Packaging of Biologics and Specialty Medicines: Planning for a Seamless Transition from Clinic to Launch.

The pharmaceutical landscape continues to evolve with an ever-increasing focus on specialty medicines.

As a result, supply chains are becoming more complex, driven by factors such as cold and ultra-cold chain requirements, the growing complexity of delivery systems, and the ever more stringent regulatory requirements associated with the packaging of such products.

A stronger focus during the clinical stages of development on longer-term commercial packaging considerations may lead to both cost and time efficiencies in terms of commercialization. Partnering with a single vendor that has experience across the entire clinical-to-commercial spectrum may offer far more value and speed to market than working with different vendors throughout the cycle.

The ongoing global pandemic has taught us that expert packaging partners have been able to help pharmaceutical companies to deliver time-critical supplies from early clinical phases to commercial launch, often with specialist cold-chain and ultra-cold chain requirements. The industry has seen expert partners working with their clients to launch vaccines in less than 12 months from development inception.

There are some important underlying principles within this process that may reduce both potential risks and associated costs. These include planning for commercial launch early in the development cycle and working with a partner with specialist packaging design capabilities, expertise, and experience across the development-to-commercial launch cycle.

Is There an Opportunity to Expedite Launch Whilst Reducing Costs and Risk?

Historically, teams within companies have tended to focus only on the current development phase of a given product. Internal departmental structures and budget flows may have been the driving force behind this approach, with early-stage R&D teams operating relatively separately to their later-stage commercial launch counterparts.

However, it is becoming increasingly clear that taking a more holistic approach, breaking the silos, and managing the cycle as one seamless process from development to launch may offer many benefits. For example, planning for your commercial launch requirements earlier within the clinical development cycle may reduce risk-to-launch timelines and therefore avoid unnecessary delays. Early consideration of commercial launch dates may also offer the opportunity to expedite the process, reduce costs and improve the patient experience compared with a more traditional model.

Complexity Is Increasing: What Does That Mean?

A number of factors are driving increased complexity. The growth in biologics and immunology drugs is associated with more complex product delivery. This in turn has regulatory implications, which can be better managed by working with partners with experience of clinical through to commercial packaging regulatory needs.

The increasing requirement of cold-chain and ultra-cold chain transportation adds further complexity, as does the constantly evolving area of actual drug delivery systems. The increased use of patient self-administration with autoinjectors and prefilled syringes creates a need for more sophisticated packaging requirements. All such variables lead to an ever-evolving level of sophistication in packaging requirements and, in some instances, a need for bespoke packaging solutions to accommodate additional devices within one patient kit. As such, the extent of commercial packaging considerations for new innovative drugs has increased.

Broadly speaking, when dealing with non-oral combination products, there is an exponential increase in complexity, with companies having to evaluate how sterilization procedures work with the packaging of products given via an injection or implant delivery form. The team may have been successful when optimizing the sterilization method for the drug product; yet, they may not have considered the impact of the packaging and the packaging process … and therefore the packaging design requirements.

There is also the added complication of human factors and an increased focus on patient adherence. Historically, delivery forms such as inhalers were subject to testing with regard to human factors in terms of how the patient administers the product; however, such requirements are now starting to creep into injectables — with the US FDA expecting companies to demonstrate clear thinking with regards to human factors. This has led to a stepwise change in terms of packaging development and design needs.

It is also worth noting that for those products that are on a fast track process or designated as a breakthrough therapy, the clinical development process is hugely accelerated — meaning that CMC development may become a rate-limiting factor in terms of submission. In such instances, early decision-making related to CMC is critical in terms of delivering the fastest possible launch timelines.

What Are the Benefits of Working With a Specialist and Experienced Partner?

There are many reasons why a company will choose to work with an external vendor. Irrespective of company size, the reasons are usually similar (with size perhaps just affecting the scale). It may be because of internal capacity constraints or capabilities, particularly when entering new markets in which, perhaps, the specialist capabilities needed simply do not exist. Smaller companies may have a total reliance on external vendors, whereas larger ones may have a specific challenge that requires a partner.

Irrespective of the reason, there is one overarching requirement that is of critical importance: any packaging partner must be familiar with the actual manufacturing and packaging technologies because of the impact these may have on the packaging process itself. Therefore, utilising a standalone packaging design partner that’s not intimately involved with the manufacturing or packaging process may ultimately lead to oversights, increased costs and prolonged timelines.

Is Partnering With One Vendor From Development to Launch a Good Idea?

If a packaging vendor has the capabilities throughout the development-to-launch cycle, it can be far simpler and beneficial compared with using one partner for the clinical phases and then changing to another for the commercial launch. This is because a vendor with experience in all aspects of the cycle may offer a more seamless transition between the stages, using knowledge gained at each stage to inform the next, as well as ensuring a focus on the commercial launch early in the development process. This may be especially beneficial when a global partner with an international presence is well versed in the technical and regulatory requirements of a global, multi-SKU launch programme.

There may be a need to focus on a multiregional strategy for packaging, allowing for the unique requirements of individual markets. This is especially true in the EU where there are differing mandates relating to serialization, Braille, and child-resistant packaging, to name but a few. In the US, there are also differing needs between states with regard to the use of tamper-evident seals; therefore, engaging with a vendor who both understands regional differences and is able to navigate the associated packaging requirements would offer a clear advantage.

Put simply, working with a specialist partner that’s able to demonstrate a synergistic relationship between the clinical and commercial divisions, and operates from a central set of design standards, may drive efficiencies, result in innovation, minimize risk and deliver time and cost efficiencies.

