IActive Pharmaceutical Ingredients (APIs) are the active substances used in the formulation of final drug products and these final formulations can have a single API or multiple APIs. APIs can be manufactured by processes such as (1) chemical synthesis; (2) fermentation; (3) recombinant DNA or other biotechnology methods; (4) isolation/recovery from natural sources; or (5) any combination of these processes. PharmaSynth has core competencies in all of these technologies and particularly in custom chemical synthesis. Visit: http://www.pharmasynth.com.au/
1. Custom Chemical Synthesis
Active Pharmaceutical Ingredients (APIs) are the active substances used in the formulation of final
drug products and these final formulations can have a single API or multiple APIs. APIs can be
manufactured by processes such as (1) chemical synthesis; (2) fermentation; (3) recombinant DNA or
other biotechnology methods; (4) isolation/recovery from natural sources; or (5) any combination of
these processes. PharmaSynth has core competencies in all of these technologies and particularly in
custom chemical synthesis. PharmaSynth can offer to our clients GMP chemical synthesis for a range
of chemistries including:
Glass & stainless steel reactors up to 150L
Chemical and solvent handling infrastructure
Research quantities to Kilo lab capabilities
Carbohydrate chemistry expertise
Traditional organic synthesis expertise
Natural product extraction and purification
Also because of extensive experience in biopharmaceuticals due to the contract services that we
provide in the microbial fermentation of recombinant molecules, PharmaSynth can also produce
compounds such as those required in new types of therapy that combines innovations from both
biotechnology and chemistry such as the production of antibody drug conjugates.
Custom chemical synthesis is a business operation conducted by a third-party vendor, typically a
stand alone contract manufacturing organization (CMO) or a operating unit of a large chemical
company that builds molecules on the behalf of a specific customer. Although it is often associated
with fine chemicals or the life science industry, custom synthesis covers the full gamut of the chemical
industry.
Custom chemical synthesis ranges the production of molecules produced at the microgram scale to
large-volume commodity chemicals supplied in the hundreds or thousands of tons. The end-user base
for custom chemical synthesis also is extremely broad, ranging from virtual companies that have no
option but to rely on a third-party supplier for their molecular requirements to large integrated end
users that have their own chemical production facilities and that elect to outsource part of their
requirements. Drawing on more than 15 years of manufacturing experience, PharmaSynth scientists
have the training and expertise to ensure a successful outcome to any project. PharmaSynth also
provides necessary ancillary services that support chemical synthesis such as:
Manufacturing advice
Process validation
GMP document preparation
Regulatory advice
2.
CMC or dossier package development
Product labelling
Product distribution
Stability studies
PharmaSynth takes pride in providing a quality manufacturing service to an international standard.
PharmaSynth has a total quality assurance system developed and inspected in accordance with local
and international requirements. The PharmaSynth facility follows the international GMP guidelines as
setout in the (PIC/S) “Guide to Good Manufacturing Practice for Medicinal Products Part II (PIC/S 0098). Australia is a founding member state of the Pharmaceutical Inspection Co-operation Scheme
resulting in the guidelines being adopted by the TGA. As such our TGA licence is recognized by other
PIC/S member countries. The facility is audited routinely by the TGA and by our clients as part of their
due diligence and regulatory compliance. With these services in place, PharmaSynth offers our clients
the confidence that their product is being manufactured under the most appropriate conditions, using
the most up to date practices.
PharmaSynth is also very flexible and we can provide contract manufacturing durations ranging from a
few months to multiyear agreements. In fact, at PharmaSynth, we realise that three of the most
important issues in developing a successful commercial relationship are communication, flexibility and
trust. We pride ourselves on being client focused, involving the client as much as possible throughout
the development and manufacturing processes and in providing a flexible solution to their needs.
Contact Us
Email: enquiries@pharmasynth.com.au
Website: http://www.pharmasynth.com.au/