What is PharmaSynth's area of expertise?

PharmaSynth is able to manufacture most types of APIs, however our specialty is considered to be production of biopharmaceuticals from bacterial or yeast origin. This combines with the synthetic chemistry skills we have developed to result in a unique set of core skills.

How can PharmaSynth work with client timelines?

Unfortunately one of the realities of pharmaceutical development is that decisions on manufacturing are often left to the last minute. PharmaSynth's flexible approach to scheduling manufacturing means that we can often accommodate short notice manufacturing requirements. We have developed this approach in response to the past requirements of many of our customers.

Does PharmaSynth provide quality assurance?

Yes, PharmaSynth through its parent company Progen Pharmaceuticals has held a GMP manufacturing licence for more than 15 years. During this period, our quality systems have developed alongside the development of cGMPs and the implementation of harmonised guidelines. Our Quality group also has experience in preparation of CMC documents to support phase 1, 2 and 3 clinical trials performed in Australia, the US, the UK and Taiwan as well as a range of other countries. Our quality systems ensure that products are not released for use unless they have met stringent GMP requirements.

What is the typical chain of events when working with PharmaSynth?

1. Initial enquiry for manufacture of a product
2. Evaluation of project by PharmaSynth for fit with facilities and core skills
3. Implementation of a non disclosure agreement
4. Submission by the client of a request for proposal outlining manufacturing requirements
5. Submission of detailed manufacturing information by client and discussion of timelines
6. Preparation of detailed quotation by PharmaSynth and submission for client review
7. On acceptance of quote, preparation of manufacturing contract by PharmaSynth for review by client
8. Signing of contract and GMP agreement
9. Tech transfer of manufacturing process into PharmaSynth by client
10. Process development / trial runs as specified in contract
11. Preparation of GMP batch manufacturing records and set up of raw material and QC quality systems
12. Approval of documents by client
13. Sourcing of GMP raw materials
14. GMP manufacture
15. QA review of completed manufacturing documents
16. Client review of manufacturing documents
17. Release of product