The rising incidence of ocular diseases around the world has fostered significant research and development over the last few years, with several advancements moving ophthalmic drug delivery into an exciting new phase. The potential of these advancements, however, is matched by the complexity of developing and delivering these new, promising therapies.
Pharmaceutical companies are increasingly partnering with Contract Development and Manufacturing Organizations (CDMOs) to meet these evolving demands. In fact, the fast-growing CDMO market is projected to reach $309.5 billion (USD) by 2028.
In this blog post, we’ll look at the benefits of working with a CDMO ophthalmic drug development and what you should look for when searching for the right partner.
Leveraging Innovative Formulations to Transform Ophthalmic Drug Delivery
As we discussed in a recent blog post, there are unique challenges for drug delivery to the eye. To start, it has several anatomical barriers that limit how much medication reaches its target site, including the outer layer of the cornea, the conjunctiva, and the blood-aqueous and blood-retinal barriers. These barriers repel water-based medications, hinder drug absorption, and strictly control what substances enter the inner eye.
Making matters worse, the eye then has another set of natural defense mechanisms, including rapid tear film turnover, which constantly washes away medication. As you can imagine, these barriers can severely impact treatment and patient adherence.
Polymer- and lipid-based nanocarriers are one of the most exciting advances in ocular disease treatment, and they offer significant potential in overcoming these barriers. As microscopic platforms, nanocarriers have been shown to:
- Deliver higher concentrations of medication directly to the target site, bypassing anatomical barriers.
- Minimize unwanted systemic exposure.
- Slowly release medication over time, overcoming tear film turnover and improving drug residence time.
- Target delivery to address specific ocular conditions, maximizing therapeutic effect.
Developing and applying these technologies, however, can be complex, and this has encouraged companies to seek out strategic partnerships that can provide support and complement internal resources and expertise.
The Benefits of Partnering with a CDMO for Ophthalmic Formulation Development
Partnering with a CDMO specialized in ophthalmic formulation development can offer a multitude of benefits, including:
How to Choose a CDMO Partner for Ophthalmic Drug Delivery
There are a number of key considerations you should keep in mind when selecting a CDMO for your ophthalmic drug delivery projects, including:
- Expertise and scaling capability
Complex chemistry challenges often arise. CDMOs with a wide range of expertise and specializations can help you overcome these challenges in innovative ways, often opening up new opportunities. To better understand a CDMO’s scientific expertise, take the time to explore the depth of knowledge of their leadership team. CDMOs that are most effective for the future of ophthalmic drug delivery, for example, should have extensive experience with polymers, nanoparticles, and enzymatic cleavage.
It’s also important to ensure the CDMO has a demonstrated ability to transition from small-scale milligrams to large-scale kilograms. The ability to scale quickly in the same facility is an important factor for efficient and effective production at different stages of drug development – and to enable your growth.
- Trustworthiness and reliability
Effective CDMOs also utilize early GxP capabilities for pharmaceutical production, ensuring quality, compliance, and reliability throughout the drug development process.
Evaluate any prospective CDMO's track record, certifications, industry accolades, and client testimonials to gauge their standards and ability to consistently deliver high-quality results. The best CDMOs prioritize problem-solving and tailored solutions over generic chemical compound delivery.
- Where are they located?
The location of a partner can have a significant impact on the success of your collaboration. If you are in North America, for example, working with a North American CDMO can simplify real-time communication, reduce lead times for project deliverables, and provide a secure, reliable source for pharmaceutical materials.
A North American CDMO would also adhere to stringent regulatory standards, providing robust intellectual property (IP) protection and ensuring full compliance with regulatory requirements in pharmaceutical development.
- Flexibility and agility
Look out for CDMOs that are customer-centric, lean, and agile in their operations. They should demonstrate urgency, quick turnaround times, and a collaborative approach to meet tight timelines and adapt to evolving project needs.
- Forward-thinking leadership
Look for CDMOs with forward-thinking leadership that are relentless pursuers of innovation. Are they, for example, consistently investing in advanced technology and state-of-the-art facilities?
Working with forward-thinking CDMOs provides access to adaptable, advanced manufacturing processes and cost-effective production methods and facilities, such as cutting-edge R&D labs, fully-equipped kilo labs and scale-up suites, pilot plants, class 6 cleanrooms, and advanced analytical instrumentation.
GLC: Your Trusted CDMO Partner
GL CHEMTEC is passionate about your success and committed to solving your most complex chemistry challenges. With our expertise in small molecule API development and tailored biomedical polymers, we offer fast, flexible, cutting-edge solutions. Our commitment to a collaborative partnership means we scale and adapt precisely to meet your evolving needs.
GL CHEMTEC provides:
- A unique combination of expertise in small molecule and biomedical polymers tailored to the target
- Integrated solutions that accelerate early-stage API development and innovative drug delivery solutions, with seamless continuity from R&D to manufacturing
- Strong organic polymer expertise and advanced biomedical materials applied to medical devices, drug delivery, and ophthalmic applications
- Unmatched expertise in polymer design and development, including tailored polymers, hydrogels, films, and emulsions/nano-emulsions
- Advanced custom hydrogels and silicone hydrogels for drug delivery through the eye
- North American facilities, offering a reliable alternative to overseas supply chains and partners
- A highly customer-centric culture and a 22-year track record of success
- ISO 9001:2015 and ISO 13485:2016 certifications