Oligonucleotide API Drug Substance Manufacturer
Oligonucleotide API manufacturer
Oligonucleotide therapeutics are a groundbreaking class of drugs with the potential to transform how we treat many diseases. They not only offer highly targeted therapies for previously unmet medical needs, but their applications also continue to expand beyond rare diseases into broader patient populations.
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 a required scale and quality according to customer demand and supply agreements.
Ongoing optimization of production to ensure efficiency and regulatory compliance.
Modifications & conjugates
- -F, -OMe, -O-MOE, -OH, -other
- Locked building blocks (LNA, cET, etc.)
- GalNAc
- Fatty acids
- Phosphates
- Linkers
- Phosphorothioate (PS)
- Phosphoramidate (PN)
- Vinyl & Methyl phosphonates
We are able to produce all standard conjugates
- Fatty acids
- Phosphates
- Linker-conjugates
- PEG
- GalNAc
using different conjugation chemistries
- Thiol-maleimide
- Click chemistry
- Disulfide formation
- SMCC-NHS
- Sulfo-SMCC-NHS
- BCN-NHS
- DBCO-NHS
- DPD-NHS
Thiol groups (e.g., cysteine) or azide functionalities on the peptide/protein (such as CPPs), along with amine groups, can be readily modified using appropriate linkers selected for the desired Oligonucleotide conjugation chemistry.
Why choose Bachem
Speed to market
Our streamlined processes, cross functional collaboration, and efficient project management ensure your product is delivered on time, in quality, and at scale.
Reliable partner with chemical expertise
We accompany you from preclinical development to commercialization, producing your high-quality, complex API.
An unmatched technology toolbox
From state-of-the-art synthesis to cutting-edge and sustainable manufacturing of the future, we’ve got your needs covered.
Reliable supply
We ensure your product remains competitive, compliant, and consistently available.
A partnership designed for the long run
Our collaborative model is built on transparent communication, dedicated project management, scientific depth across Oligonucleotides and a culture of innovation and continuous improvement.
Oligonucleotide production site in Bubendorf
Bachem’s Headquarters is our largest GMP hub for Peptide and Oligonucleotide production, advancing development and global supply.
Partner with Bachem for your Oligonucleotide API
Our streamlined processes, combined with highly efficient manufacturing, turn your project into high-quality and compliant Oligo products.
