October 24, 2023
HOW TO CHOOSE THE RIGHT CDMO PARTNER
CDMOs are an efficient alternative to the in-house development process. ABL’s sole focus is on product development and manufacturing, allowing us to help our customers bring products to market more swiftly. However, choosing the right CDMO is much more than simply finding a provider to outsource the development of your therapy: it’s also about choosing a partner with the right expertise and a willingness to learn about your patients’ needs, to ensure the success of your company.
What are the top three qualities to look for in a CDMO partner?
1. Technical and Knowledge Capability
One of the most important things to consider is the technical knowledge you require. From simple questions such as how long the CDMO has been around to its physical capacity to deliver products, this all has to be taken into account to make sure the partner you choose has what it takes to develop your therapy.
Commercial activities represent the bulk of the CDMO market, with an 88% share in 2022.1
At ABL, a pure play viral vector CDMO, we have decades of experience under GMP conditions and a proven track record in the manufacturing of biologics, with over 25 years in oncolytics and, since 2016, in viral vector-based vaccine candidates. We also have extensive experience in US & European regulatory compliance, to help our customers meet global GMP product requirements and guide them through the regulatory approval landscape with speed and flexibility. GMP compliance is crucial, as is the scaling up process and the availability of quality control testing facilities during the commercial phase.
Decades of experience are not the only factor: you must also consider the CDMO’s ability to deliver on time. Has the CDMO demonstrated a willingness to learn and adapt to its customer base, to keep up with technological advances? At ABL, we emphasize a collaborative relationship; we’re open to learning from our customers, tailoring our offer as close as possible to the market’s needs.
In 2016, we started offering CDMO services with AAVs manufacturing clinical candidates through adherent and suspension processes. In 2022, we partnered with a biotech company specialized in AAV gene therapy development. That same year, taking advantage of our significant expertise in virology and cell culture, we began developing our high predictable yield and versatile AAV platform.
Knowledge must be backed up with technical capability; therefore, you need to consider what expectations you have for the CDMO. Do they have the full range of services you require? Could a collaborative partnership with several CDMOs and CROs work for your drug or can one CDMO meet all your needs?
We are an end-to-end CDMO partner, which means we can guide you through your process development, tech transfer, validation and Quality Assurance, all the way to a complete Chemistry, Manufacturing and Control (CMC) package and documentation. By utilizing a single CDMO partner, you gain smoother communication, due to fewer players in the process, and reduced costs. Therefore, picking the right partner is a balance between expertise and the ability to provide the knowledge to assist in bringing your product to market.
2. Quality-Efficiency balance
Initiating a collaboration with a CDMO that can foster an efficient manufacturing process and produce high-quality products should be the most important factor for pharma and biotech companies to consider. Taking the route of speed and cost cutting in the development of a drug accomplishes nothing if it fails to match commercial and/or regulatory quality standards. You could end up spending more time rectifying any shortcuts taken in the original process. At the same time, taking too much time and seeing costs soar can be off-putting for smaller companies looking to outsource development. So, how does ABL strike the right balance?
We follow our customer centered approach and prioritize project timelines without compromising on the quality of the end-product. Our Quality Control (QC) department, located at our Strasbourg site, is multi-skilled and can design robust quality control packages, help identify relevant and essential analytical methods for product characterization and process-related impurities, and qualify and validate analytical methods.
Ultimately, we believe that early definition of its QC strategy, as well as the robustness of its analytical methods, are critical steps on the path to any project’s successful development.
3. Customer experience
Europe accounts for the second largest share in the global CDMO market2; the biopharma market is also evolving rapidly, with changing needs. This is why CDMOs must take a client-centered approach in order to deliver on project expectations and foster long-term strategic partnerships. At ABL, we strive to understand our clients, fully incorporating their goals, motivation and company values to ensure we can select the best approach for each project3. For ABL, being ‘Customer Centric’ means that at every level of the company we are committed to supplying our customers with best-in-class services. We believe that each customer is unique and needs tailored solutions. As much as a CDMO can advise and guide a client, it can also learn from them, which is why we foster a flexible and collaborative working relationship.
Practically, we aim to be there for our clients. We operate from two sites in France, Lyon and Strasbourg, to support customer demand. We have also developed a 360° virtual tour to remotely showcase our facilities, our capabilities and our teams to our clients around the world. Together with our experts, clients can explore, at their convenience, our state-of-the-art facilities, from process development to GMP manufacturing, including our QC laboratory.
Choosing the right CDMO for your success
As many more new biotech and pharma companies appear on the scene, the demand for CDMOs is expanding. With the drug development process being such a lengthy one, it is important to select the right long-term partner to optimize the development of your innovations. There are many factors to consider, from technology and experience to quality and efficiency of the CDMO, but ultimately, the most important thing to look for when selecting a CDMO, beyond choosing a provider, is finding a partner that values true collaboration.
Are you ready to pick your new CDMO partner?
Contact us to find out how we can support your manufacturing needs: email@example.com