Growing demands for the sourcing and manufacturing of GMP excipients and raw materials

For CPhI Online, Gearoid O’Rourke

Suppliers of raw materials will come under increased scrutiny and require a deeper comprehension of manufacturing partners and sites, regulatory standing, and material quality.

Companies were forced to carefully reevaluate and rethink their current strategy after the Covid-19 pandemic exposed the vulnerability of the world’s biopharma supply chains. Pharma firms will persist in significantly reorienting their attention towards supply chain resilience and security.

As a result, material suppliers will come under increased scrutiny and will require a deeper comprehension of their manufacturing sites and partners, their regulatory standing, and the quality of their materials. At A&C and Aceto, we have long believed in following a strong sales, inventory, and operations (SIOP) process to mitigate any risks and ensure on-time delivery to our customers. Aceto’s main competitive advantage is still our robust procurement teams, which are positioned strategically throughout Europe and Asia. Our sales teams are in constant communication with these procurement specialists, who also give them immediate input on any delays that might occur. This further guarantees that our clients receive timely information so they can adjust their purchasing habits.

Supplying Biologic Materials: A Way to Address Increasing Requirements for Excipients and Raw Materials

The market for biologic medications was predicted to grow annually at a rate of more than 10% prior to the COVID pandemic. The quick response of big molecule producers to produce COVID-19 vaccines and other biologic medications is another clear reason for the recent surges in demand. Aceto was aware of the biopharmaceutical industry’s increasing need for critical GMP excipients and raw materials of superior quality even before the pandemic. We increased our R&D and GMP manufacturing capabilities in North America, Europe, and Asia by acquiring five companies in the last year as part of our growth strategy in the biopharmaceutical market. With a strong global GMP manufacturing presence in key locations, Aceto is able to respond to customer customization requests and offer specialized manufacturing and R&D knowledge to enhance our current distribution strategy. The five businesses that were purchased were:

A&C is a GMP producer of raw materials and excipients for the biopharmaceutical industry.
Cascade Chemistry is a producer of regulatory starting materials, advanced intermediates, and active pharmaceutical ingredients (APIs).
Finar is a GMP producer, distributor, and supplier of pharmaceutical excipients.
Chemical manufacturer Islechem also provides technical support, analytical, and contract research and development (R&D) services.
Syntor Fine Chemicals is a manufacturer of fine chemicals that provides R&D and process development services.

Combining Various Approaches to Safeguard Biopharmaceutical Supply Chains
Customized functional excipients with comprehensive supporting regulatory and quality dossiers are available from Aceto’s manufacturing facilities. Furthermore, we possess over 3,000 chemical compounds at our disposal thanks to our procurement centers of excellence situated worldwide. Our global quality auditing team approves and inspects each and every one of our suppliers. Our teams for quality assurance and quality control are made up of highly qualified professionals with years of experience in the pharmaceutical and biopharmaceutical industries. They collaborate with our partners to guarantee that all standards and regulations pertaining to these industries are consistently followed. Aceto will only buy goods from plants that have been specially approved and that satisfy our exacting standards for quality. We pay frequent visits to our partners in order to assess them on a variety of factors, including their capacity to produce high-quality goods in a timely and economical manner, as well as their systems for quality control, facilities and equipment, materials, production, packaging, labeling, and laboratory operations.

In addition to years of sourcing expertise, Aceto provides clients with a robust manufacturing base to enable them to receive more comprehensive solutions. Depending on the application, our facilities in the US, Canada, UK, and India adhere to both GMP and non-GMP quality standards. They are supported by an international R&D organization. Every facility collaborates closely with clients to create specialized specialty chemicals, advanced intermediates, APIs, and excipients.

Together, Aceto currently oversees more than 5,000 chemical shipments internationally annually and has a market-leading on-time in full rate. Aceto’s regulatory team, which has over 70 years of quality and regulatory experience, has been instrumental in this success. They have worked with the Environmental Protection Agency (EPA), the Food and Drug Administration (FDA), the European Medicines Agency (EMA), the Registration, Evaluation, Authorization, and Restriction of Chemicals (REACH), the Toxic Substances Control Act (TSCA), and OSHA standards. Knowing how to move highly regulated goods around the world is just as important as the ability to manufacturer them. To keep up with the growing biopharma space, suppliers must both diversify their global manufacturing capabilities and heavily invest in logistics. Doing so, will help bring more incredible biologic medicines to patients around the world, wherever they are needed.