Commercial Manufacturing
How do I scale up my product for commercial launch?
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Pharmaceutical commercial manufacturing
Our commercial batch size capabilities include:
- Up to 500kg for solid oral dosage forms
- Up to 350L for liquid formats using an automated filling line
In addition to manufacturing products for NDA, ANDA, MAA and JNDA registration, the Quotient team can support 505(b)(2) and CBE-30 filings.
Process validation and registration batches
Whether you are preparing for NDA, MAA or Japanese NDA, Quotient has the expertise and regulatory approval to manufacture your validation and registration batches for the U.S., U.K., Europe and Japan.
Phase III and commercial drug product supply
Quotient can support all aspects of your drug product supply for Phase III clinical studies and commercial supply.
- Manufacture of all oral drug product dosage forms in our FDA-, EU- and PDA- approved facilities
- Packaging including bottles, blisters, tubs or tubes
Dosage forms
Quotient has vast experience across an array of dosage forms that we manufacture for registration and commercial supply, including:
- Solid oral dosage forms
- Oral solutions and suspensions
Project management
Quotient Project Management has over 30 years of experience in supporting drug programs that are in late stage development and commercial. Our project managers will ensure your commercial readiness by providing end-to-end support from concept and project scoping, to project delivery. And where projects transition across our sites, or intersect with other service providers, we’ll make the process seamless for you. For more information about Quotient Project Management, click here.
High-potency API handling
Using our experience across the industry pipeline, Quotient has responded to the challenges associated with the manufacturing of today’s high-potency drug products by ensuring our facilities are capable of handling compounds with a maximum performance-based level of exposure classification.
When you need commercial manufacturing for a simple or complex drug product, Quotient is your answer.
Learn more
Access our resources
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Info SheetGlobal Formulation Development and Manufacturing CapabilitiesWe provide full service support for small molecule non-sterile programs, from dosage formulation development through to GMP clinical trial manufacturing and commercial drug product supply.
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Case StudiesEndevica Case Study - Peptide Program using Translational PharmaceuticsEndevica Bio is developing TCMCB07 as a novel synthetic peptide product for the potential treatment of cachexia. Read how they leveraged the Quotient Sciences Translational Pharmaceutics platform for this program.
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Case StudiesEnsysce Biosciences Case StudyRequest a copy of our latest case study with Ensysce Biosciences about how our integrated strategies helped them achieve their regulatory milestones faster for PF614-MPAR, an Extended Release product.
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Info SheetDrug-Drug Interaction (DDI) StudiesAssessing how your drug interacts with other drugs in vivo is a critical step in the drug development process and is essential in ensuring safe and efficacious drug delivery. This assessment is known as a drug-drug interaction (DDI) study and is a regulatory requirement for submissions of investigational new drugs (INDs). Learn more about Quotient Sciences' offering for DDI studies.