The Importance of Packaging Design Early in the Development Process


Cell and gene therapy technologies, the once touted technologies of the future, are presently being used to treat patients. Every month biopharmaceutical companies develop innovative treatments using gene, chimeric antigen receptor (CAR) T-cell, and stem cell technologies.1

Great excitement exists for the expected benefits of these treatments for patients. Gene therapies have been found to increase survival and, in some cases, halt disease progression.Biopharmaceutical companies are investing millions3 of dollars to develop and manufacture this new customizable “patient-centered medicine”4 as well as to upgrade their supply chains.

Although the primary focus of biopharmaceutical companies is on the development and manufacturing of the drug product (DP) and the delivery systems (e.g., syringes), packaging and labeling are key to ensuring product quality and efficacy. Packaging, labeling, and distribution of cell or gene therapy product can be as complicated, if not more, than the manufacturing of the DP itself. Many of these products require cold chain (2-8 °C) and cryogenic (-40 °C and lower) storage to maintain the integrity and efficacy of the DP during the entire supply chain.5




Consider the following scenario: 10,000 patients are scheduled to receive a gene therapy treatment for cancer. The DP needs to be shipped to the patient or the infusion center in either cold chain or cryogenic conditions. Assuming a quality acceptance level of 99.95% (meaning 0.05% of packages fail during transit due to either breakage or out-of-temperature range conditions), five patients will not get the treatment that could save their lives. Packaging technology for these therapies is thus as equally important as development and manufacturing to ensure products reach the patient.



A few of the challenges6 faced by Packaging and Labeling professionals working with gene and cell therapies are as follows:



 

3. Regulatory graphics and labeling market requirements

 


 

4. Significantly smaller batch sizes than DP made in tablets form

 



 

6. Traceability and temperature monitoring

 


 

7. Combination product requirements (e.g., 21 CFR Part 4)

 


Companies should proactively drive packaging decisions earlier in the clinical programs. Earlier development is needed to support the design of packages and labeling, not only for the clinical phase, but also for the subsequent commercialization of those therapies. Utilizing this approach integrates the knowledge of packaging and graphics professionals with commercial supply chain experience earlier in the design process. The outcome is two-fold:



  1. Optimal design aimed at protecting primary containers that will survive the challenging cold chain and cryogenic environments.
  2. Secondary packaging and labeling components that will meet the regulatory and transportation requirements.



Additionally, some of these therapies will require unique delivery systems, such as autoinjectors, prefilled syringes, and other devices. The packaging and graphics associated with these therapies will have to meet the regulatory landscape of combination products. Graphic elements, such as Instruction for Use (IFU) and medical guides that depict proper handling and use of the system, are needed to improve compliance during human factor studies. These graphic and labeling elements enable patients (or health care provides) to safely and correctly store, handle, and use the product as intended during clinical trials as well as after product launch.

Companies will benefit tremendously by partnering with the right experts in the field who can bring knowledge and validated experience to design fit-for-purpose packaging solutions. Leveraging a global network of partners can help expedite the time to market for these therapies. Some services that can be provided by partner or third-party suppliers include:



 

Secondary Packaging and Labeling Design


 

Brand Protection (e.g., Anti-Counterfeiting)


 

Serialization and Track & Trace


 

Cold Chain and Cryogenic Packaging Design


 

Transportation Testing


 

Project Management


 

Human Factors Testing and Study Support for Combination Products and Packaging


 

Smart Technologies for Temperature Tracking and Monitoring


 

Packaging Technology Commercialization and Technology Transfer to Commercial Manufacturing Organizations (CMOs)


In summary, packaging technology and engineering, graphics, and labeling design are critical components of the development and commercialization of gene and cell therapy programs. These therapies challenge us to think differently, not only about packaging, but also about how these drug products are developed and delivered to patients. Cell therapies are here now, so the industry needs to be prepared for the following:


 

Earlier collaboration between the packaging supply chain network and the biopharmaceutical industry to bring these products to the patient.


 

Creative thinking to meet the demands of cold chain and cryogenic environments to ensure product quality and efficacy is maintained throughout the supply chain.


 

Expanding packaging requirements beyond a blister, bottle, label, carton, case, or pallet to include interactive devices and sophisticated communication.


 

Development of packaging solutions to meet the needs of these innovative, cutting-edge therapies, which is critical to allow these therapies to reach all patients



Learn more about Kymanox Packaging Engineering & Technology

To receive global experience in the pharmaceutical, biotechnology, medical device, and in vitro diagnostic industries on your next project, contact the Packaging Engineering & Technology Team at Kymanox today by calling +1 919.246.4896 or sending email to [email protected].


References:

  1. Ellis M. Top 10 Gene Therapy Companies in 2019. Posted June 19, 2019. https://www.proclinical.com/blogs/2019-6/top-10-gene-therapy-companies-in-2019#
  2. Rachel Salzman, Francesca Cook, Timothy Hunt, Harry L. Malech, Philip Reilly, Betsy Foss-Campbell, and David Barrett. Addressing the Value of Gene Therapy and Enhancing Patient Access to Transformative Treatments. Molecular Therapy Vol. 26 No 12 December 2018. The American Society of Gene and Cell Therapy https://www.asgct.org/ASGCT/media/about/ValueAccessWhitePaper_MTUpdate2-8.pdf
  3. AuWerter T, Smith J, The L. Biopharma Portfolio Strategy in the Era of Cell and Gene Therapy. April 8, 2020. http://www.mckinsey.com/industries/pharmaceuticals-and-medical-products/our-insights/biopharma-portfolio-strategy-in-the-era-of-cell-and-gene-therapy?cid=eml-web
  4. The Promise of Patient-Centered Medicine. https://rxfilm.org/solutions/the-promise-of-patient-centered-medicine/
  5. Tavakoli T. Cryogenic Transport For Gene Therapy Products — Exploring The Pros And Cons. March 21, 2019. https://www.cellandgene.com/doc/cryogenic-transport-for-gene-therapy-products-exploring-the-pros-and-cons-0001
  6. Kessler P. Developing Cell Therapy Packaging And Labeling Is A Time Critical Activity. June 10, 2020. https://www.cellandgene.com/doc/developing-cell-therapy-packaging-and-labeling-is-a-time-critical-activity-0001