January 9, 2023
by Sanji Bhal, Director, Marketing & Communications, ACD/Labs
The pharmaceutical supply chain serves to deliver developed, manufactured drug product to patients. This is a complex system that requires organizations working together as a “well-oiled machine”. Moreover, efficient supply chain matriculation is met with a series of quality assurance (QA) and Health Authority “engagements” to ensure the delivery of consistent and safe medicines.
Emphasis by regulatory authorities on overall data integrity (security, traceability, etc.) in recent years have led to greater focus on data exchange between sponsor organizations and contract organizations. The onset of the COVID-19 pandemic further highlighted inefficiencies and gaps that prevent efficient supply chain matriculation. At the outbreak of the pandemic, there was concern that the fragmented nature of pharmaceutical supply chain would lead to shortages of chemicals, intermediates, drug substance, and drug product—ultimately leading to disruptions in the availability of medicines to patients in need.
In 2022, the pharmaceutical supply chain became an issue once again. The rebound in COVID cases, along with a surge in RSV has led to one of the worst flu seasons in many years. Antibiotics such as amoxicillin and augmentin are in short supply do to unexpected demand. Children’s medication has been especially stressed, with many over-the-counter drugs being sold out in some areas.
These factors have caused stakeholders to think carefully about how well they understand their supply chain and traceability. With a view to deliver medicines from lab to clinic in record time under the scrutiny of the whole world, sponsors and contract organizations are also motivated to improve processes and gain efficiencies wherever possible. By digitalizing the pharmaceutical supply chain, companies can remedy challenges in tracking materials and test data.
To understand how supply chain challenges can be addressed with data, software, and technology, I collected thoughts from our experts: Joe DiMartino, Luminata Solution Manager, and Andrew Anderson, Vice President of Innovation and Informatics Strategy.
Here’s what they had to say about overcoming supply chain challenges and actionable steps to increase efficiency within pharmaceutical organizations.
What are the top challenges facing the pharmaceutical supply chain?
Joe: The top challenges in the pharmaceutical supply chain today involve addressing bottlenecks within the drug development process and reducing the time of various drug assessments. Based on past trends, only 5 out of 5,000 investigational new drugs make it to clinical trials, and subsequently it takes 10 to 15 years to release a drug to market.
When a new drug product is delivered, there are multiple QA processes the development team must follow, including the ‘review and release’ step. This requires the development project team to produce extensive documentation confirming that the quality systems they used during the production phase followed specific regulatory guidance. For projects that have time-sensitive goals, like today’s current situation in delivering safe and effective medications to COVID-19 patients, this can pose a big challenge.
Andrew: To ensure that clinical trial material is of sufficient quality, traditional release review and approval operations include the preparation of quality summaries. These summaries exist as human-readable documents (which is to say, document files presented to scientists on their computer screens and visually interpreted). Subsequently, such summaries must be thoroughly examined and interpreted by expert QA staff.
The consequence of either a misinterpretation of a quality summary or an overlooked discrepancy is significant; releasing product batches that do not conform to quality specifications can have a significant impact on patient safety. Finally, the “act” of approval must usually be accounted for – albeit in record-keeping systems which are decoupled from the systems that actually support ‘review and release’ activities.
How are pharmaceutical organizations adapting to ensure a successful supply chain?
Joe: Pharmaceutical companies are looking to their digital transformation strategy as related to supply chain efficiency – and how the current pressures and demands on the industry can be addressed. Organizations can reduce the reliance on human review of data contained within documents by ’streaming‘ data from relevant sources to a digital solution used by stakeholders in an automated and secure manner. For this reason, Luminata is designed to help organizations accelerate drug process and product development through data-driven decision support and aid in regulatory filing efforts.
Andrew: We can make the QA review and release step more efficient by reducing reliance on human-prepared document-driven decision making. First, by structuring specification and test data into machine-readable formats, software could then help augment QA decision making and approval. In addition to internal QA review innovation, machine-readable structured datasets could also accelerate external party review-and-approval steps – such as those to healthcare authorities.
How does technology play a role in a successful supply chain?
Joe: Modern informatics technologies are needed to reduce both the reliance on document-driven decision making and human effort-dependent decision/approval points. Overall, stakeholders who harness advanced software and technology within their pharmaceutical development ecosystem can make better and more informed decisions based on quality data.
There are systems that currently track the chain of materials from the original manufacturing site to the sponsor company site. Luminata offers a ‘manufacturing process-to-data’ association that is missing today. The ability to view the supply chain in one place, where not just metadata is associated to a batch, but also all analytical data is associated to prevent any issues from arising.
Andrew: Digital systems (for example, LIMS, ELN, and LES) are used to capture all of the pertinent data used to prepare human readable reports to support the QA review and approval release step. I believe these digital systems can be leveraged to provide better QA support overall.
Purveyors of digital transformation and innovators within QA can support frontline colleagues by considering structural changes to how QA review and release approval is undertaken. Ultimately, we can make the entire process more efficient to bring new therapies to patients faster – whether for COVID-19 or any other disease area.
In 2022, we have seen another round of disruptions in supply chains. What role does software play in addressing these issues?
Joe: By being able to view all live analytical data within one interface, such as Luminata, pharmaceutical organizations can easily query, browse, and compare batches made internally or through contract organizations. Digital transformation reduces issues with duplicating work at differing sites and improves supply chain management. Anyone in the project team can also view which processes were used to produce a given batch in order to track genotoxic impurities.
The Future of Pharmaceutical Supply Chains
When pharmaceutical supply chain processes run smoothly and efficiently it maximizes the potential of drug development and optimizes patient safety. At ACD/Labs, we recognize this importance which is why we are committed to evolving solutions to meet customer needs within the laboratory setting. Through the digitalization of processes by means of scientific informatics systems such as Luminata, organizations will realize the benefits of easy access to organized documentation for supply chain management and the analytical data critical to CMC control development, quality assurance, and drug safety.