Services
With our recently expanded R&D Laboratory and expansive supporting services, PTC is positioned to meet your project deadlines and support all your objectives of anti-cancer manufacturing technology. Whether you represent a small virtual group, global enterprise, or something in between, PTC will provide your program with world-class service and support.
PTC anti-cancer manufacturing technology services include:
Anti-cancer drug Pre-formulation & Formulation services:
At PTC, we have high experience in the pre-formulation and analysis of pharmaceutical anti-cancer active ingredients, including those that present formulation challenges. We can help with early-stage evaluation of the physicochemical properties of the new anti-cancer drug, carrying out the essential basics for optimising the formulation and anti-cancer drug delivery method. We can then create an anti-cancer product that is appropriate for our client’s needs, whether it requires a fit-for-purpose formulation for initial pre-clinical safety and efficacy studies, or a formulation strategy designed to help anti-cancer drug progress for clinical trial studies.
PTC's Pre-formulation & Formulation areas Include:
- Anti-cancer active ingredient stability profiling (including an evaluation of the effects of heat, light, and pH).
- Solubility profiling in buffers and non-aqueous solvents and determining the partition coefficient of an API.
- Compatibility testing of APIs and excipients.
- In vitro diffusion studies using Franz cells with synthetic and/or biological membranes.
- Rheology pre-formulation studies of liquids.
- Informal stability/formulation stress testing (both physical and chemical).
- Formulation and packaging compatibility studies.
- Tablet compaction analysis.
- Parenteral formulations for early-phase toxicity studies.
- Anti-cancer active ingredient characterisation studies such as particle size, DSC, TGA, powder X-ray diffraction, FTIR, and particle morphology.
Anti-cancer Scale-up & Technology Transfer:
At PTC Labs, we use a quality-driven approach to quickly complete the required formulation studies and move on to the scale-up process. Our typical approach for the scale-up process is that once a target formulation is selected and confirmed through our staff, the next step is scaling up the formulation while achieving the same critical product attributes. All scale-up process steps will be then carried out in our client manufacturing site which can guarantee the success of the process.
We in PTC validate our scale-up process prior to going ahead to manufacture the scale of commercial batches, and set specifications of process parameters such as flow rates, mixing speeds, hold times, etc. We use Quality by Design (QbD) principles and develop specific Designs of Experiments (DoE) to increase our success of scale-up.
Anti-cancer Manufacturing process Development services:
Manufacturing Process Development (MPD) services play a key role in ensuring an anti-cancer drug is adapted to a strong platform that is scalable and creates a blueprint that delivers optimal yields and productivity. Investing time and money in MPD services ensures the rapid development of the client’s manufacturing process that will accelerate the anti-cancer drug to market.
Industrializing anti-cancer drugs is a complex and challenging journey, which becomes more difficult when the constraints of equipment scalability are not considered early on in process development.
PTC will help clients evaluate batch versus continuous processing and will work with them to determine the right option for them and their anti-cancer product.
MPD services can help in developing a platform that can be deployed with multiple anti-cancer drug candidates. This saves both time and money since it will not be required to ‘re-create’ the wheel for each one of the anti-cancer therapeutics. Working with chosen PTC will help to adopt a platform that can deliver a complete, customized process which can improve process reliability and decrease facility footprint.
Anti-cancer Analytical Method Development:
Analytical method development supports anti-cancer product quality from an early phase of product development (R&D) through to manufacturing and post-marketing. PTC offers their clients of creating new analytical methods as well as developing the current analysis methods through up-to-date equipment and instruments.
Clinical Trial Manufacturing (CTM):
PTC ‘s experienced development scientists can formulate and produce the required quantities of clinical trial samples for all stages of the client molecule’s clinical development plan. From simplified anti-cancer dosage forms in the earliest clinical stages to critical registration batches, PTC scientists will optimize client anti-cancer formulation with a long-term development program in mind. This can allow PTC to scale the client product seamlessly through later phases of development and ultimately to commercialization.
