Case Study

Successful Secondary Packaging Strategies For Commercial Launch Of A Biologic

By Shanna Stevens, Manager, Manufacturing Technologies, Packaging, Catalent Biologics

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Every biologic’s successful journey to market hinges upon the collaborative success of the sponsor company and its partners. When a sponsor company selects a commercial manufacturing and packaging partner, they entrust that partner to deliver quality products as part of their brand promise to patients. A commercial packaging solution can be the first and enduring impression that a sponsor company makes on a patient, and its suitability can impact a biologic’s commercial success.

This article describes the following aspects of a successful product launch:

  • Secondary packaging development process
  • Scope of launch preparations
  • Risk strategy
  • Milestones
  • Secondary packaging strategies:
    • Serialization
    • Artwork
    • Country requirements
    • Organizing and ordering

Secondary Packaging Development Process

During early phase technical transfer, critical attributes are defined to ensure a sponsor company obtains their desired needs for the packaging of their product. For example, a sponsor company may request an easy opening feature for patients with dexterity issues, or they may want to detect tampering at multiple levels.

Next, packaging equipment is selected and should meet the following criteria: a) provides a solution meeting the product scope identified during the technical transfer, and b) meets the requirements for the manufacturability of the product.

Continuing the process, a joint risk assessment is performed. This will typically embody a Failure Mode and Effects Analysis. In conjunction, a packaging partner would likely recommend performing engineering runs to ensure that package design features function together and process functions are designed correctly.

After completing successful engineering runs (FIGURE 1), Process Performance Qualification (PPQ) batches are performed. Although PPQ isn’t required for secondary packaging, many sponsor companies choose to perform it to ensure the process is consistent and repeatable. In many instances, PPQ batches are treated like commercial batches, similar to a practice run. If a PPQ campaign is successful, then commercial launch is achievable. Some sponsor companies also choose to make their PPQ batches with sellable product, further showing confidence in their designs, materials and processes.

Scope of Launch Preparations

Following a non-saleable PPQ campaign, sponsor companies may request further test runs, to CGMP standards, prior to the first commercial batches. These additional test runs would be used to test processes and interactions to safeguard the product’s launch strategy. Often these runs are testing processes that are outside the specific manufacturing event (such as artwork turnaround time, shipment and material release time, and document review and release time). If additional runs are requested, it is imperative that the sponsor company and packaging partner align on which processes are to be challenged then answer the following questions:

  • How many more runs are needed?
  • What is the batch run size (usually 10% of the commercial batch size)?
  • How much time between runs is needed?
  • Are there breaks built into the manufacturing process to accommodate launch strategy (i.e., labelling cartons then waiting until regulatory approval)?
  • Is there sufficient time to make changes to the batch record between runs?
  • What data must be collected to gain the confidence needed for commercial launch?
  • How many countries are targeted for launch?
  • How many stock-keeping units (SKUs) are targeted to launch per country?

Understanding how many runs are planned and how much time between runs is needed allows for documentation or processes to be revised in between runs to accommodate learnings or changes in approach. If time between runs is not incorporated, the benefit of doing additional test runs can be diminished by not refining and perfecting the launch strategy. Aligning on the launch countries and SKUs, prior to any PPQ or additional test runs, improves the launch process by focusing on what atypical attributes or features should be included.

As the sponsor company and packaging partner collaborate to answer these questions, they move toward defining the scope of their partnership, and\ create a governing document for the product’s commercial launch.

Risk Strategies

When considering risk associated with a commercial launch of a product, there are different paths available depending upon the sponsor company’s launch strategy (FIGURE 2). Broadly, a sponsor would choose from an At-Risk or Post-Approval strategy:

An At-Risk strategy allows sponsor companies to move their product to market as soon as possible following regulatory approval. A Post-Approval strategy may be used when a company determines a less urgent push to market will not directly impact the patient population. Sponsor companies may choose one of these approaches or some combination.

