From Clinical Success to Commercial Readiness: Preparing Emerging Modalities for Launch

Editor’s Take: Early serialization planning helps biopharma companies avoid supply chain problems as therapies move toward commercial launch.

Moving a therapy from clinical development into commercial supply changes the demands placed on both the product and the network supporting it. Serialization, traceability and data exchange must work across manufacturers, packagers, logistics providers and other external partners, often while specialized therapies introduce their own handling and distribution requirements. For biopharma companies, preparing early can help prevent processes that worked at clinical scale from becoming obstacles at launch.

Building serialization readiness for commercial supply

By Phase III, serialization should be part of a biopharma company’s broader commercial launch planning. Sponsors need to determine how each saleable package will be uniquely identified, where serialization data will be generated and stored, and how that information will move between organizations across the supply chain.

These decisions are central to robust supply chain management and, in many markets, regulatory compliance. In the U.S., for example, the Drug Supply Chain Security Act (DSCSA) requires covered prescription drugs to be electronically traced at the package level as they move through the supply chain.¹ Biopharma companies must therefore ensure that product identifiers and transaction data remain accurate, accessible and exchangeable throughout commercial distribution.

Maintaining this level of data control can become more complex when much of a product’s supply chain is outsourced:

• A contract manufacturing organization (CMO) may manufacture the product
• A contract packaging organization may package and serialize it
• A third-party logistics provider (3PL) may store and distribute it
• Wholesalers may manage its downstream distribution

Each handoff creates dependencies around data ownership, system connectivity and decision-making authority. Maintaining control across this network requires integrated software that provides visibility into relevant data, supported by close and responsive communication with supply partners. By adopting a coordinated approach, biopharma companies can maintain control as their supply chains grow in scale and complexity.

The complexities of emerging modalities

Emerging modalities can introduce additional complexity into an already demanding commercial supply environment. Products such as antibody conjugates, DNA- and RNA-based therapeutics and peptide therapeutics can have specialized manufacturing and handling requirements that influence how they are packaged, stored and distributed. Their supply chains may also involve multiple specialist partners, increasing the number of organizations and systems involved in managing the product and its associated data.

For biopharma companies, serialization must therefore account for the specific commercial supply model of the specific therapy. Product identifiers and serialization data need to remain aligned with the physical product as it moves between manufacturing, packaging and distribution partners. As the supply network evolves, maintaining that alignment requires clear ownership of data and visibility across partner systems.

The characteristics of certain products can therefore expose weaknesses in serialization processes that may be manageable at smaller volumes but become more difficult to control at commercial scale. Addressing those complexities requires serialization to be planned as part of the wider commercial supply strategy rather than treated as a standalone packaging activity.

A commercial serialization approach

For emerging modalities, managing serialization effectively requires early planning across the commercial supply chain. Biopharma companies need to establish the systems, processes and partner responsibilities required to maintain control of serialization data as products move toward commercial launch.

1. Map the data landscape before launch

Biopharma companies should have a full grasp of the serialization data of their emerging modality by the therapeutic’s Phase III stage. This means having a clear view of where serialization data is created, where it resides, how it moves and whether it breaks down.

Achieving this visibility requires systems capable of supporting data exchange compliant with the Electronic Product Code Information Service (EPCIS), the GS1 standard that provides a common data model for capturing and sharing supply chain visibility events. In practical terms, EPCIS data describes what happened to a product, when and where the event occurred, and the relevant business context.² Biopharma sponsors need enough visibility into this exchange, via software, to confirm that partners can generate, receive and interpret the required events consistently.

The data map should extend beyond routine product movement to reverse logistics and verification. Sponsors need defined processes for handling returns and determining their disposition, alongside clear responsibility for responding to product identifier verification requests. A Verification Router Service (VRS) can route these requests and responses between supply chain partners,³ but effective verification still relies on accurate source data and clearly assigned responsibilities.

Data ownership also needs to be established from the outset. Contract packagers and other supply partners may generate commissioning or aggregation records, but ownership and access rights depend on contractual arrangements. Contracts should clearly define these responsibilities so sponsors can access the information they need to investigate discrepancies and manage returns.

2. Remove manual workarounds while volumes are still manageable

From spreadsheet searches to email exchanges, processes developed for clinical supply can become fragile when commercial volumes begin to increase and more organizations join a supply network.

This risk is amplified when a sponsor’s traceability environment must bridge partners that use different systems and operating procedures. Data accepted by one system may be rejected by another because of inconsistent master data; an interface that passes an initial connectivity test may still encounter problems when it processes data corrections.

A biopharma’s launch testing for emerging modalities should therefore follow data through complete business processes. Packaging events should be received and validated against the corresponding logistics activity. Corrections should preserve the audit trail, and both parties should understand how technical transmission issues differ from errors in the business data itself.