How Should Clinical and Commercial Teams Work Together?

There are historical anecdotes concerning the hand-off between clinical and commercial teams being more akin to a relay race; and, although there is an element of teamwork, once one team has completed their “leg,” there is little further interaction or planned onward teamworking.

A more forward-thinking approach would be for teams to break out of the silos dictated by phase and apply a more holistic approach throughout the development-to-launch cycle. Best practice would see the clinical and commercial teams engaging at a far earlier stage of the development cycle that continues through and past the actual commercial launch. By partnering with a vendor who applies this philosophy internally, working in partnership ultimately drives this same approach within the client company.

This becomes critical when the parent company is based in one geographic location and has led clinical development, holds the NDA — basing regulatory requirements on that particular geography — and then passes the commercial launch responsibilities elsewhere. In this situation, a careful plan is required to consider all aspects of the commercial launch. Partnering with a vendor that’s able to navigate this at an earlier stage, and is able to anticipate global requirements, could be seen as beneficial.

In a large pharmaceutical company, the clinical team may not even know who the commercial team is and vice versa. At small companies, people wear multiple hats and may be in both camps. If we’re doing our part well with strong project management, we prompt them to engage in dialogue and reach some of the decision points quicker.

So How Has the COVID-19 Pandemic Changed Things?

The COVID-19 pandemic has and continues to touch almost every aspect of life … and pharmaceutical development is no exception. We have seen vaccines being developed and made available for commercial use in a timescale that would have been almost unthinkable prior to the pandemic. The pharmaceutical industry rose to the challenge in a truly heroic manner and worked with regulatory authorities to expedite approval timelines in an unprecedented way.

It is clear that the pandemic has affected all levels of pharmaceutical distribution. In terms of the clinical phases of development, with patients and their carers unable to attend a clinical site, site-to-patient and direct-to-patient distribution are being explored as viable options — as is the concept of decentralized clinical trials. At one time deemed to be a purely theoretical notion, they are now being considered as essential alternatives.

The pandemic brought additional complications to the process; with countries on lockdown and travel not allowed, regulatory audits all but stopped. As ever, the industry in which we work was quick to respond, using technology and innovative processes to provide virtual audit platforms to ensure ongoing regulatory compliance. As we move through the next stage of the pandemic and the world begins to open up once more, there is a question regarding the need for 100% onsite audits (especially in the CDMO arena in which the standard audit process has proven to be successful when run remotely on a virtual platform). Therefore, questions are now being asked about the criteria for an onsite audit versus using a virtual platform and how to achieve the aims of an audit when working with vendors with this experience.

What to Consider When Looking for a Packaging Partner?

There are many standard aspects that all companies will look for, such as regulatory excellence, global reach, track record, previous experience, capability and capacity, to name but a few. However, experience tells us that there are some other factors that should also be considered.

A significant criterion is the availability of in-house packaging design and the ability to create prototypes of clinical and commercial packaging during the development process. The US FDA is placing increased focus on how companies present their drug packaging — asking in advance to see the proposed commercial launch packaging. Therefore, choosing a partner with expert packaging design and prototype development capabilities would be advantageous.

Another may be an assessment of the vendor’s global reach and true experience, particularly in the area of specialist medicines. It is clearly beneficial to partner with a vendor that has and is working with multiple companies at a global level. This is important because that breadth of expertise and experience can be applied and shared, often adding a different perspective or a variety of options. This can only come from a vendor with a certain level of experience.

Finally, there’s organisational culture. Considerations include the potential partner’s quality culture, their framework regarding how they work with their clients, the ability to provide flexibility and adaptability, established SOPs for ways of working, governance, KPIs and review metric criteria. A truly collaborative relationship between both parties is essential and that becomes of paramount importance when reacting to a bump in the road or an unexpected event.

Such obstacles are more easily overcome when a truly joint effort is made to deliver the fastest and most effective solution. Clients who can offer focused attention to a particular client’s needs, and solve them, can make a critical difference. Careful partner selection can avoid the unhelpful spiral into the blame game, a regimented bureaucracy or contractual arguments that do not serve to meet the goals of the clinical project and ultimate success of commercial launch.

In Summary

It would seem advantageous to partner with one vendor from early stage development to commercial launch whenever possible, whereby the vendor has the capabilities required to deliver the best possible service at each stage. It would seem sensible that planning for commercial packaging at the earlier stages of development may lead to both cost and time efficiency gains when considering the full development-to-commercialization cycle. It is important to identify a partner that’s not only well versed in this approach but one that’s able to offer packaging design services with prototype development options as part of the process.

In addition, global reach and capabilities specific to specialty medicines such as cold-chain packaging would also be key criteria on which to base an outsourcing decision. One thing is clear, the growth in specialty medicines is not going to slow down anytime soon and outsourcing partners have invested in the infrastructure and technologies needed to service the growing market demand.

Biologics and Specialty Medicines: Planning Your Packaging for a Seamless Transition from Clinic to Launch. – seen in Manufacturing Chemist August 2021

We provide a complete range of commercial packaging services and we are committed to supporting clients at every stage of the clinical cycle, delivering best-in-class services efficiently and effectively.

Find out more about our Packaging of Biologics capabilities.

Our dedicated team of specialists will be happy to discuss any of your packaging of biologics needs. Contact us on +1 779-208-1819 (US) or +44 1495 711 222 (UK/EU) or email