In an increasingly complex pharmaceutical landscape, companies face significant challenges in bringing their products from development to market efficiently and seamlessly. The fragmentation of CDMO services, lack of integration between development and manufacturing, and uncertainties in cost and technical feasibility often lead to delays, increased risks, and higher expenses. How can pharmaceutical companies secure a streamlined, reliable, and cost-effective pathway from early development to commercial production?

This webinar aims to answer that question by presenting Fareva’s unique approach as an end-to-end CDMO. With a fully integrated offer, Fareva eliminates the traditional hurdles of fragmented outsourcing by ensuring a seamless transition from pharmaceutical development to industrial-scale manufacturing. Our three GMP pilot sites support product development and technical transfers across fifteen manufacturing facilities, providing a structured and predictable process for our clients. By aligning development and manufacturing from the outset, we simplify project management with a single point of contact, ensure cost visibility, and accelerate time-to-market.

The session will also highlight Fareva’s specialized expertise in high-potency oral solid doses, sterile manufacturing, and biologics, demonstrating how our tailored solutions can support even the most complex pharmaceutical developments. We will explore real-world examples, including how we successfully transferred an mRNA vaccine in record time, overcoming major technical challenges with speed and precision.

Through this presentation, you will gain a clearer understanding of how working with a development-driven CDMO can mitigate risks, optimize resources, and ensure a successful pathway to commercialization.

As the need for large-volume delivery grows, so does the need to standardize primary containers in the OBDS world. As such, we know that we must partner transparently and seamlessly with members of the ‘primary container ecosystem’ to help define the standard.

Grand River Aseptic Manufacturing and LTS Device Technologies understand the paradoxical need for standardization and flexibility. Yet, we ask ourselves, is the standardization of large-volume primary containers and components on the horizon?

The innovator drug products above 5 mL are coming, and several on-body-based drug products will lose exclusivity over the coming 2-10 years. Subsequent biosimilar launches will rely heavily on large volume OBDS to maintain or exceed the patient experience of the innovator product. With impending demand, we can’t sit around and wait for the world to tell us what standard is, so we must create it.

You will leave the session with an understanding of: 

• • The criticality of CDMOs and drug delivery device innovators collaborating
• • The benefits of standardized offerings of large-volume primary containers and components 
• • How to eliminate extra investments and timeline extensions for unique primary containers 
• • And more! 

An optimal formulation is the simplest option that meets the product and patient’s needs. A technology agnostic approach based on a fundamental understanding of API properties, a well-defined yet flexible target product profile, and a mindset for scalability and commercial relevance leads to success in formulation development and drug product design.

In the modern landscape for oral dosage forms, enabled formulations for bioavailability enhancement are increasingly common. Drug candidates are no longer ruled out in discovery due to low solubility or low permeability, allowing for more explicit optimization of molecular properties that drive safety and efficacy while relying on formulation and delivery technologies to overcome the barriers associated with limited oral absorption. A developability assessment to determine the most appropriate technology should take into consideration molecular properties of the API, bio-performance modeling to predict absorption as a function of form and formulation, and a comprehensive understanding of the patient population, product design, and program strategy.

In this webinar, we’ll discuss how to use this approach to strategically guide formulation technology selection. When an enabled formulation is required, we’ll discuss how these same tools can further help to guide formulation development and product design.