The aim is to establish repeatable workflows that reduce reliance on individual knowledge. Standard validation and reconciliation processes give lean teams a more dependable way to manage growing activity. Applying the same consistency to partner onboarding makes it easier to expand the network without recreating the operating model for every new relationship.

Addressing these kinds of manual dependencies early supports scalability later. It also gives the sponsor a clearer picture of which activities require human judgment and which can be governed through established workflows.

3. Design exception handling as part of the operating model

Complex supply chains can create multiple points where serialization issues may arise. These can include aggregation discrepancies, duplicate serial numbers and commissioning failures, as well as missing events, rejected files, shipment holds and returns queries. A management team’s skill at navigating these issues is determined by how quickly they can be identified and resolved.

This requires a biopharma company to establish named owners across the partner network. Teams need to know:

• Who performs first triage
• Who can inspect source data
• Who may correct or resend a record
• Who authorizes product movement
• When quality, regulatory, security or commercial leadership must be engaged.

Escalation paths, decision rights and response expectations should also be agreed before commercial launch. Management teams need to know who conducts the initial investigation and who can access the source data. The operating model should specify who may correct or resend a record, who can authorize further product movement and when additional functions need to become involved.

For lean launch teams, testing these procedures before commercialization can reveal gaps that routine readiness checks may miss. A tabletop exercise might simulate a mismatch between a shipment’s physical hierarchy and its electronic aggregation record. Another exercise could examine a request to verify a returned package or a report of missing transaction data. By working through detection, escalation and resolution, teams can clarify responsibilities, confirm access to the necessary information and address weaknesses before commercial distribution begins.

These exercises should include external partners. GS1 US implementation guidance recognizes CMOs, contract packagers, third-party logistics and reverse-logistics providers as service agents involved in serialized data exchange.⁴ An exception can therefore move across organizational boundaries as quickly as the product and its associated data. As a result, the response model needs to work across those boundaries as reliably as routine shipments do, under realistic time pressure.

4. Treat partner connectivity as a continuing discipline

Supply chain partner connectivity needs to remain effective as commercial operations evolve. Initial integration is only one stage of an ongoing process, as partners may change their digital systems, add sites or update identifiers and operating procedures. Biopharma companies may also introduce new products, increase volumes or expand into new markets. A sustainable connectivity model should accommodate these changes without requiring a bespoke integration project each time.

Maintaining reliable connectivity starts with establishing a clear understanding of each partner’s data environment. During the initial data exchange, biopharma companies should establish how identifiers and location data are managed, which EPCIS scenarios have been tested and how rejected messages are monitored. From there, change-control procedures should account for system updates and changes to partner processes to maintain reliable data exchange after launch.

This kind of partner onboarding should be measured with a durable operational record that documents:

• Contacts and escalation paths
• Systems and versions
• Identifiers and locations
• Supported transactions
• Test evidence
• Cutover criteria
• Post-launch monitoring responsibilities.

Standardizing this package reduces friction when the network expands and gives biopharma companies a clearer view of dependencies that would otherwise remain hidden.

Building beyond the first commercial shipment

The first commercial shipment of an emerging modality marks a longer period of operational change. As the biopharma sponsor introduces additional products, packaging configurations, partners and markets, its serialization and traceability model must accommodate greater complexity without requiring workflows to be rebuilt.

Decisions made before launch therefore shape how confidently the supply chain can grow. Reliable data and durable partner connections provide a foundation for increased automation, faster decision-making and more responsive operations. Companies that establish that foundation early will be better prepared to keep products moving as their commercial footprint evolves.

References

1. U.S. Food and Drug Administration, “Enhanced Drug Distribution Security at the Package Level Under the Drug Supply Chain Security Act,” January 2024 procedural revision.
2. GS1, “EPCIS & CBV,” current standard overview.
3. GS1 US, “Drug Supply Chain Security Act (DSCSA),” product-identifier verification and VRS implementation guidance.
4. GS1 US Healthcare, “Guideline Addendum: Diagrams and XML Examples for Serialized Exceptions Processing,” DSCSA Implementation Suite.

Joe Lipari is Director of Global Traceability Solutions for Systech and is responsible for the company’s global traceability and regulatory compliance solutions. His work is closely aligned with the company’s next-generation traceability platform, helping pharmaceutical organizations improve visibility, streamline exception management and maintain compliance across increasingly complex supply chains. He brings deep expertise in packaging, serialization and traceability, shaped by years of designing and deploying solutions for global pharmaceutical manufacturers. His experience spans both the life sciences and consumer goods sectors, where he has helped organizations connect operational needs with scalable technology strategies.