AUSTAR Provided Project Life-cycle Compliance Consulting Services for a Peptide Drug Manufacturer

Introduction:

Peptide drugs are short chain protein molecules composed of 2 to 50 amino acids usually, which occupy a unique pharmacology field between small molecule drugs and biological products. Since the first clinical application of insulin in 1922, peptide drugs have been developed for more than a century. In recent years, peptide drugs have attracted great attention due to their application in the treatment of metabolic diseases, especially diabetes and obesity. Moreover, with the advancement of critical technologies such as drug screening, synthesis and modification, the development efficiency and cost-effectiveness of peptide drugs have been significantly improved, and their scale-up production and application have been substantially enhanced. In this way, the bio-pharmaceutical industry has set off a wave of development and manufacturing of peptide drugs.

Client Background:

As a leading innovative drug enterprise in China, with abundant experience of more than 20 years in R&D of innovative drugs, the client has not only made remarkable achievements in the field of antiviral drugs and innovative peptide drugs, but also successfully established a long-acting peptide technology platform and a new transdermal drug delivery technology platform, at the same time, prospectively laid out a number of product pipelines. With strong technical support, the client continues to increase R&D investment, meanwhile, keeping a watchful eye on market demand, so as to scale up the manufacturing base, and accelerates the improvement of industrialization capacity.

Scope of Services:

AUSTAR has provided consulting services complying with GMP requirements during the whole life cycle of peptide drug project for the client with the assistance and cooperation of executive persons from the client and its suppliers.

• GMP design review of API & DP plants.

• C&Q preliminary consultation, such as validation master plan.

• Equipment and facilities qualification consulting and implementation.

• Process related validation, including process validation, cleaning validation, and media fill validation.

• GMP mock-up audit and training for inspection readiness.

AUSTAR Contributions and Client Benefits:

AUSTAR has fulfilled the contract on time with quality and quantity, bringing the following benefits to the client:

• The project lives up to the expectations and requirements of NMPA GMP, EU GMP, PIC/S GMP, FDA cGMP, PMDA GMP and WHO GMP.

• The plants are operated smoothly according to design specifications and functional requirements after the completion of GMP review and audit.

• The equipment and facilities are validated to be robust and reliable, with potential failures identified and production risks reduced.

• Chinese-English bilingual deliverables, professional GMP mock-up audit, and customized training for inspection readiness, which help the client successfully pass site inspections by regulatory authorities.

• The client's overall validation management level has been improved, with its quality system up to international advanced standards, and international competitiveness enhanced comprehensively.