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32 BioPharm International eBook May 2021 www.biopharminternational.com cycle of a product can lead to cracks in glass vials, making plastic vials a bet- ter choice in some scenarios. Fragile packaging components can also limit packaging speed and eff i- ciency if handling requirements pre- vent the product from spinning, thus removing the option of labeling auto- mation. Biologics product that are sen- sitivity to light and temperature will further inform handling requirements, options, and limitations for not just packaging design, the types of materi- als, and production environments, but for storage and shipment, also. Biologic drugs with special pack- aging requirements demand a more complex kit design and more time to label or assemble materials. Likewise, if biologics products need to be pro- cessed in ultra-low temperature con- ditions, the choice of materials must be carefully considered. For example, adhesives behave differently based on the application temperature, the stor- age temperature and duration, and the material to which they are applied. Some adhesives will not hold in ultra- low temperature ranges; cartons may need to be mechanica lly designed. Products being processed in frozen conditions will require plastic coat- ings to streng then the car ton and protect from potential moisture dam- age. Most tamper-evident seals are not effective when applied to plastic; packaging must be adapted to ensure kits that require tamper seals remain both functional and compliant. Fina l ly, the frequenc y in which sp onsor s a nt ic ipate up d at i ng t he expir y dates for biologics products will shape supply chain and packaging approaches. Factoring this into pack- aging planning at the earliest oppor- tunity will help minimize waste. Being clear about requirements for packaging and distribution prior to finalizing packaging design will help manage risk and empower sponsors to operate optimized and f lexible supply chains that keep timelines on track. NEW CHALLENGES, NEW TOOLS To respond to the challenges presented by biologics, supply chains need to be nimble and adaptive to change. When it comes to a packaging strategy capa- ble of ensuring costly, temperature-sen- sitive products rema in v iable and f lexible for wider use across a study's lifecycle, traditional production models may not deliver in every scenario. Instead, new approaches are needed to effectively maintain control over high-cost, high-demand clinical sup- plies, while decreasing waste, increas- ing product availability, and effectively managing limited stabilit y prof iles within the clinical supply chain to meet the specific needs and timelines of biologics trials. One st rateg y sponsors ca n ut i- lize to achieve these goals and inject f lexibility and viability into biologics supply chains is just-in-time manufac- turing ( JTM). Unlike standard batch manufacturing, developed to meet the needs of lower-value, small-molecule products, and less complex program models, JTM offers a more f lexible and lower-risk option for sponsors of studies involving biologics and tar- geted therapeutics. The production strategy, which can be practiced on its own or as part of a wider LEAN manufacturing initia- tive, refers to the late-stage customi- zation of clinical kits and is becoming more prevalent across trials involving gene therapies, rare or orphan dis- eases, oncolog y, and immunother- apy treatments. It is also becoming increasingly popular for sponsors of targeted therapeutics and patient-cen- tric trials that necessitate patient-spe- cif ic labeling and kit conf iguration, for trials operating a pooled supply strategy, and for trials involving drugs with short stability and a need for fre- quent retesting. JTM makes it possible for stock materials to be packaged and labeled just prior to shipment to effectively meet varying global need, once demand is known. This approach better sup- ports variable demand typical with bio- logics programs and patient-specif ic requirements, while mitigating the risk of high-value investigational medicinal product exceeding its expiry date while awaiting distribution. Implemented appropriately, JTM can reduce the need to pre-package bulk supplies before a study commences and facilitate pooled supply across protocols. JTM can also reduce over-produc- tion leading to enhanced commer- cial performance. With a recent Tufts study estimating that almost 50% of clinical sites failing to recruit patients in line with estimates (3), significant quantities of seeding stock, produced as pa r t of a batch manu fact u r ing approach, can often remain unused and require destruction and replace- ment, due to limited expiration. By combining careful consideration of the critical factors needed to plan a robust biologics packaging strategy with adaptive production methods, sponsors can overcome the challenges of operating complex globa l tria ls of biologics and targeted therapies. Through embracing this best practice, sponsors can operate supply chains with the increased f lexibility and per- formance needed to promote timely and successful program completion, all while keeping patients at the heart of operations. REFERENCES 1. Grand View Research, Biologics Market Analysis by Source (Microbial, Mammalian), by Products (Monoclonal Antibodies, Vaccines, Recombinant Proteins, Antisense, RNAi), by Disease Category, by Manufacturing, & Segment Forecasts, 2018–2025, Report (2017). 2. Grand View Research, Precision Medicine Market Size, Share & Trends Analysis Report by Application (Genetic Tests, Esoteric Tests, Pharmaceuticals, Medical Devices), by End Use, And Segment Forecasts, 2018–2025), Report (2018). 3. Tufts University Center for the Study of Drug Development, CSDD Impact Report January/ February 2020, Report (2020). BP Partnerships for Outsourcing Operations