Complex biologics have become a major driver of the markets’ growing demand for new biopharma products. As more and more of these drug products enter the global pipeline, they’re also spurring demand for increasingly sophisticated drug development and manufacturing solutions.
Several major market shitfs are driving the value of a strong, strategic CDMO partner
Cost and complexity. Sensitive biologics have equally complex production requirements. Biotechs developing these compounds not only need to achieve uncompromising production standards, but also ensure the compatibility of packaging materials, develop efficient processes, meet crucial timelines for clinical trials, and speed up regulatory approvals. The right CDMO can help reach all these goals.
Specialized medicines. Orphan drugs and rare diseases require smaller batch sizes that can increase the challenge of optimizing production. Specialized medicines require innovative, flexible manufacturing solutions that require an expert partner.
Digital Innovations. CDMOs are playing an active role in supporting the inevitable shift toward “Pharma 4.0,” the convergence of industrial production and information technology.
How CDMOs solve drug development challenges
As these trends continue and intensify, CDMOs are serving as vital strategic partners, supporting biotech and pharma companies in a growing number of ways that streamline and accelerate complex drug development processes.
A CDMO’s insights and expertise can have a profound impact on critical project parameters: especially lead time, cost, and profitability. This is especially true for small biotech companies with finite development resources, lean teams, and little margin for error in their development pathways. The right CDMO can help a biotech navigate potential pitfalls, stay on track to their clinical development goals, and protect the value of their company and product.
Specialized skills, resources, and infrastructure
Many companies increasingly see strategic CDMO partnerships as a way to augment lean internal teams with as-needed talent, on-demand resources, and state-of-the-art manufacturing infrastructure.
CDMOs give biotech partners access to expertise and dedicated skillsets that complement the sponsor’s core competencies, enabling product teams to ensure production quality while staying focused on what they do best.
Guidance when it matters most
Biotech companies face numerous hurdles throughout the drug development process, from clinical development timelines, to rapid commercial scale-ups, to byzantine regulatory pathways.
Strategic CDMOs increasingly offer insight, experience, and careful, thoughtful approaches to navigating each of these challenges, helping their partners identify business priorities, navigate the regulatory maze, and stay on top of trends in a dynamic market.
According to Henrik Oberle, Vice President Development Service at Vetter, this trend has led many biotech and pharma companies to expand and deepen their partnership with CDMOs.
“Many biotech companies see CDMOs as extensions of their own service portfolio,” he noted in a recent interview with LabioTech.eu. Biotech companies increasingly “expecting a partner with the ability to be flexible, efficient, and innovative, and provide holistic consultation that enables complex drugs to reach the market quickly and reliably.”
Choosing the right CDMO
Four key factors determine if a CDMO can add to the drug development process:
- Extensive experience
- Cultural fit
- Corporate stability
- Long-term resource
In our 40+ years of experience with complex biologics, these attributes have been consistently critical to a successful biotech-CDMO partnership.
Each of these four factors is vital across the product lifecycle, from early-stage development through phase III and market launch – which is why they will always be at the heart of our collaboration with every company we partner with.
The biotech-CDMO partnership will only further deepen as new markets, demographic changes, and product requirements increase the need for flexible and innovative approaches to drug development.
With our expertise, resources, and commitment, our partners can keep their focus where it belongs: on swiftly, efficiently, and successfully bringing new drugs for patients in need.