Milestones

Key milestones in preparing for a launch can include: artwork receipt date, batch manufacturing date, batch record disposition date, country regulatory approval date and shipping dates. It is important that the sponsor company and packaging partner define and agree on all milestone dates prior to the start of launch. As milestones and risk strategies are defined, packaging partners should engage the many vendors associated with a project. Engaging vendors early better enables their commitment to the launch timeline.

Secondary Packaging Strategies: Serialization

For some markets and products, serialization plays a key role when it is time for a product to be packaged for launch. FIGURE 3 illustrates how a packaging partner creates a new SKU for a sponsor company’s product, typically a four- to six-month process:

Serialization challenges can limit the success of the entire project. Since adding serialization measures requires a major time investment, it is imperative that sponsor companies understand the benefits of each step as early as possible, and how they play a role in the commercial launch of a product.

Secondary Packaging Strategies: Artwork

At Catalent Biologics, sponsor companies are given a primary and secondary set of item numbers for the packaging portion of their project. This forethought provides the packaging partner with a back-up strategy in order to respond quickly to potential challenges that may arise with artwork or layout.

For example, a sponsor company chose Catalent Biologics to manufacture using an At-Risk strategy. Consequently, they used a leaflet which included the month and year citing the expected FDA approval date. However, when the regulatory approval did not come within the time frame expected, the sponsor company quickly created a new artwork leaflet containing the correct month of approval. Because both parties planned for this scenario within the At-Risk approach, Catalent Biologics had already reserved additional item numbers from its supply chain team. As a result, the sponsor company and Catalent Biologics quickly processed the revision, and the print vendor reprinted the leaflet with the new artwork.

A best practice for the artwork file is to ensure all parties have the same expectations with respect to file type, size, storage and backup protocols.

Secondary Packaging Strategies: Country Requirements

Each country has unique regulatory requirements regarding medicines. When sponsor companies work with their partners on packaging efforts, these six items (FIGURE 4) should be considered when determining country specifics:

  • SECURITY FEATURES What are they? Are they added by the vendor? Are there restrictions on who knows about the features or where they are located?
  • DIE LINES How different are they from country A to country B? What are the different varnish patterns (VPs) for different countries?
  • VARIABLE DATA FORMAT What variable data format does the country require (ie. MM YYYY or MM/YYYY)? Will the sponsor company use their own lot number or will the packaging partner provide one?
  • PALLET LOAD DESIGNS What kind of pallet is required (standard U.S., European Union or specialty)? Are there racking restrictions in the distribution centers? Will product ship in temperature-controlled containers that may limit height? Will the pallet need to allow room for samples along with the shipment?
  • PRE-PRINTED VARIABLE DATA Does the equipment utilized require variable data to be pre-printed?
  • CASE LABEL TEXT Does the label need to mimic a serialization layout? Does the software system allow for special characters? Will a preprinted label be needed on which to add the variable data?

Secondary Packaging Strategies: Organizing and Ordering

Creating a material tracker spreadsheet helps ensure the materials are set up correctly and that correct quantities of materials are ordered. It also assists in identifying components that are shared between SKUs, as well as calculating how much excess material (overage) should be ordered.

In addition to calculating order quantities based on risk strategy, ordering 200-400% overage for printed or long lead time components is a normal practice depending on the risk strategy identified. This overage can be used when running the line samples or if there are equipment challenges; it can even be used for priming the line itself. Overage can also assist in mitigating timeline risks arising at any point in the process and allow for quick recovery on potential re-execution needs.

Additionally, Catalent Biologics ensures that vendors are aligned with the plan:

  • Can the vendor reserve line time?
  • Will the vendor need a purchase order early?
  • Will the vendor charge launch fees or expedite fees?

Aligning on these items before launch is one way to help adhere to launch timelines.

Conclusion

A manufacturing and packaging partner’s expertise and experience can make a significant impact on a biopharmaceutical company’s ability to get its product to market quickly and reliably. Engaging an experienced partner decreases the chance of “rookie” risks, which invariably only show themselves at critical times as the program progresses and can ultimately slow down the process of getting medicines to patients. Catalent Biologics’ secondary packaging experience includes setting up thousands of packaging materials along with the commercial launch of over 35 products into markets, worldwide.