Advanced OSD Manufacturing

Post Date: March 4, 2024
Written By: Tedor Pharma Services

Solving the Challenges of Advanced OSD Pharmaceutical Manufacturing

Small-molecule oral solid dosage (OSD) forms continue to be the dominant drug delivery format within the pharmaceutical manufacturing industry. However, with new technologies and drug-delivery advancements constantly entering the market, experience with difficult-to-manufacture products is more important than ever. Successfully producing advanced OSD therapeutics requires manufacturers with technical expertise and manufacturing experience to address solubility, variability, and potency challenges, as well as skill with modified-release formulations.

The OSD Pharmaceutical Manufacturing Landscape

Innovators have increasingly turned to OSD contract development and manufacturing organizations (CDMOs), fully equipped with wet granulation, dry granulation, compression, particle coating, spraying, and other unit operations, for their drug product manufacturing experience, capacity, and knowledge of regulatory requirements. In fact, a recent Future Market Insights report forecasted that the global small molecule CDMO market will achieve a 5.2% CAGR over the next ten years (2024 – 2034). Advanced OSD dosage forms will undoubtedly play a central role in this growth.

Because advanced OSD forms, such as high-potency API (HPAPI) and modified release (MR), pose unique challenges with bioavailability, solubility, and variability, choosing a CDMO with the needed expertise is critically important.

HPAPIs and the Next Generation of OSD Manufacturing

HPAPIs are active at low doses, and they have tremendous pharmaceutical potential because of their ability to target precise disease cells, including cancer cells. Today, the global impact of HPAPIs is immense. Over 25% of drugs in the global market are classified as highly potent, and the global annual revenue of HPAPI drugs is expected to reach $40 billion by 2025.

However, HPAPIs typically pose significant manufacturing challenges. Their high potency presents considerable environmental risks to workers, thus demanding rigorous safety protocols. When handling HPAPIs, CDMOs first assess the Occupational Exposure Limit (OEL) to classify it as high potency. Then, CDMOs must have the required analytical tools, isolation systems, and manufacturing equipment. Staff must have proper training and certifications to develop risk assessment procedures and ensure safety, quality, and compliance at every step of manufacture.

Achieving Bioavailability for Poorly Soluble & Highly Variable APls

Solubility and variability are preeminent issues in OSD manufacturing, as nearly half of all currently marketed drug products today meet the Biopharmaceutical Classification System (BCS) definition of poorly soluble (classes II and IV). Both solubility and variability directly impede the bioavailability of an API, complicating the path to the development and manufacture of an efficacious drug, not to mention the regulatory approval process.

Experienced CDMOs have many tools to address bioavailability and help minimize manufacturing challenges down the road. Specifically, they have the right teams and experience to fully understand a product’s physicochemical (PC) characteristics and then leverage that information to solve solubility and variability challenges early in process development.

Release Delivery Solutions: Modified Release OSD Manufacturing

Modifying the release of API in OSD products to control the time or site of release has been an area of significant innovation in recent years. MR drug products, including extended-release, controlled-release, and immediate-release formulations, have yielded tremendous benefits such as improved efficacy, reduced side effects, and patient compliance.

Because formulation, process development, and manufacturing must integrate for successful MR therapeutic production, a one-stop CDMO is ideal. With all the needed expertise and capabilities under one roof, these teams can seamlessly collaborate, avoiding costly, time-consuming, and sometimes risky tech transfer processes.

Meeting the Challenge of Advanced OSD Products

When facing the challenges of difficult-to-manufacture OSD products, Tedor Pharma Services provides the technical expertise and flexibility necessary to produce and bring the drug to market. Tedor Pharma Services is a reliable, US-based contract manufacturing partner with decades of industry knowledge and specializes in manufacturing HPAPIs, poorly soluble, highly variable APIs, modified release products, and other advanced solid-dose drug products.

Founded in 2001, Tedor is headquartered in Cumberland, Rhode Island, and our OSD processing and manufacturing capabilities make us a one-stop CDMO. By putting customer communication first and implementing a comprehensive Quality by Design (QbD) milestone-based project management process, Tedor Pharma meets advanced OSD manufacturing challenges head-on, allowing us to serve as a trusted and valuable partner for our clients.

Get in touch with our team today, and let us show you how we combine technical expertise with a commitment to customer success in manufacturing HPAPIs and advanced OSD products.