1. Q: Who will be the main point of contact once a project proceeds to an order?
2. Q: In what language are batch records recorded?
3. Q: How often is Asymchem audited by QA and EHS?
4. Q: Who should we contact to to arrange a visit to Asymchem's China production sites?
5. Q: Does Asymchem currently make API’s?
6. Q: Does Asymchem currently make drug products?
7. Q: Can Asymchem handle potent and cytotoxic compounds?
8. Q: How does Asymchem handle material shipping?
9. Q: What analytical support does Asymchem provide?
10. Q: How does Asymchem source Raw Materials in China?
1. Q: Who will be the main point of contact once a project proceeds to an order?
A: A technical project leader from Asymchem’s NC office will be assigned to the work, and will be the main point of contact for teleconferences, reports, process and analytical data discussions, and any other communication issues to be covered.
2. Q: In what language are batch records recorded?
A: All batch records are bilingual, written in Chinese and English. If there are any hesitations with regard to accuracy of translation, we can send the batch records off to a 3rd party for translation.
3. Q: How often is Asymchem audited by QA and EHS?
A: Typically we have about 1 QA audit a month and 1 EHS audit every 4 months. These are mainly initiated by western large pharma as well as biotechs. Asymchem has never failed an audit to date.
4. Q: Who should we contact to to arrange a visit to Asymchem’s China production sites?
A: You can call our main NC phone number (919) 468-3884, or send an email to contact@asymchem.com, which will then be forwarded to the appropriate business person. Our Tianjin headquarters in China will then coordinate and provide a detailed itinerary, book needed hotels, arrange transportation, as well as be able to provide invitation letters for your visa application.
5. Q: Does Asymchem currently make API’s?
A: Yes, we have been making custom advanced intermediates and API’s at our cGMP Kilo facility and Pilot Plant in Tianjin for several years now, and can fully release an API in-house. All production sites follow ICH Q7A guidelines.
6. Q: Does Asymchem currently make drug products?
A: Yes. We have a western standard cGMP facility for making oral dosage forms such as tablets, capsules, solution and suspension which can be used to support clinical studies conducted in the US and Europe.
7. Q: Can Asymchem handle potent and cytotoxic compounds?
A: Yes. We can handle drug product manufacturing of potent and cytotoxic compounds. Asymchem will evaluate the occupational exposure limit (OEL) of each compound. Containment and personal protection will be defined based on the OEL. Asymchem is also building dedicated facilities for synthesis of highly potent API on scale.
8. Q: How does Asymchem handle material shipping?
A: Clients can either ship the materials to our US office, which is based in North Carolina, or ship the materials to our Chinese facilities directly. The typical time for receiving materials is 5 – 7 days from the date of shipping. Similarly batches made in China can be directly exported to our clients or through the Asymchem’s US office.
9. Q: What analytical support does Asymchem provide?
A: We provide comprehensive analytical support which include method development, method validation, stability testing, release testing, spectroscopic structure confirmation and reference standard qualification.
10. Q: How does Asymchem source Raw Materials in China?
A: Asymchem has raw material back integration capabilities at our Asymchem Laboratories (Fuxin) site, which can produce upwards of 80mt material Registered Starting Materials at our current capacity. With this internal assurance of supply, Asymchem can control impurity profiles and lead-times of RM’s and RSM’s for delivery, or feed into our GMP downstream work. This site has high pressure as well as cryogenic capabilities.
Overview