There are multiple approaches to gaining a foothold within the bioprocessing industry, but small firms sometimes overlook how capturing the attention of a large firm early in their product development process may pay off in the future.
How does a small biologics supplier find new business with a large client? Start small.
At MKA Insights, we’ve advised multiple firms on how to gain a foothold in a very competitive, highly regulated industry.
Understand Process Development
In the process development stage, biologics manufacturers identify the equipment, raw materials, and supplies they can use to manufacture their target of interest, such as a therapy. They make decisions on the raw materials and manufacturing solutions such as which single-use film to use. This is long before any product is available to the public, and solutions will likely go through multiple iterations.
This step takes a long time, given that this is when manufacturers test whether their solutions scale up reliably.
This step provides an opportunity for suppliers to establish and strengthen relationships with their clients. Decisions made at this stage can have an impact, especially if a manufacturer decides that a particular supplier offers the best product for their needs. Sometimes, manufacturers may even choose to partner with smaller firms in order to design products tailored to their needs.
When a manufacturer is ready to transition from process development to large-scale production, they lock in their chosen suppliers to scale up alongside them. It is therefore crucial for suppliers to understand the needs of their customers and to ensure that the solutions they offer meet the long-term demands.
Meet Industry Standards
Biologics manufacturers face strict regulation and must hold themselves accountable for the safety, efficacy, control, and quality of their products. Therefore, the manufacturers must apply the same strict standards to every supplier they engage. The procurement stage often involves quantifying risks to products as well as making sure their suppliers conform to industry standards.
There are multiple industry standards which are widely accepted and followed by biologics manufacturers. It is expected that suppliers will also adhere to these same standards.
Some of the relevant bodies include ASME-BPE, ASQ, BPOG, BPSA, ELSIE, FDA, ICH, ISPE, PQRI.
For example, the BioPhorum Operations Group (“BPOG”) is a global consortium of biopharmaceutical developers, suppliers, and manufacturers. The group has established standards for single-use capital equipment and supply purchasing, which the industry widely accepts and includes in most requests for information and proposals for capital equipment sales.
ASTM International, formerly known as the American Society for Testing and Materials, develops and publishes technical standards for a wide range of materials, products, systems, and services. They have set standards and technical specifications for a range of products, including film thickness (D-374) and refractive index (D-542).
Publicly available data can help suppliers with design, engineering, testing and release of equipment and supplies for bioprocessing applications. Standards include ICH Q6B (test procedures and acceptance criteria for biotechnological/biological products) and ISO 8570:1991 (plastics film and sheeting, determination of cold crack sheeting).
Understanding the industry’s level of regulatory scrutiny is necessary for suppliers seeking to partner with bioprocessing clients.
Sourcing Assurance & Control
Bioprocessing customers prioritize partners that can provide assurance of supply. Many customers are looking to partner with suppliers that offer control and redundancies over raw materials. Potential suppliers that can demonstrate sourcing alliances with different vendors or can identify new sourcing solutions will be in a better position to win customers.
Bioprocessing customers dislike “single source” suppliers but will select them if there is no other choice. However, suppliers must provide assurances that the vendor’s supply chain is stable and offers flexibility of “n – 1” raw materials from its raw materials providers (the supplier is considered n and its sub-component supplier is n-1). Quality standards from “n – 1” are not required but are expected.
Scalability, Quality & Performance
Bioprocessing customers often test vendors’ ability to meet customer requirements by starting off small and scaling in the future. This requires the vendor to ramp production capacity to meet the needs of customers. Often, these bioprocessing customers may be more lax on certain requirements based on future expectations that the vendor will work to meet those requirements in the future. Typically, the customer tests a small volume of goods/services before placing a much larger order, and only does so after proving that the item meets their needs. In this time, the customer expects the vendor to improve its quality operations to meet functional, operational, quality and regulatory requirements.
Entering the bioprocessing market requires a strategic approach that involves various considerations. To successfully compete in this market, suppliers need to focus on process development, conforming to industry standards, sourcing assurance, integration, and scalability. These key factors can help suppliers expand their footprint and win new business.
