The manufacturing process is becoming even more complex, and drug inventories are increasingly high value. Meanwhile, demand for APIs and drugs with tighter temperature control is growing. The market has evolved, with increased complexity due to border regulations, time and temperature sensitivities, and the volume of suppliers and CMOs.

By working with a single provider, organizations can secure an unbroken chain of custody with visibility across every stage of global supply chains. An end-to-end service provides tailored supply chain solutions for specific and complex requirements, flexibility and agility to respond to last-minute variations, and robust risk management to ensure supply chain consistency.

Remapped Ways of Working and Supply Chain Consistency
 
The varying temperature requirements throughout the process for APIs compared with the final product need to be maintained during inter-company transport and between CMOs. 

As molecules become more complex, supply chains can include multiple suppliers all required to deliver their products within detailed specifications. With portfolios increasingly more specialist with shorter shelf-lives and stricter temperature requirements, the traditional siloed model no longer works. An all-encompassing solution including packaging, pre-positioning, pre-conditioning, and end-to-end logistics is essential. 

Packaging solutions now must cater to specific drugs that require -40°C or -50°C for transport and storage, and for APIs with a shelf life of just 48-72 hours. Opting for traditional box solutions, which are less agile, will impact meeting today’s requirements. 

The Benefits of an End-to-End Solution

By tapping into an integrated solution for supply chain logistics you benefit from: 

      1.  Agility and Flexibility 

An end-to-end approach ideally caters for short term storage of APIs, API-intermediates, drug substances, and drug intermediates. Crucially it enables the storage of both small quantities and bulk quantities to bridge the time ahead of a scheduled manufacturing slot: 

      -  From the R&D stage to a CMO for either clinical or full-scale production of the API
      -  During technology transfer, while switching from one CMO to another 
      -  To overcome capacity constraints 
      -  For storage of retention samples 
      -  For storage of impurity standards
      -  For storage of samples for QC release/testing

If for instance, an organization’s manufacturing is taking place in India, materials can be stored and transported between CMOs there. If any issues occur and the location needs to be changed, to Singapore for example, materials can be transported and stored there with little impact on continuity. In an ongoing age of uncertainty, robust and flexible business continuity planning is vital. 

      2.  Data for Tracking and Auditing 

Data is fundamental and it continues to play an increasingly important role to ensure end-to-end supply chain visibility. Ongoing access to data, whether through feeds, reporting or system integrations can help you define where disruptions are taking place and forecast where they may occur. 

It is also key both for temperature-controlled packages that can’t be manipulated and to counter the continuing counterfeit and black-market threat. 

      3.  Import Solutions: Free/Foreign Trade Zones 

Access to Free/Foreign Trade Zones (FTZs) offers the essential agility and speed to market. By being able to access FTZs you can guarantee the quality of the API, negate any temperature excursions and keep your importation costs as efficient as possible.

World Courier’s Approach 

By working with World Courier, you can access temperature control solutions, storage, and transport across a tailored supply chain model. We work alongside you to understand your requirements and define your data needs. 

Whether enhanced visibility of the locations of starter materials or temperature tracking. By adopting a range of different technologies, we build our solution around your key specifications.

Our end-to-end service unites all components of the drug supply chain. This includes small volume products independent of storage length. And our expertise in clinical trial logistics guarantees this detailed experience can be transferred to tackle the increasing complexity in the manufacturing process. 

To find out more about World Courier’s approach to business continuity and risk mitigation within specialty drug supply chains, please get in touch. 

Maintaining Chain of Custody with Last-Minute Storage Solutions 

World Courier was approached to deliver 103 bottles of large molecule APIs that would be the basis for manufacturing a new drug designed to treat rheumatoid arthritis in adults when the response to anti-rheumatic drugs has been ineffective. 

Due to the importance of finding critical links in the supply chain between the production of raw materials and manufacturing sites, a tailored solution was required for the APIs.

Originally intended for arrival in the manufacturer’s depot, our customer decided to store the shipment at a World Courier facility in a last-minute change to maintain the chain of custody of the APIs. In response, World Courier developed an individual SOP for the storage of the high-value APIs in our facility in India. Meanwhile, we built a custom made refrigeration facility designed to maintain the integrity of APIs.

To execute the supply chain process successfully, World Courier shipped the APIs using our GTC 125L packaging, across three destinations, at the following temperature ranges: 

      -  -60°C for the APIs from Europe to India 
      -  +2°C to +8°C to transport of semi-finished products from India which were stored for two
          months
      -  +2°C to +8°C of the finished products to the US and Europe

Everything was stored and delivered safely, on-spec and on time.