Pharmaceutical companies advancing API programs from preclinical development into clinical trials and commercial manufacturing face technical and financial challenges. For emerging companies in particular, access to funding can determine how quickly a program advances and how development work is prioritized.

At the same time, an API process that works at laboratory scale may not translate directly to larger-scale manufacturing. Route optimization, impurity control, purification, yield, and process safety can become significant considerations as sponsors prepare to produce material for clinical studies.

These challenges make the selection of an API development and manufacturing partner an important decision early in a program. Olon USA will bring its perspective on these issues to AAPS PharmSci 360 in New Orleans, Louisiana, October 25–28, 2026, where pharmaceutical companies can meet with the Olon USA team at Booth 1338. AAPS PharmSci 360 brings together pharmaceutical scientists across preclinical and clinical development, bioanalytics, manufacturing and analytical characterization, and formulation and delivery.

CEO Robert Poe, Director of Business Development Nerissa Chu-A-Kong, and Business Development Manager Bea Ongwong will all be available to discuss the specifics of your program needs.

Funding Constraints Are Changing How Pharmaceutical Programs Advance

Funding remains a significant challenge for emerging pharmaceutical companies, particularly those working on preclinical and IND-enabling programs. Rather than receiving large amounts of capital at once, some companies are receiving funding in smaller increments and adjusting development activities accordingly.

This can create a challenge for sponsors that need to maintain development momentum while managing available capital.

Olon USA works with companies to provide greater flexibility around project planning and payment structures when appropriate. A sponsor may need to understand the budget for an entire preclinical-to-Phase I program while only having funding available for the next stage of work.

Structuring a program in defined stages can help sponsors understand the broader financial requirements while allowing development to proceed according to available funding.

For CDMO partnerships, flexibility can be as important as technical capability. Sponsors need partners that understand how funding affects development timelines, project scope, and manufacturing decisions.

Early API Process Development Can Determine Future Scalability

An API synthetic route that produces material successfully at the laboratory scale is not necessarily ready for API scale-up or kilogram-scale manufacturing.

As a program advances, the process may require optimization to maintain purity, control impurities, improve yield, and address manufacturing or safety considerations. Purification can become a particular concern. A laboratory process may rely on chromatography to remove impurities, but chromatography can result in significant API losses and become impractical or inefficient at larger scales.

Early API process development provides an opportunity to identify these issues before clinical manufacturing requirements increase. Olon USA has previously addressed how early API strategy can influence cost, scalability, material requirements, and long-term manufacturability.

Process development also provides an opportunity to prepare for API scale-up by identifying processing challenges before a program reaches larger manufacturing volumes. Olon USA’s scale-up approach evaluates synthetic routes for potential issues involving purification, hold times, filtration, polymorphism, phase separation, and other factors that can affect manufacturing performance.

Process Development Should Consider the Manufacturing Destination

Where API development is performed can influence the path to scale.

A process developed primarily to produce material quickly and economically may not have been designed for larger-scale manufacturing. When that process eventually moves toward clinical or commercial production, additional development work may be required to address scalability, purification, safety, or impurity control.

That can create additional cost and time requirements. In some cases, changing the manufacturing process later can also introduce additional considerations for the development program.

A process designed with future manufacturing requirements in mind can provide a more direct path toward scale-up.

Olon USA approaches process development with scalability in mind from the beginning. Synthetic chemistry, process chemistry, and chemical engineering teams consider how a process can transition from milligram and gram quantities to larger manufacturing scales.

Process understanding can also be strengthened through tools such as Process Analytical Technology (PAT), which can provide real-time insight into reaction progression and crystallization behavior during development and scale-up.

Communication Is a Critical Part of CDMO Partnerships

Technical capabilities are only one consideration when selecting an API development and manufacturing partner.

Development and manufacturing programs rarely progress without unexpected challenges. A process may behave differently at a larger scale, an impurity may require additional investigation, or a manufacturing step may require modification.

The response to those challenges can have a direct impact on the project.

Olon USA emphasizes a collaborative approach to problem-solving. Rather than simply communicating that an issue has occurred, the team works to identify potential solutions, discuss the available options with the sponsor, and establish a path forward together.

That approach becomes increasingly important as programs move from early development into clinical manufacturing and eventually toward commercialization.

For sponsors looking to reduce development risk, early coordination across chemistry, process development, analytical, and manufacturing teams can help identify potential issues before they become larger obstacles.

A Global API Network with U.S. Manufacturing Capabilities

Olon provides pharmaceutical companies with access to a global network of API development and manufacturing sites. This allows projects to take advantage of specific technical capabilities across the network while maintaining continuity between development and manufacturing activities.

For sponsors seeking U.S.-based API manufacturing, the network can also provide options for managing the overall manufacturing process.

Certain intermediates can be produced at Olon facilities outside the United States before later manufacturing steps are completed at Olon USA when appropriate. This approach can help sponsors balance technical requirements, manufacturing location, and cost considerations while maintaining access to capabilities across the Olon network.

Olon USA’s expanding U.S. manufacturing capabilities support both clinical and commercial programs, providing sponsors with additional options as projects progress through development.

AAPS PharmSci 360 Offers an Opportunity to Discuss the Next Stage of API Development

AAPS PharmSci 360 brings together pharmaceutical scientists from academia, industry, government, and related organizations to discuss developments across the pharmaceutical sciences. The 2026 program includes tracks covering preclinical, clinical and translational science; bioanalytics; manufacturing and analytical characterization; and formulation and delivery.

For Olon USA, the event provides an opportunity to discuss the practical challenges sponsors face as API programs advance. Conversations will include how companies are managing available funding, planning development activities, and preparing molecules for clinical trials and later-stage manufacturing.

Olon USA will also be available to discuss programs that require specialized chemistry, process development, scale-up, or manufacturing support across the Olon global network.

Meet Olon USA at AAPS PharmSci 360

For pharmaceutical companies developing small-molecule APIs, the decisions made during early development can influence scalability, manufacturing efficiency, cost, and the path toward commercialization.

Olon USA provides process development and API manufacturing capabilities supported by a global network of specialized facilities and a collaborative approach to solving development and manufacturing challenges.

Attendees at AAPS PharmSci 360, October 25–28, 2026, in New Orleans, can meet the Olon USA team at Booth 1338 to discuss an API development or manufacturing program, upcoming clinical requirements, or strategies for advancing a project toward commercial production.

Contact Olon USA to start a conversation about the technical, manufacturing, and development requirements for the next stage of your API program.