Logistical Challenges in the Field of Sterile Injectables for Clinical Trials

Sterile injectable drugs have ushered in a new era of targeted vaccines, as well as gene and cell therapies, which have been called the “third pillar” of modern health care.

by Raymond E Peck, CEO of VxP Pharma

Injectables are highly susceptible to damage from temperature fluctuations, poor handling, and even improper packaging. Since many injectables are toxic in their natural forms, these hazards present very real risks for manufacturers, clinics and patients alike.

It’s more crucial than ever for pharmaceutical development firms and contract manufacturing organizations (CMOs) to coordinate their logistical strategies. The more reliably these organizations can ensure compliance with regulatory standards, the more effectively they’ll be able to deliver a steady global supply of sterile injectables for clinical trials.

Here are three of the most significant trends currently shaping the sterile injectables field.

Clinical trials of sterile injectables require carefully coordinated logistics.

Clinical trials of sterile injectables frequently involve complex transport chains for patient samples, biomarkers, and the injectables themselves.

Clinical trials of sterile injectables frequently involve complex transport chains for patient samples, biomarkers, and the injectables themselves. Each of these components may need to be maintained at a different temperature during transport, and many need to be moved from origin to destination in a matter of days or even hours.

Further adding to the complexity is the fact that many injectable therapies are personalized for specific patients. This means they must be shipped with individual ID tags, all of which must be secured in order to ensure compliance with HIPAA, or its equivalent in the country where the trial is being conducted.

Thus, a clinical trial’s success or failure hinges not only on the effectiveness of the injectable itself, but also on precise storage, packaging, handling and transport of all other components. A single misstep in regard to temperature or time delay can result in significant loss of trial data, and may even compromise the legitimacy of the trial as a whole.

But the physical handling of trial materials only represents a fraction of the logistical challenges involved. Still more hurdles are added by the regulatory criteria around the manufacture, storage and distribution of injectable therapies.

Stringent regulations create further logistical complexities for sterile injectables.

The EXCiPACT Certification Scheme for Pharma Excipients (in the US) and the Eudralex guidelines (in Europe) both already mandate good manufacturing practice (GMP) and good development practice (GDP) guidelines for the marketing authorization holder (MAH) of any pharmaceutical product.

Any organization that manufactures a sterile injectable must maintain sterile facilities, perform active monitoring, ensure adequate air handling, and meet a long list of other requirements, in order to be permitted to distribute its products internationally. Organizations that fail to comply risk having their therapies banned, or tagged with warning labels, at the very least.

In addition to these existing regulations, groups like the International Organization for Standardization (ISO) are also planning to adopt the ISO /TC 212 and ISO/TC 276 standards for the storage and distribution of therapies, once the products have been manufactured. These standards will further restrict the duration of transport for any therapy, biomarker or sample in a clinical trial. Packaging will also be held to higher standards, in terms of tracking and validation.

Automation and informatics may offer hope of greater efficiencies in the sterile injectables sector.

Automation and informatics may offer hope of greater efficiencies in the sterile injectables sector.

Developers and manufacturers of sterile injectables are already responding to these growing logistical hurdles. An increasing number of CMOs are incorporating logistical support into their operations. Pharma firms, meanwhile, are conducting research on the duration, temperature and stability of their products, much earlier in the development cycle.

The field of informatics offers a range of technological solutions that may prove crucial for sterile injectable trials over the next several years. The latest software platforms can track and overlay data on manufacturing, distribution, storage, patient enrollment, clinical scheduling, and reimbursement, so planners can actively work to prevent losses due to scheduling errors, missed flights, or lack of therapy support at a given location.

These software platforms also provide the ability to collect and analyze data on a per-patient basis, tracking the trial process from enrollment all the way through chain of condition and eventual reimbursement. Given the complexity of supply chains for clinical trials of sterile injectables, this degree of optics will often prove to make all the difference between the success and failure of a project.

As the regulations and requirements around sterile injectables grow more complex and stringent, close cooperation between pharma developers and CMOs continues to become ever more essential for the success of a clinical trial. A clear understanding of the necessary packaging, transport, labeling and temperature conditions is now vital from the early stages of development.

With the help of informatic systems and automated data-gathering platforms, trial managers are gaining more of the tools they need to anticipate and prevent damage to products, biomarkers and samples. Increased adoption of these tools will bring greater stability to injectable trials, and help ensure a steady supply of therapies around the world.

In addition to being a writer and speaker, Raymond E Peck is the Founder and CEO of VxP Pharma Services and VxP Biologics, both based in Indianapolis Indiana.