For pharma and biotech companies, there are many advantages to partnering with a Contract Development and Manufacturing Organisations (CDMO): they can access more specialized knowledge, state-of-the-art equipment, and qualified staff, as well as reduce their total cost of ownership, all while maintaining speed to market.
Much of the innovation in pharma pipelines is currently driven by smaller – or even virtual – companies. These companies often have limited in-house resources for product development or scale-up, and so depend on CDMO partnerships to achieve development milestones.
To meet these expectations, CDMOs need to provide the right expertise, the right capabilities, and the right regulatory experience to help their customers bring products to market quickly, efficiently, and cost.
As both a CDMO and a manager of CMOs, Avéma Pharma Solutions sees the following trends emerging to build the CDMO of the future.
- Narrower Product Focus
- Emphasis on Development
- End-to-End Support and Manufacturing Flexibility
- Manufactured in the USA
- Continuous Reinvestment
1. Narrower product focus
While it’s tempting to choose a large CDMO that manufactures a wide range of products, it’s often better to find a company that focuses on a narrower band of core strengths. Avéma, for example, specialises in small molecule, oral solid, and liquid dose drugs.
Avéma’s team of scientists and manufacturing experts have more than 40 years of Rx formulation development expertise and decades of producing
generic drugs at both small development companies and multinational pharmaceutical companies. This unique pedigree gives the company a foundational understanding of how to launch products at every stage of development. And, because it also manufactures products, its staff is current on regulatory requirements and FDA/ICH Guidance documents.
Since CDMOs have different material handling capabilities, when choosing a partner, it’s important to understand if the drug will involve a controlled substance, hormone, small molecule or biological. This will help determine if there are any special handling requirements.
One of the first things Avéma does with a new project is to evaluate the drug molecule to make sure it’s a fit for available facilities. It examines the API from a safety perspective and ensures the handling requirements are within its comfort zone.
2. Emphasis on development
As pharma companies look to CDMOs for more support with product development, there is an increasing need for the CDMO to have in-house analytical development.
The early stages of formulation development typically take the longest as the target formulation needs to be defined, then placebo studies must be performed during method development to assure that the excipients do not interfere with the analytical peaks of interest.
The target formulation also needs to be in place to identify critical quality attributes, for the product to move to process design and qualification.
Developing methods to test an API is an important part of the regulatory approval process and is critical to keeping speed-to-market on target.
Occasionally, a customer may not have current validation methods established for a drug. This could be because the ANDA (abbreviated new drug application) had been dormant for many years, validation wasn’t required when the drug was developed, or the drug may have been transferred from a company that no longer has the records. Having the capabilities on-site to develop and validate methods helps ensure that product development and regulatory approvals stay on track.
3. End-to-end support and manufacturing flexibility
While the desire to maintain speed-to-market remains strong, Covid-19-associated delays have become common, encouraging pharma companies to seek new CDMO partners who can support drug development from start to finish with end-to-end capabilities.
Fully integrated development and manufacturing partners can minimise the impact of delays, improve overall efficiency, as well as minimising FDA information requests to enable a faster approval cycle.
A CDMO that can scale up from pilot runs to full-scale commercial production within the same facility is invaluable. When preparing a product for launch, it’s often preferable to start with smaller batch sizes that allow a company to evaluate the product during the manufacturing process before moving to large-scale production.
The pilot scale batches give a true characterisation of the process to design experiments to support the FDA’s expectations that the process will run consistently during commercial manufacturing. Pilot-scale production is faster and more cost-effective than doing full-scale demonstration batches on commercial equipment.
Small batches are particularly helpful when the company is developing a unique, small molecule NDA product. These APIs are scarce and valuable, so at the early stage of development, it doesn’t make sense to move to commercial scale until you have a full understanding of the critical quality attributes of the product and the production process on a small scale.
4. Manufactured in the USA
The pandemic has made many companies review their supply chain and manufacturing processes; where materials are made and where they are coming from can profoundly impact production.
Many of the companies who moved production offshore to reduce costs and increase efficiency are struggling to obtain APIs and key components or have experienced significant shipping delays, a paucity of raw materials and packaging components, and increased costs.
These companies are now looking to move their product development and manufacturing back to the United States to help eliminate the uncertainty in the delivery of key drugs that support the US market. US-based operations also offer greater access to FDA inspectors which can help speed up approvals.
Avéma Pharma Solutions and its parent company, PL Developments, made a commitment to US-based manufacturing long before the pandemic.
The company currently has nine manufacturing facilities across the United States and is actively adding more space and capabilities. Avéma’s newest facility in Miami, which will come online in October 2022, will add 135,000 sq. ft of manufacturing and R&D space.
5. Continuous investment
While pharma and biotech companies migrate to CDMOs to reduce their own capital investment, they expect their CDMO partners to continue to invest in their capabilities, their staff, their equipment, and their infrastructure.
It is critical for CDMOs to maintain staffing and to cross-train teams, so they are able to quickly respond to customer needs.
Avéma and PL Developments have a longstanding commitment to investing in their people, facilities and equipment. In the past few years, they have added additional granulation and encapsulation suites, purchased more analytical equipment, and added headcount in R&D and manufacturing. Avéma has also expanded its liquid manufacturing capabilities and added full on-site serialisation capabilities to its packaging lines.
Avéma Pharma Solutions and PL Developments bring decades of product development and commercialisation experience to the table. They have launched multiple OTC and Rx generic pharmaceuticals into the US and have also supported several international markets.
Together, they currently manage more than 30 CMOs for their own businesses and draw on this experience to make partnering with them the best experience for customers. Their goals are to become more than just an outsourcing vendor; they want to be close collaborators and long-term partners.