Leveraging virtual manufacturing to build secure supply chainsBy James Lawler, Head of Quality at C2 PHARMA - 2nd September 2019
James Lawler, Head of Quality at C2 PHARMA, explains how the implementation of virtual manufacturing strategies can ensure supply chain security and the reliable delivery of high-quality therapeutic products.
Guaranteeing the supply of medicines is absolutely essential for ensuring patient health and wellbeing. Shortages of critical drugs such as those on the World Health Organization’s List of Essential Medicines can lead to dire consequences for patients that rely on these life-saving products. As such, drug companies must implement sourcing and manufacturing strategies that will ensure security of the supply chain and the continual, reliable delivery of high-quality therapeutic products regardless of unexpected events (natural disasters, equipment failures, raw material contamination, etc).
As a manufacturer and distributor of phyto and synthetic active pharmaceutical ingredients (APIs), C2 PHARMA faces numerous challenges to establishing a secure supply chain. We have therefore been highly proactive in implementing strategies designed to minimize and manage these challenges.
A key aspect of our strategy has been to develop and implement an innovative virtual manufacturing approach. C2 PHARMA does not physically own any manufacturing facilities, but contracts out all development, production and analysis activities to third-party service providers. We own our drug master files (DMF) or similar registrations filed with relevant regulatory authorities, and therefore have full legal responsibility for the appropriate manufacture of our drug products and the regulatory filings.
We live up to our responsibility of a virtual manufacturer by having quality oversight over our contract manufacturing organizations (CMO), beyond that which has been traditionally ‘standard’ in the industry. Our quality management system ensures full oversight of the entire manufacturing process from start to finish. Our change-management control processes prevent any process change from being implemented without prior review and written sign-off from C2 PHARMA. In addition, we carry out onsite reviews of batch documentation, QC data, risk assessments, and more.
The production of natural product APIs requires a variety of unique skill sets, including extraction using a variety of solvents, fermentation and synthetic chemistry. The equipment and technical capabilities involved for each of these processes are different, and rarely does any one CMO have expertise in all of these areas.
C2 PHARMA’s virtual manufacturing strategy enables us to choose the best and most reliable CMOs, with specialized capabilities that fit our needs for each individual API. We select only the most qualified CMOs after completing a comprehensive due diligence process that considers the technical ability and the safety, quality and compliance history of potential outsourcing partners at all stages from raw material sourcing practices to testing, manufacturing and product release.
The virtual manufacturer setup also affords C2 PHARMA tremendous flexibility and nimbleness; we are able to respond much more quickly to market or customer needs than would be possible with the corporate bureaucracy that accompanies large, traditional API manufacturers.
As a small to medium-sized company, outsourcing is also more cost-effective for us. We avoid the financial burden and pressure associated with the high capital investment and operating expenses required to build/acquire and maintain a pharmaceutical production plant.
Even large pharmaceutical companies are leveraging the benefits of the virtual manufacturing model, particularly for mature APIs they want to maintain in their portfolios but for which they need to increase efficiencies and reduce costs.
Perhaps most importantly, the flexibility we gain by working with multiple CMOs in various parts of the world with wholly independent supply chains significantly enhances our ability to ensure security of supply for our APIs. If there are problems at one CMO, we can still provide critical drug products to our customers from another CMO.
As an example, C2 PHARMA currently contracts the manufacture of digoxin, a well-known, life-saving, microdosed API for the treatment of various heart conditions that is on the WHO essential medicines list. The production process is highly complex and requires continuous investment, focus and dedication. To ensure the secure supply of digoxin, we have developed a redundant supply chain, thus preventing shortages (previously a common occurrence) from happening in the future.
At CMO Laurus Labs in Vizag, India, C2 PHARMA invested more than US$10 million in a dedicated, cutting-edge production facility and supply chain for digoxin. In this case, we own the physical infrastructure, but the day-to-day operations, quality control and assurance, testing and product release are managed by the CMO. Investment in the infrastructure was made to guarantee the supply of digoxin long into the future.
C2 Pharma also acquired the digoxin API product portfolio of the Polish company Nobilus Ent, which was self-developed and inherited from Roche/Galenus Mannheim. Nobilus will continue to be our manufacturing partner and releasing entity for this API.
Each of these CMOs relies on a separate supply chain of leaves, enabling C2 PHARMA to ensure a unique and redundant supply of digoxin API. Both the European and Indian sites have been audited by regulatory authorities in the US, Europe and Asia.
James Lawler, Head of Quality at C2 PHARMA, 270, Rue de Neudorf, L-2222, Luxembourg, Grand Duchy of Luxembourg
T: +352 28 26 11 00
T: +352 28 26 11 00