White Paper

Strategies for Accelerating the Development of Modified Release Oral Forms

How do I scale up my product for commercial launch?

Quotient is your answer.

Pharmaceutical commercial manufacturing

Quotient Sciences is a global player in commercial drug product manufacture of small molecule products for niche therapies including oncology and orphan drugs. Our commercial manufacturing facility located in Philadelphia is designed to handle your high-potency compounds.

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.

Access Our High Potency Fact Sheet

Quotient Sciences High Potency Handling Capabilities

Quotient offers complete end-to-end services for the development and manufacture of highly potent compounds (HPAPIs) from Preclinical through to Phase III/Commercial Manufacturing.  When it comes to HPAPIs, we take an integrated approach to their handling and containment requirements which encompasses our facility design, engineering controls and operator safety.   

Access our latest data sheet to learn about our highly potent handling and containment capabilities and how Quotient can help support your HPAPI program by clicking here. 

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