Clinical Trial Manufacturing

Clinical Trial Manufacturing

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.

First in human (FIH) and Phase I clinical trials are typically designed to assess the safety, tolerability, and pharmacokinetics of the investigational drug in healthy volunteers. The study design includes determining the dose levels to be tested, the route of administration, the study duration, and the criteria for dose escalation or de-escalation. During the design of a study PharmSky can assist in the development of the active and placebo formulations 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.

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. 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.

All API, excipients, packaging, single-use process equipment and cleaning material to be used in clinical manufacture is handled following our GMP processes. If required, vendor qualification of suppliers can be completed. From the minute material arrives on our site, via delivery or manufacture, we receipt, store and manage it following detailed processes to ensure traceability throughout its life cycle up to and including despatch. We offer monitored ambient storage as well as qualified storage at the following conditions:

  • -20°C
  • 2-8°C
  • 25°C/60% RH
  • 40°C/75% RH

For more information see GMP Storage

Our pilot manufacturing facility is located in our Dandenong South site. The manufacturing laboratory is fully cleaned and sanitised following detailed procedures prior to completion of any manufacturing activities. Strict gowning, entry 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.

PharmSky have two laminar flow environments which are used during manufacturing to minimise product contamination. As much as is feasible all general manufacturing activities are completed in our laminar flow booth where filtered air is supplied through HEPA filters. For process steps such as sterile filtration or aseptic filling, where prevention of microbial and particulate contamination is vital, we use our laminar flow cabinet. This uses ULPA filters to provide air meeting or exceeding ISO Class 5 levels. Combined with clever modular process design, this equipment enables us to manufacture and supply material that is safe for use in humans.

PharmSky has a range of high-quality equipment that can be used for manufacturing simple and complex oral liquids, sterile injectables and topical formulations. PharmSky can also manufacture small scale solid and enteric coated capsules to support your FIH or phase I trials.
Where relevant, equipment has been qualified to verify that it performs to the standards required. We can also source appropriate single use equipment if required for a clients’ project. Reach out if you have any questions about PharmSky’s manufacturing equipment capabilities.

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. If blinded labelling is required, we also have experience managing this in a manner that ensures product traceability. Following labelling, product can be further packaged and prepared for despatch to the client or clinical site. This can be organised via suitably qualified providers if requested.
Our TGA certified analytical testing laboratory can complete all required in-process and physicochemical release testing using suitably qualified and validated instruments and test methods for drug substance, excipients, and drug product. Where required, sterility testing will be managed at a qualified external vendor. A Certificate of Analysis documenting compliance with the product specifications will be provided to enable you to release product for clinical use.

To support the lifecycle of the clinical trial, in alignment with regulatory requirements, or support post approval commercial product, 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.

For more information see ICH Stability Testing.

All manufacturing activities are fully documented in a batch protocol that is carefully prepared in conjunction with the client. Final approval for 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.

Our processes and facilities are supported by a robust internal audit program and are continuously improving as a result. We welcome all questions and client audits of our processes to ensure we can continue to supply clinical product meeting their requirements.

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