical phases.
The first production batches are used for feasibility, toxicology studies and early process development ensuring sound project setup, while the first GMP material is produced for Phase I.
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Clinical trial phase I
Clinical trial phase I
Building clinical confidence through robust first‑in‑human data and optimized scale‑up.
Refining and expanding initial CMC (Chemistry, Manufacturing and Controls) package with updated process, analytical, and stability data to ensure regulatory compliance.
Reliable early‑phase quality data and control strategy through validated purity methods, targeted developmental stability studies, and a sound strategy for critical starting materials.
Optimized manufacturing process for scale-up and a design batch to deliver the required API amount for phase I.
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Clinical trial phase II
Clinical trial phase II
Advancing analytical methods and production process to optimally support clinical phase II and prepare for future clinical and commercial supply of API.
Expanding and optimizing the CMC package with deeper process understanding, strengthened controls, and updated analytical data to support clinical phase II.
Further Definition of Control Strategy, continued method development and validation for release and IPC.
Advancing process design and characterization, and ensuring material supply for clinical phase II studies.
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Clinical trial phase III
Clinical trial phase III
Supporting pivotal studies with reliable large‑scale manufacturing, rigorous quality standards, and regulatory‑ready documentation.
Finalizing complete, compliant CMC Documentation that supports clinical phase III application.
Generating regulatory‑compliant stability data under ICH conditions to confirm product quality and support shelf‑life assignment. Finalize control strategy.
Finalize Process Risk Assessment and Characterization, compilation of MBPR and production of pre-PPQ batch to support Phase III studies.
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Market approval preparation
Market approval preparation
Ensuring API market approval readiness with robust regulatory documentation, compliant stability data, and validated commercial scale processes.
Preparation of regulatory documents to support application for market approval.
Generating PPQ batch stability data according to ICH requirements to support successful marketing authorization.
Completing process validation through PPQ documentation and three PPQ batches to confirm commercial readiness.
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Commercial supply
Commercial supply
Delivering consistent, compliant, and scalable commercial supply for long‑term access and market success.
Ensuring reliable, compliant commercial supply with ongoing quality oversight and regulatory support.
Robust delivery of API at required scale and quality according to customer demand and supply agreements.
Ongoing optimization of production to ensure efficiency and regulatory compliance.
Short timelines from project kick-off to first GMP material
Partnering with Bachem means gaining access to a proven, GMP‑compliant development pathway supported by deep analytical expertise, advanced engineering solutions, and a clear plan to bring your Oligonucleotide program efficiently and safely toward clinical milestones.
Depending on your molecule, we can deliver the first GMP batches within 9 month of project kick-off.
A commitment to reliable CMC development services
Analytical capabilities
We have an analytical team with vast experience in developing and validating test methods for large and structurally complex molecules, boosting confidence in technical reliability.
Customer centric project management
Dedicated project teams are assigned to NCE projects, led by experienced project managers to ensure coordination, confidentiality, and on‑time delivery, reinforcing reliability and professionalism.
Regulatory and quality
Bachem’s facilities are inspected by FDA, EMA, and Swissmedic, which is one of the strongest possible trust signals for pharmaceutical manufacturing.
Explore our latest in-depth materials
Risk management in clinical trials: A case study in API production
Building a successful Peptide or Oligonucleotide therapy takes more than innovation—it demands a structured CMC strategy that scales, stays compliant, and manages risk. This case study shows how Bachem helped a biotech partner streamline development, enhance manufacturing efficiency, and mitigate risks early using FMEA.
Greener purification at large-scale - an Oligonucleotide case study
Resembling a new era of innovative drug development, the interest of the biopharma industry in the Oligonucleotide markets has grown significantly in the past five years. In 2021, the US Food and Drug Administration (FDA) approved the first-in-class siRNA to lower cholesterol – a drug with a multi-ton potential to treat millions of patients per year. Moving forward, the demand for Oligonucleotide batch size is likely to increase as well as the need for large-scale manufacturing capacity to support this growth.
Why choose Bachem
Scalable manufacturing
We establish robust, scalable manufacturing processes to accelerate the path from development to market for Oligonucleotide-based APIs.
Advanced analytical expertise
Our analytical chemistry team brings deep expertise in developing and validating methods for structurally complex Oligonucleotides.
Regulatory confidence
We support IND and NDA applications with in-house regulatory specialists, ensuring smooth progression through regulatory milestones globally.
Sustainable production
A strong focus on sustainable, eco‑friendly manufacturing reduces waste, improves efficiency, and aligns with global environmental standards.
Swiss precision, global reach
Headquartered in Switzerland, Bachem delivers Oligonucleotide development backed by Swiss quality, precision, and long-standing pharmaceutical expertise.
Start your Oligonucleotide development journey with us
Specialized development and manufacturing Oligonucleotide APIs for clinical trials, backed by integrated analytical and regulatory support.
