PR: Biocair looks to the future of drug development and distribution with a new process for risk mitigation in supply chains

To support the increasing complexity of cold chain logistics, Biocair has announced a seven-step process to mitigate the risk posed to goods in transit.

The global specialist in temperature-controlled logistics for life sciences has introduced the procedures to ensure contract manufacturing organizations (CMOs) and contract development manufacturing organizations (CDMOs) are able to have confidence and visibility in the transportation of active pharmaceutical ingredients (APIs) and finished drug products.

This is in response to the increasing complexity of cold chain logistics resulting from personalized medicines coming to market, research trials becoming more global and supply chain disruptions caused by unexpected events having a lasting effect.

CMOs and CDMOs play a significant role in every stage of the drug development process, and because of market requirements, are producing and handling more temperature-sensitive materials. While specializing in specific processes and materials, the area of risk mitigation across the entire supply chain is increasingly complex, with recent world events highlighting the repercussions of major disruption for manufacturers, and particularly for those whose products contain APIs.

Managing risk for these organizations across the supply chain has been addressed by Biocair thanks to its award-winning insights into global logistics paired with local, in-country expertise. In addition to having a robust understanding of the climate and infrastructure that affect key shipping lanes, Biocair holds extensive knowledge of domestic and international regulations. 

It has created a seven-step process to reduce supply chain risk when shipping APIs and finished drug products. To manage and mitigate risks across complex life science supply chains, Biocair states that CMOs and CDMOs should take the following steps:

1. Collaborate with a specialist third-party logistics partner to identify risks across the supply chain to gain all-round knowledge
2. Factor in time for a full risk assessment for the complete supply chain from manufacturer to customer
3. Work with the logistics partner to gain a detailed understanding of the specific risks and challenges
4. Ensure risks are assessed at every stage of the shipment’s journey
5. Create a job-specific lane risk assessment that adheres to all regional regulatory guidance
6. Complete customs and compliance paperwork in advance
7. Understand and adhere to the latest regional duty and tax liabilities

Step one: Collaborate to gain comprehensive knowledge

Within the life sciences sector, supply chains for medicines and products that contain APIs are most often global. Biocair’s added knowledge of regional variations in transportation, climatic conditions, regulations and standards delivers an in-depth understanding of the complexities for manufacturers and customers. Input in the early stages can help mitigate risk and supply chain disruption, ensuring products arrive to customers safely, securely and on-time. Collaboration at this stage between the manufacturer, sponsor and specialist logistics provider is key. 

Step two: Factor in time for a third-party risk assessment

The life sciences sector can be subject to rapid changes, meaning that risk assessments for one lane are unlikely to be fit for purpose with a new product or geography or a change in sponsor requirements. Biocair can map the whole supply chain to assess what it should look like per product, and ensure sufficient time is built in to manage any variations.

Step three: Understand the specific risks and challenges

Tailored shipping and routing requirements can be challenging for CMOs and CDMOs due to the differing needs of each shipment. Fully tailored and flexible contingency plans should be in place to mitigate potential risks.

Step four: Ensure risk is assessed at every stage

Both the Food and Drug Administration (FDA) and the Medicines and Healthcare Products Regulatory Agency (MHRA) require supply routes to be mapped and risks assessed at each step. Therefore, a key requirement is that logistics providers adhere to GDPs at all times – and in all regions – transparently and with confidence.

Step five: Create a job-specific lane assessment

The various global regulators have set standards to ensure medicines are transported with product and patient safety prioritized. When shipping APIs and finished drug products, CMOs and CDMOs need to understand and adhere to all regional regulatory guidance across the supply chain. This will require a comprehensive risk assessment which takes into account every point in the shipment’s lifecycle and develop risk mitigation procedures for before and during transport.

Step six: Complete all customs and compliance paperwork in advance

To prevent shipments being held by customs, it's important that paperwork is correct and complete. Delays can result in lifesaving medicines not being delivered in a timely manner and can even result in medicines becoming non-viable. To avoid this, Biocair recommends that medicines should only be shipped when all the necessary regulatory and compliance paperwork is completed and checked in advance.

Step seven: Understand regional tax duty and tax liabilities

Tax liabilities regarding the import and export of medicines varies around the world. A specialist logistics provider with a global network, such as Biocair, can outline the duty and VAT requirements of shipping pharmaceutical products to different regions.

Sarah Pentney, Biocair’s Head of Quality & Compliance, comments: “Our knowledge in specialist logistics means that we partner with CMOs and CDMOs to become familiar with global transport regulations and standards. This methodology means we can help deliver lifesaving and life changing therapies seamlessly, on time and to the highest standards. We will identify all possible risks and create tailored solutions to mitigate potential disruption and issues, all of which is detailed in the seven-step process.”

There are a number of questions that need to be asked at each stage of the journey and layers of detail that should be considered.

About Biocair 

Since 1986, Biocair has established a global reputation as a leading GDP logistics specialist within the pharmaceutical, biotechnology and life sciences sectors. Biocair has built up a unique, client-centric approach by employing scientists in front-line logistics positions and assembling a team of best-in-class industry experts in quality, cold chain and regulatory compliance. Biocair focuses on providing the most comprehensive time-sensitive and temperature-controlled logistics services available whilst delivering flexible, tailored, cost-effective solutions to all its clients. It is committed to delivering complete end-to-end logistics solutions through its 24/7 operation and global network spanning across Europe, Africa, Asia and the Americas. 

Biocair employs over 550 people worldwide and provides specialist logistics services to more than 160 countries through a global network of partners. Biocair’s offices are located in the UK, France, Belgium, Germany, USA, South Africa, China, Singapore and India.  

In 2012 Biocair was acquired as an autonomous division by Geopost. Geopost is the largest parcel delivery network in Europe, which posted sales of €15.6 billion in 2022. Geopost is a holding company owned by Groupe La Poste.