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Custom Polyamino Acids FAQ

  1. Can Sigma-Aldrich manufacture custom polyamino acids?
  2. Can Sigma-Aldrich manufacture polyamino acids in large quantities (kilogram scale)?
  3. Does Sigma-Aldrich have experience in working with Pharmaceutical/Bio-pharmaceutical companies to supply custom polyamino acids for drug delivery applications?
  4. Can Sigma-Aldrich manufacture polyamino acids under cGMP?
  5. What are the capacities/capabilities for non-GMP and cGMP polyamino acids manufacturing?
  6. Does Sigma-Aldrich do cGMP stability studies for polyamino acids?
  7. Does Sigma-Aldrich have independent QA/QC departments to do method validations for polyamino acids?
  8. Can Sigma-Aldrich share polyamino acid polymer manufacturing procedures with the customers?
  9. Does Sigma-Aldrich allow customers to audit the production facility?
  10. Does Sigma-Aldrich allow customer to review batch records and manufacturing procedures during the audit?

Can Sigma-Aldrich manufacture custom polyamino acids?
Yes, Sigma-Aldrich can manufacture custom polyamino acids. Custom manufacturing guidelines under our SAFC division will apply. For inquiries, please contact your local SAFC representative or sales support staff. You may also e-mail safcglobal@sial.com for further information.

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Can Sigma-Aldrich manufacture polyamino acids in large quantities (kilogram scale)?
Sigma-Aldrich has the capability and capacity to manufacture quantities from gram scale to multi-kilogram scale with consistency and reproducibility.

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Does Sigma-Aldrich have experience in working with Pharmaceutical/Bio-pharmaceutical companies to supply custom polyamino acids for drug delivery applications?
Yes, we have supplied over 15 different Pharmaceutical/Bio-pharmaceutical companies with custom polyamino acids for drug delivery applications. Many of these are in various phases of clinical development (Phase I, II, and III).

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Can Sigma-Aldrich manufacture polyamino acids under cGMP?
Yes, we have experience in making polyamino acids under cGMP with various amino acids and ranges of molecular weights for Pharmaceutical/Bio-pharmaceutical companies.

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What are the capacities/capabilities for non-GMP and cGMP polyamino acids manufacturing?
It varies due to the nature of the process but we can easily make from gram scale to multi-kilogram scale both at non-GMP and cGMP facilities. Several multi-kilo gram scale (reactor scale) polyamino acids have been produced at our cGMP and non-GMP facilities.

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Does Sigma-Aldrich do cGMP stability studies for polyamino acids?
We perform stability studies for polyamino acids on a custom basis within our cGMP QC area, using a validated stability chamber.

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Does Sigma-Aldrich have independent QA/QC departments to do method validations for polyamino acids?
Yes, we have separate QA/QC departments and have expertise in method development and validation for polyamino acids. Method development and validation is done on a contract custom basis.

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Can Sigma-Aldrich share polyamino acid polymer manufacturing procedures with the customers?
Our manufacturing procedures are proprietary. We provide only general literature methods.

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Does Sigma-Aldrich allow customers to audit the production facility?
Yes, Sigma-Aldrich allows on-site customers audits of our quality system, facility, and processes.

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Does Sigma-Aldrich allow customer to review batch records and manufacturing procedures during the audit?
Customers who have a signed CDA (Confidentiality Disclosure Agreement) with Sigma-Aldrich can review the batch records and manufacturing procedures during the audit.

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