Development Strategies for Overcoming Commercialization Challenges

The company’s expertise in handling formulation, analytical methods, and packaging innovations underscores its role in enhancing drug stability and patient compliance. For emerging biopharma companies, choosing a contract research and development organization (CRDO) partner like Coriolis ensures a streamlined path to market, marked by rigorous science and strategic project management.

Essential Support Needs for Advanced Development Stages

As candidates advance from early to late development stages and near commercialization, the value of those assets and the time investment increase dramatically. While platform processes and methods can be applied during early-phase work, in later development stages, activities must be performed independent of previous efforts and using approaches tailored to the specific candidate.

Key activities in these later stages include final formulation adjustments, robustness testing of formulations, validation of scaled-down manufacturing process models, and comprehensive process characterization. This characterization covers essential operations, such as pumping, filtration, filling, mixing, thawing, and freezing. Additionally, process performance qualification (PPQ) at a large scale, selection of final primary and secondary packaging, stability studies, including forced-degradation tests, transportation and distribution simulations, and evaluation of real-world shipping conditions, are critical. Updating the clinical-use testing, which involves removing the product from its primary packaging for administration, is also integral to this phase.

While large, established biopharmaceutical companies possess extensive expertise and dedicated departments for these late phase to commercialization steps, smaller and emerging companies often encounter significant challenges. These include the complexity and high costs associated with these stages, which require specialized expertise to coordinate all activities and meet regulatory demands effectively.

To navigate these challenges, some smaller companies opt to license their technologies to bypass the hurdles of commercialization. Alternatively, partnering with an experienced contract services organization with a proven track record of guiding candidates through late-stage development to regulatory approval and market launch, offers a viable solution to ensure that crucial knowledge from early development stages is leveraged throughout the process, enhancing the efficiency and success of commercialization efforts.

Refining Analytical Practices for Late-Stage Trials

In early drug development, analytical method development is a foundational element that gains significance as candidates progress to late-stage clinical trials and commercialization. It’s imperative that methods for in-process monitoring, control, and final product release are not only validated but also supported with robust data. During late-phase development, critical quality attributes (CQAs) often undergo refinement, leading to narrower specification ranges. Additional formulation adjustments necessitate modifications in analytical methods for the late-phase to commercial stage, managed meticulously by quality control and quality assurance teams.

Moreover, proactive troubleshooting preparation is essential. The commercialization process invariably encounters unforeseen challenges. Being equipped with effective solutions and access to seasoned experts capable of addressing these issues is vital for maintaining project momentum and ensuring continuity.

Optimizing Packaging for Clinical and Commercial Phases

In the development of biological drugs, vials are typically used for early-phase clinical trials owing to their commonality and flexibility in dosing, which is crucial during dose-escalation studies. As products advance to late-stage trials and PPQ runs, defining the final primary packaging and container-closure systems becomes critical. These decisions should align with and be made in parallel to phase II study activities.

Frequently, transitions are made from a frozen or lyophilized product to a liquid or high-concentration formulation. Similarly, packaging may shift from vials to prefilled syringes or on-body injection devices. If these changes are not well-timed, they can lead to increased development time and costs, affecting both the pharmaceutical company and patient access to new medications. Accessing proven expertise in early decision-making regarding packaging can mitigate these risks, ensuring that transitions in drug packaging support both clinical and commercial timelines effectively.

Overcoming Viscosity Issues for Enhanced Drug Delivery

In the biopharmaceutical industry, the shift toward high-concentration formulations is driven by the need to facilitate self-administration of medications, which can reduce the necessity for hospital visits and hence the burden on the patient. These concentrated forms, while beneficial in reducing the volume of drug required per dose, introduce novel challenges, such as increased aggregation and potential degradation of biologic drugs.

To address these concerns, the manufacturing, storage, distribution, and usage phases must carefully manage these risks. Utilizing specialized excipients helps minimize adverse interactions that lead to aggregation or degradation. Furthermore, injection device design becomes crucial, as high-concentration products are more viscous, which requires careful container closure and device selection. The high-concentration development includes addressing issues like needle clogging and ensuring compatibility with syringe components like silicone and tungsten, which can affect product stability. Coriolis Pharma’s expertise in formulation, container closure, and device integration ensures that these complex factors are expertly managed to maintain drug stability and efficacy.

Ensuring Drug Stability Through Rigorous Testing

Stability studies are crucial to ensure patient safety by identifying potential degradation during storage and shipping that could lead to the formation of harmful contaminants. Late-phase development requires careful stability testing for thorough product understanding. These tests, necessary for addressing formulation changes from phase I through later development stages, include forced degradation under accelerated conditions, photodegradation, metal ion spiking, shaking, deamidation, oxidation, and other specific tests. Additionally, any compromised products are also tested for stability.

Partnering with a seasoned contract development and manufacturing organization (CDMO) that specializes in the design and implementation of these studies accelerates development programs and ensures adherence to stringent regulatory standards. Such partnerships leverage deep expertise in stability testing to optimize product safety and efficacy throughout the development life cycle.

Strategies for Post-Approval Drug Lifecycle Optimization

Post-approval life cycle management is essential for enhancing a product’s patient-friendliness and maximizing compliance. This often involves reformulating higher-concentration biologic products for home administration rather than hospital use or converting liquid formulations requiring low-temperature storage and shipping into lyophilized forms that do not have cold-chain requirements. These reformulation changes necessitate comprehensive stability, distribution, and clinical usage studies to ensure efficacy and safety. For smaller biopharma companies, partnering with an experienced CDMO like can be crucial in developing competitively advantageous products with prolonged market life, leveraging expertise in life cycle management to meet complex regulatory and market demands effectively.

Overcoming Obstacles in CDMO Transitions

Navigating the transition between service providers is a notable challenge in biopharmaceutical development. Companies often begin with CDMOs that specialize in early-phase activities and later switch to those capable of supporting larger-scale clinical and commercial production if the candidate advances to late-stage testing. This switch can be costly and time-consuming, risking the loss of crucial project information during the transfer.

The optimal approach to avoid this pitfall involves partnering with a comprehensive contract research and development organization (CRDO) like Coriolis Pharma. Such a partnership facilitates seamless development from the discovery stage through commercialization, covering both drug substance and drug product. By reducing the need for technology transfers between different CDMOs to a minimum, this approach ensures continuity and efficiency, leveraging all accumulated knowledge towards successful market entry. This integration significantly reduces time to market and development costs, providing a strategic advantage in the fast-paced competitive landscape.

Coriolis Pharma’s Full-Spectrum Development Expertise

Coriolis Pharma seamlessly integrates the entire spectrum of drug development, from candidate selection in the discovery phase through preclinical, clinical, and post-launch stages. Offering both non-GMP and GMP capabilities, Coriolis Pharma accelerates time to first-in-human studies and supports all clinical phase activities for drug substance and drug product development (e.g., process, analytical method, and formulation development). This includes a comprehensive range of services across lab to production scales, with a focus on phase-appropriate processes and method qualification/validation. In particular, integrating analytical methods and product development under one roof helps optimize efficiency and quality.

Our commitment to scientific rigor in formulation development and device selection is a key differentiator that underpins our consultancy services, ensuring tailored development strategies and effective project management. By fostering transparent communication with all involved stakeholders, Coriolis ensures that their projects benefit from an integrated approach, enhancing efficiency and maintaining high-quality standards throughout. The science-driven ethos is further strengthened by continuous investment in in-house research and a quality-by-design approach that embeds superior quality from the project’s inception.