Clinical Trial Materials (CTM) Manufacturing
CoreRx™ offers diversified technical resources, capacity, flexibility, and the experience to develop and manufacture virtually any clinical dosage form with strict quality compliance. Further, our optimized processes create additional value for future commercial scale-up.
Your Bottom Line
At CoreRx our goal is to move quickly and efficiently from preclinical into clinical development. During the development process, CoreRx will propose a manufacturing schedule for clinical trial supplies, based on your needs and API availability. CoreRx supports clinical trial material manufacturing in support of Phase I-III development.
cGMP manufacturing, packaging, and labeling of various dosage forms
Pharmaceutical manufacturing in support of Phase 1-3 clinical supply needs, for solids, liquids, semi-solids, topical, including packaging and labeling in blisters packs, bottles, and tubes.
Comparator supplies (over encapsulation)
Comparator Supplies - Products can be blinded for clinical studies using over-encapsulation. Matching placebos can be formulated and manufactured for comparative studies.
Coating tablets and capsules
CoreRx offers a variety of tablet and capsule coating techniques including but not limited to Wurster coating and Tan coating.
Process development, scale-up, technical transfer
Pharmaceutical manufacturing process development to ensure effective scale up from less than 1kg to multi-kilo batches, and transfer of manufacturing processes to client or third party site.
Full cGMP compliance, accountability and document traceability
Compliant with Title 21 CFR part 11, all data 100% inspected and quality audited to ensure full cGMP manufacturing compliance.
Manufacture matching placebo for clinical studies
In support of blinded clinical studies, CoreRx provides batch manufacturing of placebo matching the appearance of active containing batches.
Process qualification, cleaning verification
CoreRx follows the FDA guidance and incorporates appropriate elements of process validation for the manufacture of human and animal drug products. Additionally, cleaning verification studies are conducted and fully documented for each process.
Optimizing process operations
Improving the process for manufacturing the dosage forms, especially with oral solids, involves manipulation of particle size of active, as well as excipients. While larger particles flow well, smaller particles improve dissolution and absorption.
Innovative manufacturing capabilities for challenging products
CoreRx has the ability to manufacture unique delivery forms such as bi-layer and tri-layer tablets. Unique expertise with modified and controlled release, in addition to taste masking of bitter compounds. Capabilities also include potent compound manufacturing and DEA controlled drugs.
Ability to customize manufacturing to client demands
From drug development to manufacturing and packaging of clinical supplies, CoreRx keeps open scientific communication to ensure that every client need is met. Whether it is dosage aesthetics, special packaging requirements, or fast-track timelines, CoreRx will meet and exceed your expectations.
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