Clinical Trial Manufacturing
Manufacturing Clinical Trial Materials
PharmSky’s pilot scale manufacturing facility can safely and rapidly manufacture clinical material suitable for early-stage clinical trials. Following the FDA’s cGMP guidance for Phase I Investigational Drugs and the PIC/S GMP Guide ensures that our manufacturing processes can prepare both sterile and non-sterile product suitable for administration to patients without risk to their health and safety.
Our Clinical Trials Testing Process
We offer clinical trial design tailored to the client’s scale for manufacturing both sterile and non-sterile first-in-human (FIH) and Phase I products. PharmSky’s state-of-the-art facilities and application of regulatory-compliant processes ensure the quality of all material manufactured and released from our site.
During the design of a study, PharmSky can assist in formulation development that may be required and we can prepare these on a large or small scale, as you require. We don’t put bounds on the minimum batch size and aim to work as closely as possible with clients to ensure a successful trial from the first to the last patient.
A selection of these are detailed below, however, if you have any questions about capabilities not listed, get in touch and we’ll see how we can help you. We are constantly expanding our services and introducing new manufacturing equipment.
GMP Storage
Our efficient quality system ensures hassle-free material receipting, storage and management, and despatch service for all API, excipients, packaging, single-use process equipment and cleaning material involved in clinical manufacture following our GMP processes.
See our GMP Storage service for our qualified storage capacity.
Facilities
Located in the Dandenong South site, our pilot manufacturing facility is fully cleaned and sanitised ensuring compliance with the principles of current GMP, relevant regulatory requirements, and internal procedures. Strict gowning, enter,y and ongoing cleaning controls are employed following laboratory preparation to minimise contamination during manufacture. All product contact equipment is cleaned and, if required, verified for cleanliness following approved procedures before and after use, with all activities fully documented.
Laminar Flow Environments
The modular laminar flow environment at PharmSky enables efficient contamination reduction across a wide range of manufacturing activities, for example, general formulating and compounding, sterile filtration, or aseptic filling
Manufacturing Equipment
PharmSky is fully equipped with advanced equipment to manufacture complex liquid dosage forms, including oral solutions and emulsions, sterile injectables, and topical formulations, each produced under strict quality and safety controls. Additionally, our expansion into solid dosage forms, such as tablets, capsules, and granules, is actively progressing to further enhance our production capabilities and meet diverse therapeutic needs.
Labelling and Packing
Following manufacture, we work with you and third-party service providers to design, print and apply labels meeting the Australian (or other as required) requirements for clinical labelling, including blinded labelling and traceability. Product packaging and despatch to the client or clinical site be organised via suitably qualified providers if requested.
Batch Testing and Release
Our TGA certified analytical testing laboratory offers a high capacity for required in-process and physicochemical release testing using suitably qualified and validated instruments and test methods for drug substance, excipients, and drug products. A Certificate of Analysis documenting compliance with the product specifications will be provided to enable you to release the product for clinical use.
Visit our Analytical Testing Services for more information.
Stability Testing
To support the lifecycle of the clinical trial, in alignment with regulatory requirements, or support post-approval commercial products, we can conduct stability trials and store and manage stability testing of your product. Following the conclusion of the trial, storage of retention samples can continue for as long as required.
See our GMP Storage and ICH Stability Testing for more information.
Documentation
All manufacturing activities are fully documented in a batch protocol that is carefully prepared in conjunction with the client. Final approval for the release of the material to the client by our quality assurance team is provided in this document. Supporting stability and testing activities are documented in appropriate test methods, specifications, and protocols.
Why Choose PharmSky To Partner With?
Partnering with our company for clinical trial manufacturing offers the advantage of a fully tailored process design, a highly adaptable manufacturing facility that can meet evolving needs, and comprehensive analytical testing services for both in-process monitoring and batch release, all backed by hassle-free labeling and packaging solutions to streamline your trial logistics and ensure seamless execution.
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Fast track your development with our extensive services. Get in touch so we can discuss your requirements.
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Frequently Asked Questions
We understand that clinical trials often require small-scale production runs with flexibility for scaling up. PharmSky can accommodate both quick-turnover small batch production (e.g. tens to thousands of units) for early-stage trials and larger-scale production as the trial progresses.
Two projects are never the same when it comes to CTM however as a general guidance, we expect a 3-6 month turnover inlcuding initial planning, tech transfer and process development, reciept of materials, manufacturing of clinical materials, quality control testing and batch release, and labelling and packaging. While the project complexity could ramp up quickly during the study, we work closely with the client through detailed planning, proactive risk management, and seamless coordination across all stages of manufacturing and regulatory processes
PharmSky can provide assistance throughout the whole manufacturing process, from pre-clinical formulation design, GMP excipient and raw material sourcing, material import/export, specialised equipment sourcing, test method and specification development, process design, label design and printing, manufacture, testing and release, GMP storage, quality and regulatory review and despatch.
If you require assistance with any or all of these aspects for your trial, we can help just get in touch.
