Edition 2 / June 2020
Dr. Mimoun Ayoub,
VP, Global Head of Sales & Key Account Management
Like the rest of the pharmaceutical industry at the onset of the pandemic, CordenPharma faced the complex challenge of implementing guidelines and procedures to protect employees, adapting to a new paradigm in customer communication strategy, and ensuring essential business continuity from cGMP manufacturing sites across two continents and six countries (Brussels, France, Germany, Italy, Switzerland and USA). Our response to the crisis had to be immediate, globally aligned and most importantly, without disruption to our customers’ supply chain for critical medications to patients globally.
We began with the creation of a COVID-19 Customer Update and video message from CEO Dr. Michael Quirmbach. After quickly adopting a crisis mindset and management team, we set about the task of adjusting our company culture and business processes while maintaining the focus on quality and patient safety. We have proven that our core pillars of Customer Centricity & Service, Operational Excellence, Collaborative Partnership, and People & Culture have never been more important as guides in navigating forward.
The constant & close exchange among the Global Crisis Executive Leadership Team ensured not only that our development & manufacturing assets were and remain fully operational, but also helped support our facilities to deliver a higher demand of critical care products for COVID-19 patients such as:
The protection of all CordenPharma employees, whether working remotely or in our network of facilities, remains the highest priority. To that end, we immediately implemented measures such as additional Personal Protection Equipment, sanitizers, de-contamination processes, gowning, increased cleaning frequency and other mitigation tools to avoid infection risks, all of which are now integrated into normal business procedures.
In order to maintain our integrated development and manufacturing services, CordenPharma has undergone tremendous efforts to mitigate supply chain risks by increasing & re-allocating resources and re-prioritizing its product portfolio to adjust to customer delays in clinical trials triggered by the pandemic. Our more cautious, and therefore somewhat slower, approach to business processes at the sites, starting from personnel entry to the end of product release, has proven key to success in avoiding COVID-19 infection and spread of the virus.
By working overtime and adding temporary personnel to counterbalance this slower pace driven by COVID-19, we are committed to delivering on our supply chain promises, despite the pandemic. We also rely now more than ever on our prudent sourcing strategy, especially for commercial products, where buffers of starting materials and components are always available.
CordenPharma’s Fully-Integrated Supply, supported by our network of cGMP facilities for the manufacture of APIs, Drug Products and Packaging, is an important asset in mitigating the challenges of such unprecedented circumstances. In this new era, where time & resources are of the essence, our integrated supply model provides added value to our customers at a time when traditional, highly fragmented supply chain strategies relying on several suppliers across the globe are no longer viable.
The healthcare ecosystem has changed substantially, and with that, CDMOs must adjust very quickly. Flexibility is key to keeping up with the constantly changing priorities, especially for opportunities to support COVID-19 vaccines and medications. CordenPharma fully understands this is a race – one that, as your CDMO partner, we will fully support to the finish line. Our integrated API & Drug Product manufacturing services, especially for Injectable Drug Products, are key to accelerating that timeline to market.
Under the CordenPharma Injectables Platform, CordenPharma’s Injectable Drug Product facility, based near Milan in Caponago, Italy, is a cGMP manufacturer of sterile liquid dosage forms for injectable use, with specialized expertise in Terminal Sterilization, Sterile Emulsion, and Aseptic Fill & Finish. This available capacity is particularly suited for accelerated Coronavirus vaccine development & manufacturing projects.
On May 28th, CordenPharma & Moderna announced an extended Lipid Supply Agreement for Moderna’s mRNA-1273 vaccine candidate. Organized under the Peptides, Lipids & Carbohydrates Platform, the amended agreement now includes CordenPharma Chenôve (FR) and CordenPharma Colorado (US) for the manufacture of larger-scale volumes of lipids, while continuing to draw upon CordenPharma Switzerland’s long-standing reputation as a leader in specialized lipid manufacturing.
What is the post-pandemic pharmaceutical landscape going to look like?
The pandemic has triggered a lot of geopolitics, which ultimately might impact tomorrow’s CDMO business in terms of governmental & trade rules encouraging a return to local development and manufacturing activity. Where geographical risk used to be a more theoretical consideration of value chain, it has now become an integral part of it. To illustrate this, we have seen multiple customers shift their API and Drug Product supply requests to Europe and the US, where they used to be sourced in India and China.
Pushed by the lockdown, we have demonstrated more presence to close communication gaps with our customers by intensifying virtual meetings. We are working on several digital tools geared towards more transparency, which give customers added comfort to move forward with their projects, despite the travel restrictions.
Our enhanced onsite and virtual efforts and track-record of successful inspections by major health authorities has allowed the FDA approval of a world-class drug launch from our oral solid dosage Highly Potent Drug Product manufacturing plant in Plankstadt, Germany. Our CordenPharma Caponago injectable Drug Product facility in Italy underwent a similar approach due to travel restrictions, and is now expecting the launch of another world-class Injectable Drug Product in the near future. These successes are the best demonstration of our commitment to compliance during this crisis. We have managed to complete complex validations and support drug launches in collaboration with our customers despite the pandemic spread, with further product launches expected in the near future.
CordenPharma has taken a prudent and strong approach to the pandemic, and we will maintain our efforts indefinitely. We hope our solid, yet flexible foundation will continue to be a valuable asset to customers. Please click here to submit any questions or feedback you may have regarding COVID-19, as we value your input. We wish you, your companies and the industry at large stay healthy & safe!
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