Clinical-Trial Material Supply by Way of Shanghai

In November 2013, Catalent Pharma Solutions opened a clinical supply facility in Shanghai, China following nine months of construction. The facility, which provides clinical supply management, comparator sourcing, primary packaging, storage, and distribution, is validated to support biologics requiring refrigerated and frozen supply- chain management. Pharmaceutical Technology discussed pharmaceutical drug development in that region with Catalent’s Leandra Mollanazar, vice-president, Quality Development & Clinical Services, and Lucy Sha, director, strategic marketing, Development & Clinical Services.

Location, locationPharmTech: From an industry perspective, what are some of the unique considerations for managing the clinical-material supply chain in China both in terms of receiving clinical-trial material supply and delivering it to the intended site?

Mollanazar: Shanghai is a strategic international port with access to all countries in Asia, including major and rapidly developing centers for clinical trials including Japan, South Korea, Taiwan, Hong Kong, Australia, and New Zealand. Catalent’s location within the Wai Gao Qiao Free Trade Zone (FTZ) will enable faster and higher quality distribution of clinical-trial materials to all China patient sites.

By considering our customers’ needs for clinical trial supply services in China and Asia, Catalent chose to locate the new clinical trial supply facility within the FTZ, which provides Catalent and its customers the flexibility to manage clinical trials under limited supervision by the customs authorities. This increased flexibility helps improve the speed of delivery and provides greater savings on duties and taxes. In addition, the FTZ location allows Catalent to employ flexible clinical-trial batch clearance through customs at the point when the materials need to be imported into China and delivered onward to clinical sites.

As an international port, Shanghai also enjoys good transportation links to all major cities and clinical sites in China, enabling appropriate, fast distribution of clinical-trial materials to patients.

Cold-chain distribution PharmTech: From an industry perspective, what specific issues have to be taken into account with respect to cold-chain management?

Sha: Catalent works with industry experts to select the most appropriate temperature-controlled packaging to meet the needs of customers and the conditions that the package will likely experience in transit. Ensuring successful distribution of cold- chain products requires extensive experience in both transportation and logistics timelines, including necessary importation and customs clearance procedures. It is of paramount importance to maintain each product’s temperature within the specified range. Therefore, there is a requirement to clearly understand the environments that the shipment will be exposed to, both during transit and in storage throughout its journey to clinic and patient. Catalent uses its significant experience and historical data taken from real cases in order to specify the most appropriate packaging and methods of transit.

Having the ability to manage the shipment globally and provide tracking and analysis of materials back to our customers is vital too. Catalent works with clients to meet any additional requirements that they stipulate.

Good supply practicesPharmTech:  A newly revised policy on Good Supply Practice for Pharma Products (GSP) was adopted by the Chinese Ministry of Health and went into effect in June 2013. Can you highlight the key issues addressed in the policy and how it impacts clinical trial material supply?

Mollanazar: The revision of GSP required that China adjust its policies for the improved supervision and control of drug distribution, especially after “drug injury events” happened in recent years.  More robust and specific qualification requirements and higher standards are the Chinese FDA’s goals to improve the handling and surveillance of pharmaceutical drug products; bringing China’s standards in line with international good distribution standards. Key changes included increased specificity of the quality management oversight, and the capability to control product quality risks at both wholesale and retail levels.

In addition, enhancements to the quality control processes specific to receiving, storage (including cold chain management), record keeping, and distribution were also implemented.

Catalent’s logistics handling of drug product and supply-chain management processes encompass global policies and procedures that satisfy the revisions to China’s GSP and help ensure global compliance, efficiencies, and cost effective mechanisms are in place globally.

The global fit PharmTech: From a company perspective, how does the new Shanghai facility fit into the company’s global clinical-trial supply business? Is it the company’s first facility in China? What other clinical-trial supply facilities does the company operate in Asia? Outside of Asia?

Sha: Catalent’s clients are expanding and investing in China and in the Asia-Pacific region. The number of clinical trials conducted in China has been growing at double-digit rates for the past three years.  Based on data from clinicaltrial.gov, clinical trials in China account for about 16% of total global trials.

Catalent’s investment in the new Shanghai facility is part of our clinical supply growth strategy. This facility expands our capability in Asia to provide our clients with more flexibility and quick turnaround time for the China region of their global clinical trials. It complements our existing facility in Singapore and our extensive Asia clinical supply depot network. It brings Catalent’s world-leading clinical supply solutions and quality standards into China, to meet our clients’ local and international needs. It is the first clinical trial supply facility in China to provide global services from primary packaging to storage and distribution.

Yes, this is the first facility in China. Catalent entered into China in March 2013 with two joint ventures, Catalent Clinical Trial Supply China and with the acquisition of Zhejiang Jiang Yuan Tang Biotechnology Co., completed in July 2013. Catalent has eight clinical-supply facilities globally. Beyond the two mentioned in Asia, we also have two facilities in the US, three in the UK, and one in Germany.