When considering primary and secondary sourcing options, it is important to balance price and security of supply. Partnering with an integrated, Western contract development and manufacturing organization (CDMO) with large-volume production capabilities for registered starting materials (RSMs), advanced intermediates, and active pharmaceutical ingredients (APIs) can provide countless advantages, including reliability and superior communication, at a competitive cost.
Quality and Reliability Benefits of Partnering with European CDMOs
Even just 10 years ago, it was common practice for pharmaceutical companies to purchase RSMs and intermediates from low-cost manufacturers in China and India. Cheap labor and limited environmental and safety regulations led to significant cost differentials.
However, in the past few years the Chinese government has implemented new environmental, health, and safety regulations and policies moving closer to the stricter requirements found in Western countries. Many older Chinese plants have been shuttered, and additional closures continue to occur on a frequent basis. Prices are rising, and in some cases products are no longer available, leading to significant supply interruptions while a new source is established. In India, issues related to quality problems are frequently reported by established pharmaceutical newsletters and often can be traced back to noncompliance with cGMP manufacturing requirements. In 2019, Indian pharmaceutical companies received 19 of the 41 warning letters issued by the U.S. FDA, the country’s most in four years.1 In some cases, these quality issues are severe enough to halt import of products into Western countries.
Regardless of where a CDMO is located, pharmaceutical companies should look to partner with service providers that are committed to forming strategic collaborations and long-term relationships.
The best CDMOs have sound financials and long track records of quality and compliance (safety, health, environmental, and manufacturing) performance. For API and intermediate suppliers, GMP compliance according to ICH Q7 pharmaceutical manufacturing guidelines and approvals from global regulatory authorities are essential. For RSM suppliers, compliance with ISO 9001 and similar guidelines should be required.
Communication is Essential
Beyond quality and compliance, another essential attribute for CDMOs is open and transparent communications. Every project will face technical challenges; what matters is how the CDMO handles them. Sponsors should look for CDMO partners that communicate problems immediately, propose potential solutions, and work with their customers to identify and implement the best options. Well written reports, validation protocols, deviation reports, and email communications form the knowledge base necessary for successful filings by the sponsor. Gaps in communication can lead to knowledge gaps and the need for additional time and resources to fill these gaps before filing a new drug for approval, or more significantly a delay in filing, and worst of all a complete response letter delaying approval.
Maintaining the Right Balance
When considering primary and secondary sourcing options, it is important to balance price and security of supply. To establish a secure supply chain, there is often a higher upfront investment required. In the long term, however, the savings can be significant. Frequent trips to a supplier, hours spent trying to understand the true picture within a CMO, or interruptions of supply that result in products being delayed, withdrawn, or never reaching the market carry a much higher cost.
Beyond quality and compliance, another essential attribute for CDMOs is open and transparent communications.
FAREVA: Leveraging Integration
FAREVA is a European-headquartered API and drug product manufacturer with 15 pharmaceutical sites in different countries, including three API sites located in France and Germany. We have integrated expertise to manufacture RSMs, advanced intermediates, APIs, and drug products with chemical processing, analytical and formulation development, scale-up, regulatory compliance, and manufacturing of both clinical and commercial batches.
FAREVA’s dosage form capabilities include injectable, semisolid, liquid, ophthalmic, and oral solid dosage capability, including highly potent drug products. API capabilities include conventional API manufacturing with large-volume reactors, highly potent API, sterile crystallization, and spray drying.
With our global footprint, FAREVA can operate both as a primary and secondary source. Manufacture of RSMs, advanced intermediates, and APIs can take place at multiple sites, ensuring security of supply.
In addition, with FAREVA capable of manufacturing the RSMs, intermediates, and APIs, customers can choose to leverage an integrated supply chain, reducing the individual component forecasting requirements while ensuring the highest quality. Utilizing the FAREVA integrated supply chain, the sponsor can also reduce the audit burden required when working with multiple CMOs located across continents and time zones and using differing languages across the supply chain.
- Jayakumar, P.B. “USFDA slaps 19 warning letters to Indian pharma firms in 2019; highest in 4 years.” Business Today. 30 Dec. 2019. Web.