Ensuring the quality of raw materials is a crucial component of achieving product quality of APIs and finished drug products.
Biopharmaceutical manufacturers are looking to their raw-material suppliers to provide them with the support of a secure supply chain. To gain a perspective, Cynthia Challener, PhD and editor of the Pharmaceutical Sciences, Manufacturing, and Marketplace Report, recently spoke to Beth Ann McLane, SAFC’s product manager for enhanced quality, of the importance of ensuring supply-chain transparency and quality for raw materials. SAFC recently introduced a line of PharmaGrade products for raw materials for biopharmaceutical applications.
Public demand for increased supply chain securityPharmaceutical Sciences, Manufacturing and Marketplace Report: What situation led to the decision to develop your new PharmaGrade raw materials for the biopharmaceutical industry?
Mclane (SAFC): Biopharmaceutical manufacturers are faced, now more than ever, with the reality of global events that have threatened and breached supply-chain security. These occurrences have caused a public outcry, and regulatory bodies have demanded higher levels of compliance. Manufacturers are now being held fully responsible for the raw materials that go into their products, and they simply do not have enough capacity to test for all of the possible contaminants that could find their way into the materials.
In response, the industry is moving towards risk assessment and risk mitigation of raw materials from the early stages; in essence, manufacturers are looking to their raw-material suppliers to provide them with the support of a secure supply chain. The more that biopharmaceutical manufacturers know about their suppliers and the raw-material supply chain, the more confident they can then be about the safety of those raw materials.
Improving supply chain transparencyPharmaceutical Sciences, Manufacturing and Marketplace Report: How is the introduction of a new grade of pharmaceutical raw materials anticipated to fill these market needs?
Mclane (SAFC): PharmaGrade products were developed to provide better supply-chain transparency and manufacturing controls; they are a lower-risk option to use in manufacturing than many currently available raw materials. The portfolio was created in response to urgent demand from customers for products they can count on to be consistent and that are from a source where the production is controlled and changes are limited. These types of customers are not only looking for a guaranteed level of quality, but they also want to know what is happening with the raw materials and to be notified if/when any changes occur.
When we started to build the product line, we anticipated that customers would be looking for a higher level of documentation and support than ever before. In response to this expectation, we have put a great amount of resources into identifying and qualifying products for the line. In addition, SAFC has a strong change control notification system and offers robust support, especially for our GMP and Elite quality-level products.The Elite products provide an option for customers that are looking for highly controlled products, but do not necessarily need them to meet the same level of validation as required by GMP guidelines.
Ensuring audit-worthiness of key ingredientsPharmaceutical Sciences, Manufacturing and Marketplace Report: What are the specifications/requirements for the new grade of raw materials? How were these determined? How are they different from existing raw materials?
Mclane (SAFC): SAFC’s goal is to hit seven key criteria for the new materials that were directly based off of customer requests. The first six are:
The challenge for raw-material suppliers has been to produce and sell raw materials that can stand up to an audit. As such, one of our key goals is to make sure customers know what they are buying and are satisfied that the products meet their expectations for quality and documentation when they audit. The seventh, and perhaps, the most important criterion, is to have these products available as catalog items in inventory, so customers can have access to them when they need them.
Pharmaceutical Sciences, Manufacturing and Marketplace Report: Which types of materials is SAFC looking to offer at this new grade? How/why were they selected?
Mclane (SAFC): SAFC is offering a broad range of amino acids, buffers, and specialty chemicals as PharmaGrade materials. These chemicals were selected because they are components with known usage in biopharmaceutical manufacturing. We knew they would appeal to a broad number of customers.An example of a product we offer is L-methionine sulfoximine, which is used as a selection agent. Until SAFC introduced the PharmaGrade version of the product, the other products available in the market were not made at the same high quality level, under controlled processes, and with the same supply-chain transparency. Additionally, we wanted to be sure to offer commonly used chemicals, such as sodium butyrate, L-tyrosine, and disodium salt.
The challengePharmaceutical Sciences, Manufacturing and Marketplace Report: How has the introduction of the new grade of raw materials affected SAFC’s suppliers and customers? What feedback have you received?
Mclane (SAFC): Many of our customers have been eagerly looking forward to the introduction of new PharmaGrade products, and the feedback has been very positive. They have been extremely pleased with the readily available inventory of each of our products as well as the enhanced quality product documentation that comes with them.
Each product has a complete dossier of information about it, including the site of manufacture and quality systems associated with the product. We are directly responding to customer requests for products that are available when they need them and in the format they need them. Customers have clearly expressed that they want us to expand the offering as quickly as possible.
The only real issue we have had is delays in adding new products to the line due to requirements we expect from suppliers. This line of products requires that our suppliers provide us the detailed information about raw materials and procured products so that we can offer the full level of supply-chain transparency expected with the PharmaGrade portfolio. If we realize that a product cannot meet the standards, then we will not move forward in adding it to the line. Or if we realize that we need longer to verify the standards, then we will take the time to make sure that happens.
Continued expansionPharmaceutical Sciences, Manufacturing and Marketplace Report: What can be expected in the short-term and long-term with respect to the PharmaGrade products for biopharmaceutical manufacturing?
Mclane (SAFC): SAFC offers PharmaGrade products globally, and we will continue to launch new products globally each quarter. Our immediate plan is to double the size of the PharmaGrade portfolio by the end of 2013. Our long-term goal is to create a full line of products for biopharmaceutical manufacturing with the right supply-chain transparency and control to help customers reduce the risk in their raw materials and, ultimately, their final products.