May 9, 2023
Transport & Storage of Antibody Drug Conjugates (ADCs)
ADCs can be described as a new rising star among biopharmaceutics. They are able to specifically target and destroy cancer cells very effectively. Their levels of toxicity can vary depending on several factors, including their specific design and the potency of the cytotoxic drug. This is why safe handling in between facilities is such an important issue and must not be taken lightly.
Here, single-use technology - a modular, but most importantly, a closed, sterile system - can offer viable solutions. This is particularly interesting given the growing popularity of antibody-drug conjugates, because: The right solution - one that is flexible and adaptable - can help speed up processes and streamline operations.
Importance of safe storage and shipping of ADCs
With ADC manufacturing being such a complex field, most producers or CMOs are highly specialized, be it in the development and production of linkers or the final conjugation process.
As a result, potentially toxic substances are often handled through multiple stakeholder and different manufacturers, leading to supply chain challenges related to
- safe handling,
- shipping, and
- interim storage.
Shipping ADCs safely poses a significant challenge. These valuable compounds must be shielded from temperature variations during freezing storage and safeguarded against leaks at all times. Any loss of product can lead to substantial expenses and pose a risk to staff who may be exposed to hazardous substances.
Given the cytotoxicity of the substances they are handling, many CDMOs or CMOs that offer conjugation services rely on single-use technologies for processing and logistics purposes and continue to push for advances in that area. According to a report by Research and Markets, the single-use assemblies market is expected to grow from USD 10.2 billion in 2022 to almost USD 40 billion in 2023.1
Whitepaper: Ultra-cold storing
ADC manufacturing with single-use technology
Because it is such common practice for antibody, HPAPI production and final conjugation to be handled at different sites, reliable, safe and secure logistics are not only necessary but a vital part of the process. It is this very step that provides ample room for optimization, both in terms of storage and shipping.
Single-use components are ideally suited to construct closed-system supply chain solutions that can be easily adapted and integrated. At the same time, they make do with the need for sterilization and elaborate cleaning processes, concurrently leading to an increase in productivity.
It is hardly surprising that the biopharmaceutical industry is increasingly falling back on single-use technologies. Apart from offering a number of benefits such as flexibility, improved efficiency and product quality, bioconjugates manufacturing with single-use technology comes with reduced environmental impact and costs. And costs are a sensitive topic in a field where the value of a single drug dose is still exorbitantly high.
- Single-use Assemblies Market Size, Share & Trends Analysis Report by Product (Bag Assemblies, Filtration Assemblies), by Application (Filtration, Storage), by Solution (Customized, Standard), and Segment Forecasts, 2022-2030, https://www.researchandmarkets.com/reports/5665142/single-use-assemblies-market-size-share-and?utm_source=GNOM&utm_medium=PressRelease&utm_code=k9q7zs&utm_campaign=1787624+-+Global+Single-use+Assemblies+Market+Report+2022+to+2030%3a+Widespread+Adoption+Of+Single+Use+Technology+By+CMOS+Presents+Opportunities&utm_exec=jamu273prd, Published 01.09.2022