Commercial Services

Choosing a reliable commercial supply partner with proven expertise in manufacturing products for your markets, product type and scale is critical to commercial timelines and product success. Whether we are evaluating your project at the tech transfer stage, or have been partnering with you since early development, Metrics offers turn-key services and support for novel oral solid dose drug products.

These services include formulation development, process optimization, analytical method development, qualification, validation and testing, drug product manufacturing, regulatory guidance, packaging and serialization.

Our Commercial Manufacturing (CMO) services include
  • Pre-registration services to prepare your product ahead of registration and ensure a successful transition from clinical to commercial
  • Risk assessment and a structured technical transfer process with early engagement from our experienced technical services team
  • Manufacturing your most complex, novel OSDs, from small batch sizes up to 450kg that are ideal for orphan drugs to commercial-scale highly potent compounds in our purpose-built manufacturing facility with a production history of commercial products for major markets
  • Ability to commercial pack in bulk, or package and serialize into bottles or blisters.

De-risk your commercial manufacturing with:
  • A jointly developed product scale-up plan with early engagement from our tech transfer team,
  • Experience manufacturing and packaging over 35 commercial products,
  • Access to a purpose-built facility (>$80M recently invested for capital expansion) with a proven track record of launching global commercial products into major markets.
  • Our strong regulatory inspection history and “one campus, one project team, one FDA site registration” approach to early phase through commercial.
Flexible Services, One FDA Registration

When you have a high value, low volume drug product for niche patient populations, it can be difficult to find a partner with the level of agility and adaptability to ensure your products success. At Metrics, our team has the expertise, flexibility and a state-of-the-art facility that can handle challenging projects that require custom processes and solutions. Our scientific excellence is supported by robust operational readiness with best-in-class equipment and a strong compliance record.

Specifically designed for containment, our facility can manage commercial-scale manufacturing of highly potent compounds and we specialize in handling small batch sizes ideal for orphan drugs. Our clinical, analytical, development and commercial services are co-located on one site under a single FDA registration, ensuring efficient transfer and scale-up from clinical phase production through to commercial manufacturing.

Our Commercial Manufacturing (CMO) services include:

• Production of immediate and modified release and multiple-unit pellet systems (MUPS) oral solid dosage forms
• Production of registration and process validation batches
• Technical transfer of products into a world-class manufacturing facility by an experienced technical services group
• Commercial batch sizes up to 450kg
• Dedicated Quality Control Laboratory
Unwavering Quality

We employ the quality systems, oversight and manufacturing expertise that have ensured over a decade of successful commercial manufacturing and an exemplary track record of global regulatory compliance.

Throughout our partnership, you’ll be supported by experienced commercial quality assurance, operations, quality control, supply chain, and warehousing teams.

A dedicated account management group works diligently to facilitate client engagement and communication.

Novel OSD

We strive to use best-in-class equipment throughout our commercial manufacturing operations:

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Do you need a partner that can solve your most pressing novel oral solid dose challenge?

Talk to Metrics.