Overview
Custom Manufacturing (CDMO Services)
As a contract development and manufacturing organization (CDMO), Agere Sciences provides integrated services that take your compound from concept to commercial supply. Our CDMO offering combines route design, process development, formulation and manufacturing to deliver high‑quality drug substance and intermediates. By partnering with Agere, you gain access to scalable manufacturing, regulatory expertise and an agile team committed to your project’s success.
Capabilities
01
Starting from a laboratory route or chemical concept, our chemists develop a robust, scalable process. We optimize parameters such as temperature, solvent selection and reaction conditions to maximize yield and minimize impurities.
02
Our facilities support scale‑up from gram to multi‑kilogram quantities under cGMP conditions. We perform technical transfers to ensure repeatability across scales and can produce pre‑clinical, clinical and commercial lots.
03
Analytical & Quality Control
In‑house analytical labs conduct method development and validation, release testing, impurity analysis and stability studies. Our quality assurance team oversees documentation and manages internal and external audits.
04
Regulatory & CMC Support
We prepare technical documents and CMC sections for regulatory submissions, and maintain alignment with ICH guidelines. Our regulatory experts collaborate with your team to address agency questions and facilitate approvals.
05
Formulation & Pre‑Formulation Services
Beyond the drug substance, we assist with pre‑formulation studies, solid‑state characterization and prototype formulation. Stability studies, method development and method validation ensure your product remains consistent throughout its shelf life.
Benefits
1
Agere offers a one‑stop solution for synthesis, scale‑up, formulation and manufacturing, reducing complexity and coordinating timelines across phases.
2
Whether you need milligrams for early research or kilograms for Phase II trials, we adjust our processes to suit your project’s needs. Custom scheduling and production slots accommodate urgent requirements.
3
Operating under cGMP and ISO‑aligned systems ensures your product meets regulatory and quality expectations. Our track record of successful audits and regulatory filings underscores our commitment to excellence.
Frequently Asked Questions
What types of compounds do you manufacture under your CDMO services?
We manufacture small‑molecule drug substances, intermediates, peptides, and certain oligonucleotides. Our services cover process development, scale‑up and cGMP production.
How do you develop and optimise manufacturing processes?
We begin with a laboratory route (from your team or developed by ours) and evaluate parameters like solvent selection, reaction temperature and reagent stoichiometry. We refine the process to maximize yield, control impurities and ensure scalability.
Do you provide formulation and pre‑formulation services?
Yes. We perform pre‑formulation studies, solid‑state characterization and prototype formulation. Stability studies and analytical method development ensure the final product maintains its quality over time.
What regulatory standards do you follow?
We adhere to cGMP and ISO quality systems. Our manufacturing facilities undergo regular audits, and we maintain complete traceability and documentation for regulatory compliance.
How do you handle scale‑up from laboratory to pilot to commercial scale?
After optimizing the laboratory route, we perform a series of scale‑up batches to confirm reproducibility. Our pilot plant supports up to multi‑kilogram quantities. For commercial production, we can continue in‑house or transfer the process to an external facility with a technology transfer package.
Can you handle highly potent or hazardous compounds?
We evaluate each project’s safety requirements. If appropriate containment and handling procedures can be implemented in our facility, we will work with potent or hazardous compounds; otherwise, we may recommend a specialized partner.
What is your approach to project management?
We assign a dedicated project manager who coordinates communication, timelines and deliverables. Regular updates ensure you have visibility on progress, and any changes are discussed promptly.
Do you assist with regulatory filings and CMC documentation?
Yes. Our regulatory team prepares CMC sections and technical documentation for INDs, NDAs or MAAs. We also support responses to agency questions and provide stability data, impurity profiles and batch records.
What are your lead times for CDMO projects?
Lead times depend on project scope and stage (pre‑clinical vs. clinical). Early development projects may range from weeks to several months, while clinical and commercial manufacturing can require longer timelines. We tailor schedules to meet your program’s milestones.
How do you ensure supply chain security and reliability?
We source raw materials from qualified suppliers, maintain safety stock where appropriate and evaluate alternative sources to mitigate risk. Our quality systems and vendor management programs help ensure consistent, reliable supply.
Ready to Start Your Project?
Considering a CDMO partner? Contact our custom manufacturing team to discuss your program. We’ll tailor a development and manufacturing strategy aligned with your objectives.