As demand for biopharmaceuticals continues to increase, expanding manufacturing capacity to maximize productivity is key. However, increased production capacity necessitates more raw materials.
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Though meeting scale-up needs or increasing sales volume may be possible with a single supplier, finite capacity or limited availability can make it difficult for the supplier to meet high demands for raw materials. As a result, many biopharma manufacturers are beginning to leverage secondary and tertiary suppliers of critical raw materials, such as cell culture media. In fact, qualifying additional suppliers may be essential for manufacturers to simply maintain capacity in the event of unforeseen circumstances. For example, halts in production due to failed inspections or facility shutdowns can directly impact the availability of critical raw materials. Global issues &#; such as SARS-CoV-2-related supply interruptions and shipping constraints &#; can also limit supply. Whether a manufacturer is looking for a supplier to increase its output or as a secondary source in times of need, securing multiple suppliers is a crucial step in keeping production on track.
When it comes to securing suppliers, manufacturers must successfully qualify the supplier and confirm they can meet their requirements. Ideally, this should be done proactively ahead of a critical need.
The first step in selecting an additional supplier is identifying those that can support your specific requirements. If you are looking for a media supplier to manufacture your media formulation, this may mean that you need one who can source the 100 components that make up your formulation and manufacture it in-house. Conversely, you may be looking for a supplier who can supply a small number of specific raw materials so you can manufacture your own medium. Understanding your requirements will streamline the selection of a secondary supplier.
Working with a media supplier who has qualified multiple sources is also an ideal approach to improve access to critical raw materials. Global suppliers typically procure raw materials from several different sources, creating secondary and tertiary supplies of their own raw materials in-house. For instance, a supplier would have a primary supply of a critical raw material, such as trypsin, but would also have qualified additional suppliers in case of a problem with their primary source &#; such as low quality or supply interruption. The materials from all these suppliers would have undergone the same testing to confirm quality and establish redundancy.
Considering the origin of your media supply is also important when selecting a supplier as it can help alleviate supply concerns while maintaining production. For instance, does a potential supplier have one facility that produces one of your critical raw materials? Or is it redundantly manufactured at multiple facilities across the globe? The latter helps safeguard the supply of your critical raw materials, even if supply shortages or shipping challenges occur.
A growing industry combined with potential instabilities in global markets means that media suppliers are also acutely aware of how important it is to be able to supply products confidently and continuously. As such, many suppliers are investing in expanding capacity and volume to meet this demand, ranging from large investments (for example, construction of new facilities with increased capabilities) to more minor investments (for example, improving internal processes). Ultimately, these improvements are helping to increase the volume and reliability of raw material supply to meet increasing demand.
Though the qualification process for new suppliers may differ depending on the specific needs of a project, process, or company, several key steps help streamline the process.
i. Confirm quality. First and foremost, when qualifying a new supplier, you need to confirm the quality of the products you are procuring. You&#;ll want to ensure your media supplier strictly follows its own best practices and has an established standard operating procedure to confirm the quality of their raw materials.
Though suppliers have their own qualification requirements, it is still important for you to confirm this quality. Establishing your quality audit process is important; your specific requirements may differ from other companies.
ii. Confirm that specific processes or protocols are followed. After confirming the quality of the raw materials provided by a secondary media supplier, it is also important to confirm that any required processes or protocols are followed. For specific raw materials, this may range from confirming segregation of animal origin and animal origin-free products in-house to confirming the milling techniques used to create dry powder formats. If you are qualifying a supplier for the manufacture of your formulation, it is important to audit and qualify the specific manufacturing process, as well as the raw materials. Walking through how your medium will be manufactured in-house during a site visit is recommended. Such visits can be an important step in alleviating any concerns and confirming the techniques and equipment used are standard and appropriate for your needs. Finally, though site visits are important, virtual site visits have been gaining popularity as a suitable alternative.
iii. Confirm the accuracy of your products. Whether you are qualifying the production of a complex formulation from your secondary media supplier or a handful of critical raw materials, it is also important to test the products and confirm their identity. For many manufacturers, a documentation packet, such as a certificate of analysis, may be sufficient. However, depending on your requirements, a more in-depth audit of finished goods may also be necessary before qualifying a new supplier. Identity testing multiple lots of a medium formulation or going through individual raw materials, pulling batch records, and analyzing the documentation to confirm quality may be important to qualify your product.
iv. Confirm site-to-site equivalency. Site-to-site equivalency should be clearly demonstrated by media suppliers. Oftentimes, equivalency begins with procedures and practices around the supply chain and includes processes for quality management system alignment and harmonization, manufacturing, and equipment equivalency. Batch testing across the network should also be performed by manufacturers to confirm equivalency. Equivalency documentation or an audit may be sufficient to accept a material produced at multiple sites. Conversely, you may require multiple batches of a given product to demonstrate that the same product being manufactured at different sites performs equivalently in your process. Site visits may also be performed to confirm equivalency within a global network.
v. Confirm supply chain reliability. Though this is not strictly a necessity, when it comes to the qualification process, confirming the reliability of your new media supplier&#;s supply chain is advisable. Evidence of a dependable supply chain should be provided upfront alongside discussions of any specifics of what will be provided. Though you may have already done this with a primary supplier, confirming with a secondary or tertiary supplier is just as important &#; whether they will be supplying raw materials in tandem with your primary supplier or only when the need arises.
vi. Establish transparent communication. Establishing a transparent communication system to share data is critical &#; from being alerted to supply updates or changes to any necessary quality documentation or paperwork. Ultimately, these systems can help keep things running on schedule and identify any potential issues.
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Given the increase in global demand, it has never been more important to consider whether qualifying additional suppliers is necessary to support the uninterrupted production of your essential biopharmaceutical products. Proactively qualifying additional media suppliers ahead of a critical need can mitigate the risk of costly delays to your process &#; all while supporting your ability to provide life-changing therapeutics to the people who need them most.
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Biopharmaceutical companies rely on a dependable supply of raw materials to ensure they can continue to supply patients with often life-saving medicines. Significant changes in industry&#;s research areas (e.g., oncology) will continue to impact clinical and commercial supply strategies and overall market demand for raw materials over the next few years.
Covid-19 is perhaps one of the clearest examples of the interdependency of pharmaceutical supply chains, demonstrating the challenges of relying on single suppliers and the difficulty of finding flexibility around substituting raw materials.
This document communicates a strategic framework for solving technical problems relating to managing raw materials in the biopharmaceutical industry. It also encourages biopharmaceutical end-users and suppliers to work together to address specific raw material and end-user process needs.
In addition, it highlights the importance of implementing industry solutions and directs readers to BioPhorum Raw Materials Program publications. These establish standard definitions, a common understanding of raw material requirements, and the importance of regulatory, quality, and supply chain links. They also provide education and information for biomanufacturers and their suppliers.
The framework contains technical, regulatory, quality, and supply chain considerations and may be of interest to stakeholders working with both new and commercial products, including:
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