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
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 and banded. Matching placebos can be formulated and manufactured for comparative studies.
Process development, scale-up, technical transfer
Manufacturing process development to ensure effective scale up from <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 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
Ability to manufacture unique delivery forms such as bi-layer, tri-layer tablets, as well as thin film strips for oral delivery. Unique expertise with modified & controlled release, in addition to taste masking of bitter compounds. Capabilities also include potent compound manufacturing & 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.
Process Development
CoreRx drug development scientists will develop and optimize a manufacturing process that can be scaled up efficiently and successfully within our cGMP facility or yours. Elements of the process may include any of the following and more.
Manufacturing Process Services
 Blending/homogenization
Filtration
Filling
Container/closure selection
Lyophilization
Manufacturing Scale Up and Tech Transfer
Upon successful completion of the development of the manufacturing process, CoreRx will proceed with the scale-up for final manufacture. A technical transfer can be initiated for manufacturing processes into the client site or third party commercial manufacturing facility. To facilitate the transfer process, CoreRx offers on-site oversight of full batch production (if requested).
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