Why the right partnerships are key to harnessing new sterile delivery methods

Why the right partnerships are key to harnessing new sterile delivery methods

The pharmaceutical industry is facing a transformative era, largely driven by the emergence of innovative sterile drug delivery methods required to administer biologics and other complex drugs.

These new technologies, including pre-filled syringes, wearable injectors and implantable drug delivery systems, hold the potential to revolutionize patient care by enhancing convenience, compliance and therapeutic outcomes. However, their successful implementation hinges on overcoming a wide range of challenges, spanning regulatory requirements, costs, complexity and patient acceptance hurdles.

As a result, strategic partnerships with contract development and manufacturing organizations (CDMOs) are proving essential for pharmaceutical companies seeking to harness the full potential of their innovative drug products. But finding the right CDMO partner with the experience, capabilities and capacity to meet each drug product’s unique needs is not always an easy feat.

Understanding the challenges

New sterile drug delivery methods — in combination with the formulation they are designed to support — require extensive testing and validation to demonstrate their efficacy and safety. They also require the pharmaceutical companies that develop them to secure regulatory approval across each of their key target markets.

Wearables and implantables are complex innovations, requiring specialized equipment and expertise to produce and bring to market. Some patients may also be hesitant to try unfamiliar new devices and technologies. Without the right support in place to streamline their adoption, low patient acceptance and compliance may result.

Despite these challenges, the shift toward innovative drug delivery methods within the sterile drug product sector is expected to continue. As these technologies advance and secure regulatory clearance, they stand ready to reshape the administration of sterile medications, ultimately elevating patient care and overall well-being. Companies must look to their outsourcing partners to ensure they can overcome these challenges.

Finding the right CDMO partner

CDMOs play an essential role when it comes to bringing complex drug products to market. The right partner will bring a wealth of specialized knowledge and resources to the table, enabling pharmaceutical companies to navigate the intricacies of development and commercialization with confidence.

By leveraging the expertise of CDMOs, companies can expedite their time to market, reduce costs and mitigate risks.

So, how can companies ensure they’ve found the right CDMO partner? This is a critical decision that can significantly impact the success of a sterile drug product.

Key considerations include:

• Aseptic processing expertise
• Specialist infrastructure
• Biologics capabilities
• Sterilization expertise
• Validation expertise
• Analytical testing capabilities.

A CDMO with a proven track record in these areas can provide invaluable support throughout the product life cycle.

How can Alcami support you?

Having served pharmaceutical and biotech companies of all sizes, Alcami has spent 45+ years providing customizable solutions for:

• Analytical development
• Clinical to commercial sterile and oral solid manufacturing
• Microbiology
• cGMP pharma storage
• Calibration
• Validation
• Environmental monitoring services.

We have also facilitated regulatory approvals in over 40 countries and supported over 500 IND filings, with over 950 customers supported in 2023 alone.

As a US-based CDMO, we follow a rigorous safety and IP regulatory regime to meet global regulatory agencies’ strict regulatory requirements.  This enables us to provide peace of mind for our customers planning to commercialize their drug products in the US.

Learn more about how our drug product manufacturing capabilities make us the ideal CDMO partner to help bring your innovation to market:

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Interested in developing a pre-filled syringe product? We have the capabilities and capacity to support your project.