To speed up drug development and commercialization, most biotechs partner with contract development and manufacturing organizations (CDMOs). Often though, they need to coordinate their project with more than one CDMO, as workflows have become increasingly complex. Recently, two companies have set up a CDMO alliance to simplify these processes for their biotech clients and make their lives easier.
As the share of biopharmaceuticals and other complex therapeutics in new drug development projects continues to grow, so does the need for professional manufacturing and commercialization support.
CDMOs usually specialize in individual steps of the drug development workflow to deliver the highest quality possible. The downside for the biotech clients is that they need to partner with more than one CDMO, increasing their workload and potential risks.
Introducing a new CDMO alliance
In mid-2020, two globally operating CDMOs, both headquartered in Germany, decided to set new standards to facilitate project coordination for their clients.
Building on their shared interest in better serving customers and achieving high quality, Rentschler Biopharma and Vetter formed an alliance to streamline their drug development and manufacturing processes.
Each CDMO brings in its particular expertise: While Rentschler Biopharma specializes in drug substance manufacturing, including bioprocess development and clinical and commercial active pharmaceutical ingredient (API) production, Vetter has long-standing experience in drug product manufacturing, including process design, as well as clinical and commercial fill and finish.
“Going from the lab to the clinic is a huge step,” stated John Moore, Director of Global Clinical Business Development at Vetter. “Together, we can guide our clients through the process with our integrated approach and dedicated project teams on both sides.”
Integrating drug development workflows
At the beginning of each joint project, and as soon as a three-way confidentiality agreement (CDA) is in place, biotechs receive an aligned questionnaire to enable early information sharing and exchange of know-how and best practices.
Usually, they work with Rentschler Biopharma at the start of the biopharmaceutical value chain, developing and optimizing the best-suited manufacturing process for the new drug substance at good manufacturing practice (GMP) scale.
Rentschler also takes care of stability studies, formulation development, and quality control procedures. Tailored towards client and product requirements, the final step is the production of API for clinical and commercial supply.
Shortly after initiating drug substance development activities, Vetter will develop an appropriate filling process, support the customer in selecting a suitable delivery system depending on the individual product characteristics, and implement the clinical manufacturing, followed by possible scale-up to commercialization.
“Complex biologic drugs make up approximately 80% of our projects. In addition to drug manufacturing, we also create secondary packaging accommodated to the needs of patients and caregivers – such as safety devices, pens, or autoinjectors. Last but not least, we also provide labeling and blister packaging services,” Moore explained.
A CDMO alliance securing quality and logistics
Both CDMO partners are committed to transparent and active information exchange between all involved departments. In previous joint projects, the two companies have aligned their approaches and processes right down to the type of materials and components they use to enable compatibility with each other’s systems.
The alignment of logistics departments and processes helps optimize the entire API supply chain and reduces transportation risks. The fact that the German sites of the two companies are only a 45 minutes drive away from each other is a great plus for the safe transportation of essential biopharmaceuticals.
In addition, both companies maintain sites in the US with logistic teams closely interacting to organize the safe arrival of samples, including the maintenance of secure cold chains.
“We must take utmost care of every batch we handle and process. Sometimes the batch we receive is the only batch that has been produced for a potentially life-saving product, and the entire company might be affected if it is lost or damaged,” Moore explained.
Commitment and communication are the keys to a good CDMO alliance
The two companies have also established transparent communication channels. Dedicated project management teams are set up on both sides, who sit down at one big table with the client.
“We have known each other and worked together for a long time. There is a strong commitment at the senior management level, and clear guidelines have been defined for our joint approach,” said Patrick Meyer, Senior Director of Business Development at Rentschler Biopharma.“
“If any issues do come up, we collaborate to solve them as quickly as possible and take full responsibility. This saves a lot of time for the biotech clients – they don’t need to spend valuable resources, but can rather rely on us, as their partners, to find solutions.”
Offering a free choice
Both companies continue to operate independently, so clients are free to set up contracts with both companies to benefit from the alliance or work with just one of the CDMOs. They can also integrate their project into the alliance at a later stage.
“We’ve received very positive feedback, and first contracts for joint projects are already in place, so we believe that this new CDMO alliance is the way to go for most of our clients,” Meyer added.
Interested in how your project can benefit from the new CDMO alliance? Find out here!
Images courtesy of Vetter and Rentschler Biopharma.