Manufacturing

At Maitland Labs, our team can help you avoid common hazards, and handle unexpected problems, often before they happen. That is the benefit of experience: Whatever challenges your program may face, chances are very good that we have seen something similar and know how to handle it.

Is line loss an issue? No problem, many of our clients are working with very limited or expensive drug substance or drug product, and we can ensure minimal line losses to protect your API and your money without compromising quality. Depending on your required fill volume, our batch size minimums start at only a few hundred vials.

Tell us about your project and tell us about what you are trying to accomplish. Our team will help you design a program to make it a reality, and better still, while keeping a close eye on budgets and timelines. It’s what we do everyday, and it’s why our largest source of new business is referrals from existing and former clients.

We currently work with most standard vial sizes and we can also accommodate your custom filling requirements. Some of the services that we provide are as follows:

  • Aseptic fills –800 sq. ft. clean room that meets FDA and EU air quality standards.

  • Terminally sterilized products– Dedicated ISO 7 controlled manufacturing space for filling
    operations.

  • Hazardous drug formulation space – dedicated room for formulating drug listed as hazardous by NIOSH National Institute for Occupational Safety and Health

  • Tech Transfer – If your process is not suited for larger scale manufacturing, we can help with scale
    up and optimization to comply with cGMP.

All products are inspected for quality defects. Labeling can also be applied to the finished vials. For smaller studies, we can also assemble kits for direct shipment to clinical sites.

Support Services

In support of our manufacturing operations, Maitland offers the following analytical services:

  • Microbiology

  • Cleaning verification and validation

  • Drug substance and reference standard material characterization

  • Method development and Validation

  • High performance liquid chromatography (HPLC)

  • Particulate matter analysis (USP <788>)

  • QC Analysis

  • Container closure integrity testing

  • Stability assessment

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Maitland Labs – Innovative approaches to the development and production of new and existing sterile drugs.