Recent global events, including COVID-19, have caused major disruption to global supply chains, resulting in significant pressure on the global supply of raw materials for the biopharmaceutical industry. As a result, it has become more critical than ever for raw material suppliers to be nimble in responding to rapidly changing expectations for customization, speed and delivery.
As a global manufacturer and marketer of critical raw materials and ingredients for the life science industry for over 75 years, Actylis (formerly Aceto) knows the importance of a flexible and reliable approach to creating and delivering custom materials that will enable biopharmaceutical developers to quickly achieve their commercialization goals. We focus on four key areas to ensure our customers receive top-notch service:
Customization of raw materials and reduction of impurities
Customization in biopharmaceuticals typically comes into play when standard excipients with slightly different purity profiles are required. For example, due to the nature and safety concerns of biopharmaceuticals, excipients may be required with low bioburden and minimal endotoxin levels. Additionally, many customers require these excipients in smaller quantities packaged in lot-specific packaging to minimize risk and waste.
Many large-scale commodity suppliers are not set up to meet niche customization demands. Instead, their business model requires the production of standard materials at scale to be profitable.
In this context, responsive and flexible raw material suppliers like Actylis are of immense value to many developers in the industry. We can support additional GMP manufacturing steps, while reducing impurity levels and providing the necessary support for customers in their development journey, from R&D to clinical and commercial phases.
Address supply chain issues with a hybrid approach
Global supply chain challenges are causing a significant slowdown in the distribution of raw materials and this is expected to continue. In these circumstances, Actylis was able to take advantage of its hybrid model by offering both manufacturing and sourcing options so that our customers have access to the most appropriate solution as soon as possible. We can offer a variety of options to customers and we work closely with them to choose the one that best suits their needs at that time.
Actylis has manufacturing plants in North America, Europe and India, and supply centers in China, the United States and Europe (among others), which allows our customers to choose the source of supply that best suits their drug development path.
Address capacity constraints
Many drugmakers are now facing capacity constraints as they continue to expand. Some struggle to maintain their ability to manufacture finished products, as a significant portion of their footprint may be required for in-house stamp manufacturing. Especially for a global enterprise, this balance of resources and infrastructure may not be feasible across a network of sites.
This is where an agile raw material supplier can play a key role – Actylis can offer the ability to outsource GMP buffers, process solutions and CIP solutions globally, through our network of manufacturing sites and supply in Europe, North America and Asia. With these options easily accessible from any part of our network, developers can confidently ease capacity constraints and focus more installation space on their core business.
A truly agile supplier
To become a truly agile provider, Actylis has invested heavily in understanding customer needs and we continue to do so through our customer-centric approach. This has allowed us to really connect with the challenges our customers face, whether they are product, quality or regulatory related. We remain focused on ensuring that we are, at all times, ready to provide optimal raw material solutions to our customers, whatever the challenge and wherever it is in the world.