7 Key Considerations When Outsourcing the Manufacture of Your Proprietary Media Formulation

When scaling up biologics production, many organizations decide to outsource the production of bulk liquids and dehydrated cell culture media to a third-party provider. There are numerous advantages to outsourcing, including improved productivity and operational efficiency, reduced risk, and increased access to capacity, expertise, and facilities not available in-house or at your primary contract manufacturing organization (CMO).

While the advantages of outsourcing are clear, choosing the right supplier for your organization can be a difficult and confusing process. Your unique media formulation requires a supplier that puts your needs first, collaborating with you and providing a consistent service to drive your innovations to market. This article will outline some key points to consider when selecting a media manufacturer—from raw materials sourcing to intellectual property (IP) protection—and some of the questions you should ask early on to determine if your prospective supplier is the right fit for your organization.

INTELLECTUAL PROPERTY PROTECTION
You’ve spent a long time working on your formulation and you deserve a supplier that provides you with the utmost confidentiality and protection of this IP. Your unique formulation and any data relating to it must be held securely in closed systems regulated by strict quality assurance programs. To determine whether your IP is safe, discuss the firewalls and staff training programs in place to protect your data. Can they be audited? How do these measures protect against external threats? Choose a supplier that protects your IP.

QUALITY PROCEDURES AND MANAGEMENT SYSTEMS
ISO-certified facilities combined with robust and stringent quality management systems (QMS) that cover all stages of the process are imperative. Some of the things you should be looking out for include the separation of animal origin (AO) and animal origin-free (AOF) components, unidirectional flow of raw materials, personnel and products, and connected operating systems so any potential errors are flagged simultaneously across systems. Ask prospective suppliers to talk you through their QMS and make sure they give you the confidence that the formulation you will receive is exactly what you asked for, batch to batch and year to year. Choose a supplier that doesn’t tolerate mistakes.

RAW MATERIALS SOURCING AND CHARACTERIZATION
A supplier’s standards for raw materials sourcing and characterization should be as high as yours. Make sure you understand how raw materials are characterized and tested at their sites, and how the supplier determines whether they are fit for use. Importantly, confirm that you will be notified of any changes in product specifications. How often does the supplier complete audits on its raw materials supply and how does it monitor ongoing risk? If finished goods testing is a service that you require for your custom formulation, be sure to confirm the supplier can provide this. Choose a supplier that continuously monitors raw materials to deliver the same high quality, time and time again.

LOGISTICS AND DISTRIBUTION NETWORKS
One major challenge that biopharmaceutical organizations face when preparing custom formulations is the management of raw materials. A one-media-fits-all approach no longer suffices as our understanding of cell line requirements grows. This improved understanding has led to an increase in the complexity of formulations and the number of raw materials required to produce them. Modern cell culture media often contain 50–75 different components.¹ Maintaining the supply of these raw materials becomes increasingly complicated as the number increases. The time and financial expense associated with ordering, procuring, warehousing, and maintaining a safety stock strategy can make outsourcing the most economical and practical choice. When choosing a supplier, make sure it has a robust finished goods distribution network and can commit to assurance of supply so that you can be confident that your order will arrive on time and in full. Choose a supplier you can trust to deliver on time, every time.

SUPPLIER CAPACITY AND REDUNDANCY
Selecting a supplier with a global footprint and a robust equivalency program is very important to maintain supply continuity. You should look for a supplier with the capacity to produce your formulation in the volume and format you require. You should also understand how their capacity could be affected in crisis—be it natural disasters or global emergencies. Finding a supplier with redundancy in its key manufacturing capabilities is “mission critical” and understanding the equivalency strategies in place is key to choosing the right supplier. Choose a supplier that prioritizes consistency.

ONGOING RISK MITIGATION PROCEDURES
The bioprocessing world is not without risk, however, so it’s important that you find a supplier that does everything it can to reduce the impact of changes in supply or capacity when delivering your formulation. Make sure you’re comfortable with their emergency response, disaster recovery, and business recovery protocols. The importance of risk mitigation has been highlighted by the global crisis related to SARS-CoV-2, with the best suppliers responding promptly to change. Choose a supplier that can deliver on commitments.

SUPPLIER RELATIONSHIPS
All of these considerations, however, fail without a collaborative supplier that keeps the customer at the heart of everything it does. Choosing a supplier with a customer-centric approach is essential to help ensure your strategic, technical, and quality needs are met. Consider whether any of your colleagues/peers have worked with the supplier in the past; this is an excellent way to gauge reputation beforehand. How many team members would be assigned to your account? Is there an online account management portal that puts ordering, tracking and change notifications all in one place, simplifying your ordering experience? Your formulation is your top priority, and you should find a supplier that makes you feel that it is their top priority, too. Choose a supplier that collaborates with you to meet your needs.

CHOOSE THE RIGHT SUPPLIER FOR YOUR ORGANIZATION
You should keep all of these things in mind when choosing to outsource the manufacturing of your custom cell culture media formulation. Your formulation and process are unique to your organization. Search for a supplier that can meet your unique needs. If you require specific sourcing or process requirements, discuss them with your prospective supplier and make sure it can provide a service that suits you.

Your goals to save precious time and hit all your key commercial milestones cannot be compromised. Select the right match in a supplier relationship and your therapeutic’s journey will be dramatically advanced from process development to patient.

REFERENCE

Cell Culture Dish, Raw Material Sourcing for Cell Culture Media–Important Considerations, 2014. https://cellculturedish.com/raw-material-sourcing-for-cell-culture-media-important-considerations