PHARMACEUTI
CAL
TECHNOLOGY
CENTRE ( PTC )
What is PTC….
◦ PTC is a specialized and advanced industrial pharmaceutical
research and development centre for pharmaceutical anti-cancer
drug formulation, process design, and manufacturing technology
development for new and generic small as well as macro-
molecule anti-cancer drugs in solid and parenteral dosage forms
which is based in England, UK.
◦ This centre will design and prepare all pharmaceutical industrial
studies that are required for all pharmaceutical companies that
are manufacturing or interested in manufacturing these anti-
cancer medicines for commercial use in their pharmaceutical
manufacturing firms.
◦ This centre can help cancer clinical research centres, cancer-
patient healthcare centres, and academic pharmacy colleges in
the universities locally and globally to cover all their needs from
formulated samples of anti-cancer drugs for pre-clinical, clinical,
and toxicity studies.
Our role as a Anti-cancer Drug Development Centre…….
PTC is a science-based centre and its
employees are scientists and pharmacists.
This gives the PTC an unusual skillset for
such a relatively small establishment. We also
collaborate with other not-for-profit
organisations by providing scientific support
for specific projects. By engaging the PTC to
act as a science centre, other not-for-profit
organisations lacking necessary
infrastructure or skills can realise credible
and successful projects that align with their
objectives.
What are the services that can PTC offer….
• Formulation and Process Development:
From First-in-Man studies to commercial launch, PTC will work with clients to
determine the most efficient and viable pathway for client anti-cancer drug
compound. PTC will prepare all pre-formulation and formulation studies for the
new anti-cancer drug molecules (small molecules and macromolecules) as well as
develop the existing anti-cancer medicines formulas for better stability, safety,
quality and effectiveness. PTC formulation development capabilities include
controlled release formulations. For poorly soluble compounds, PTC will offer a
variety of bioavailability enhancement technologies, including solid dispersion
development, and lipid-or macro/nano-based emulsions.
Applying the know-how of pharmaceutical nanotechnology to overcome the
limitations of formulation of current anti-cancer drugs to be more advanced anti-
cancer products that can treat cancer patients with more safety and effective
medicines. Molecular Envelope Technology (MET) will be utilized in my
formulation technology of anti-cancer drugs and is based on a proprietary
polymer with tightly controlled chemical properties engineered to form defined
nano-sized drug carriers.
• Pharmaceutical Analytical Method Development and Validation:
Analytical method development and validation are critical to pharmaceutical development and achieving the
reliable analytical data customer need to reach their next development milestone. Method development and
validation can be complex, costly, and labor-intensive.
A good understanding of current regulatory expectations and relevant chemistries coupled with advanced
instrumentation is critical to developing efficient, accurate, reliable analytical methods There are different types of
techniques of pharmaceutical analysis.
All these are meant to identify the quantity of a substance, determination of the structure of some specific chemical
compounds, and the components of the pharmaceutical formulation of anti-cancer drugs., PTC will also design and
execute detailed protocols for the full method validation, verification, and transfer — covering procedures for
pharmaceutical anti-cancer ingredients and a wide array of cancer drug formulations.
PTC will offer cost-effective strategic approaches to analytical method lifecycle management, which combines
method development, improvement, qualification, validation, transfer, and maintenance related to GMP
production.
PTC pharmaceutical analytical services will include:
- HPLC / UPLC testing with a wide variety of detection capabilities (UV, DAD, RI, CAD, ELSD,
ECD)
- Dissolution Testing (USP Apparatus I, II, III)
- Particle Size Determination by Laser Diffraction
- GC / Headspace analysis
- UV/VIS spectrophotometry
- FTIR spectroscopy
- Colour spectrophotometry.
PTC analytical laboratory is designed to perform the following studies in support of all stages of
formulation development such as:
- Early development stability
- Excipient compatibility
- Component compatibility
- Solubility Screening
- Thermal cycling and freeze-thaw studies
- Photostability Studies
• Aseptic Filling:
Sterile products are processed in strict accordance with cGMP requirements. PTC, with cGMP facilities located in
Manchester, will process all ready-to-use nested, vial, syringe, and cartridge formats for clinical and small batch
commercial applications, By using Small batch filling & closing machines, processes like vial filling, closing, and
sealing, Syringe filling and closing, Cartridge filling and closing, Lyophilizer integration all can be achieved. Also,
the aseptic process can attribute in personalized medicine and pilot-scale cGMP manufacturing.
• Clinical Trial Manufacturing service (CTM):
PTC will formulate and produce the required quantities of clinical trial samples of anti-cancer drug dosage forms
for all stages of clients’ molecule’s clinical development plan. From simplified dosage forms in the earliest clinical
stages to critical registration batches, PTC will optimize the client’s formulation with a long-term development
program in mind. This can allow us to scale the client’s product seamlessly through later phases of development
and ultimately to commercialization. PTC will offer its clients support through the entire CTM process. With
expertise ranging across dosage forms, PTC can guide clients through the full filing process. PTC will ensure the
transition from product development to CTM manufacturing is seamless and efficient. PTC’s manufacturing and
analytical laboratories will ensure clients can meet their targets.
PTC’s Clinical trial manufacturing and packaging services will include:
- Phase I, II, III & registration clinical supplies
- Full CTM formulation, manufacturing, packaging and release testing
- IND (Investigational New Drug Application) support documentation
- Full specification retesting and/or identification testing available at European sites for importation
into the EU from North American sites
- Full quality support for all clinical materials
