GMP Excipient & Raw Material Manufacturing and Sourcing Demands on the Rise

Material suppliers will face more scrutiny and will need a deeper understanding of manufacturing partners and sites, regulatory reputation and material quality, says Gearoid O'Rourke, Marketing Director at Aceto

Thus, material suppliers will face more scrutiny and will need a deeper understanding and knowledge of their manufacturing partners and sites, their regulatory reputation, and material quality. At 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 primary advantage remains our strong procurement teams that are strategically located in key regions, including those across Asia and Europe. These procurement professionals constantly keep in touch with our sales teams and provide real-time feedback on any potential delays.This further ensures that our customers are informed on-time and can plan their buying patterns accordingly.

Fulfilling Biologic Material Supply: An Approach to Meet Growing Excipient & Raw Materials Needs
Before COVID pandemia, the biologic medicines market was estimated to experience continued yearly growth over 10% and the rapid response of large molecule manufacturers to manufacture vaccines and other biologic drugs for COVID-19 is an another obvious cause for recent spikes in demand. Prior to the pandemic, Aceto had already recognized the growing demands in the biopharmaceutical industry for high quality critical GMP excipients and raw materials. As part of our growth strategy in the biopharmaceutical market we expanded our manufacturing footprint by acquiring five companies in the last 12 months, increasing our R&D and GMP manufacturing capabilities in North America, Europe and Asia. This robust GMP manufacturing presence in strategic geographical regions globally provides Aceto with the ability to respond to customers customization demands as well as providing specific manufacturing and R&D expertise to complement our existing distribution model. The five companies acquired were:

• A&C- a GMP manufacturer of excipients and raw materials for the biopharmaceutical market.
• Cascade Chemistry- a manufacturer of active pharmaceutical ingredients (APIs), regulatory starting materials and advanced intermediates.
• Finar- a GMP manufacturer, supplier, and distributor of pharmaceutical excipients.
• Islechem- a chemical manufacturing, also offers contract research and development (R&D), analytical services, and technical support services.
• Syntor Fine chemicals- a fine chemical manufacturer offering process development and R&D services.
   

Bringing Together Diverse Solutions to Secure Biopharma Supply Chains
Aceto’s manufacturing plants can provide customized functional excipients with full supporting regulatory and quality dossiers. In addition, we also have access to over 3,000 chemical compounds through our procurement centers of excellence globally. All our supply partners are approved and audited by our global quality auditing team. Our Quality Assurance and Quality Control teams are formed by highly skilled and qualified experts with many years of experience in the pharmaceutical & biopharmaceutical industry and work with our partners to ensure compliance with all pharmaceutical and biopharmaceutical standards and requirements is constantly respected. Aceto will only purchase products from specifically approved plants that meet our strict guidelines for quality. We regularly visit our partners to evaluate them not only on the basis of ability to deliver satisfactory products on a timely and cost-efficient basis, but also on quality system, facilities and equipment system, materials system, production system, packaging and labeling system, and laboratory control system.

Aceto offers customers a strong manufacturing base, to complement years of sourcing experience, and to bring customers more complete solutions. Our facilities, based in the US, Canada, UK, and India operate to both GMP and non-GMP quality standards depending on the application, and are backed by a globally aligned R&D organization. All facilities work closely with customers to develop advanced intermediates, APIs and excipients, as well as niche specialty chemicals.

Together, Aceto now manages over 5,000 international shipments of chemicals per year and boasts a market leading on-time in full rate. Key to this success has been Aceto’s regulatory team, which has over 70 years of quality and regulatory experience, with expertise working with agencies like FDA, European Medicines Agency (EMA), Registration, Evaluation, Authorization and Restriction of Chemicals (REACH), Environmental Protection Agency (EPA), Toxic Substances Control Act (TSCA), and Occupational Safety and Health Administration, 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 needed.