Outsourcing Biologics: Key Considerations

Biologics are a more complex class of pharmaceuticals to manufacture, package, store and distribute than their chemical counterparts. Often with strict thermal requirements for the drug substance and drug product, specialist expertise is required to move the product through clinical phases to commercial launch and beyond.

Outsourcing of any aspect of the supply chain means that pharmaceutical companies and their chosen vendors need to work in true and complete partnership, with clear communication and navigating the complex process together to ultimately ensure speed to market. Gary Butler, Vice President and General Manager of Commercial Operations for Europe at PCI Pharma Services, explains some of the key considerations when partnering with a CDMO for the supply of biologic medicines.

How do biologics differ from other dosage forms in terms of complexity?

There are many aspects of biologics that result in a more complex supply chain than oral dosage forms. For example, thermal stability requirements mean that cold- and ultra-cold chain storage conditions are a necessity, particularly for live vaccines. Drug products stored in frozen conditions and packaged at refrigerated or ambient conditions require close monitoring. Rigorous control of “time out of refrigeration” (TOR) is required and should form part of a validated process. Other drug products may be significantly less stable than some of the older and more established biologics. Such products may be manufactured as lyophilized powders, requiring reconstitution by the end-user; this may cause challenges if the end-user is a patient rather than a healthcare professional. That said, there is a drive to use more patient-centric devices such as prefilled syringes and autoinjectors, although this does impact cost and complexity due to the unique nature of the final product. When you consider the many factors involved in the supply of biologics, it’s no surprise that logistical operations are affected as a consequence. For example, biologics require additional packaging precautions such as absorbent pads in the event of vial breakage or damage in transit. Also, during early phase clinical trials safety data may be limited, meaning that obtaining declarations and permits for transportation can pose challenges to the supply chain. Fortunately, PCI’s extensive expertise in pharmaceutical supply chain solutions is something we pride ourselves on and positions us as a strong CDMO partner.
Biologics are a more complex class of pharmaceuticals to manufacture, package, store and distribute than their chemical counterparts.

How has the COVID-19 pandemic affected the manufacture and supply of biologics?

Unsurprisingly, the pandemic has created many challenges within the pharmaceutical industry. Accelerated vaccine programs have consumed a lot of capacity in both drug discovery organizations and their CDMO partners, a situation which has been compounded by the increased demand for raw materials, consumables and analytical materials. PCI, as a global CDMO, had to react quickly. We changed our standard business model to secure the supply of raw materials and store inventory on behalf of clients. If the pandemic has taught us anything, it’s that every business in the supply chain is essential, irrespective of where they sit. Temperature-controlled shipping boxes are also in short supply, resulting in longer lead times and therefore longer-term, proactive procurement strategies. This shortage is due to multiple factors, not least of which being the increased demand in line with the general growth in the biologics market. Many patients also now receive medications directly, resulting in shipping container manufacturers themselves experiencing their own supply chain challenges. The pandemic also impacted the frequency of commercial flights, meaning that PCI began using standard courier cargo flights to move products on behalf of our clients.

What strategies can be employed to mitigate risk and delays during the drug development and commercialization journey?

The early evaluation of stability data can be advantageous, however, many companies don’t generate this type of data early on; in some cases, it may not have been considered or deemed too costly at the early stages. By initiating stability studies early on, it can save time and money later on and mitigate issues that may arise during shipments, such as stability, freeze/thaw and temperature range excursions. Testing with multiple excipients can also reduce uncertainty and risk during the product life cycle. The pandemic has taught us to find more efficient ways of working, expediting timelines and reducing bureaucracy, meaning lifesaving medicines are more accessible to patients.

So how can you ensure a successful collaboration when outsourcing the packaging of the biologics?

In our experience, there are three main aspects to a successful partnership between the sponsor company and their vendors. Working with one partner for the life cycle of the product is one such aspect, ensuring an understanding of the product and maintaining the knowledge and experience needed. Moving between CDMOs is not a straightforward task and so working together to deliver an end-to-end solution and navigate challenges along the way leads to success. The process by which a third party is chosen and the assessment criteria is also critical. This should not only take into account the CDMO’s technical capabilities, but also some of the more subjective factors such as how the company communicates, how they approach a problem, their proactivity and the emphasis placed on building a true partnership, whereby the vendor becomes a seamless extension of the sponsor team. The team at PCI, from Project Managers through to line operators, are all highly experienced and trained to be an extension of the client team, offering the best partnership possible. The third aspect and one that PCI feels is crucial to long-term success, is to continually educate employees about the nature of the actual drug product itself. This drives care and ownership to a different level; rather than employees feeling they are simply filling a vial, employees truly understand the impact of what they are doing in human terms, i.e. improving or even saving lives. We’re in no doubt that this promotes a feeling of really making a difference and taking pride in what we do.

Outsourcing Biologics: Key Considerations by Gary Butler
As published in European Pharmaceutical Manufacturer Magazine

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