Introduction

Oral Solid Dosage (OSD) drug formulations are the cornerstone of modern pharmaceuticals, making up a significant percentage of medications available today. Their ease of administration and storage stability has propelled OSD technologies into the spotlight. As we advance into an era of personalized medicine, the push for innovative solutions that enable the oral delivery of traditionally challenging molecules like peptides, proteins, oligonucleotides, enzymes, and monoclonal antibodies is becoming more pronounced.

To dive deeper into these exciting developments, we spoke with Anil Kane, the Executive Director and Global Head of Technical & Scientific Affairs at Thermo Fisher Scientific. The company has made substantial investments in expanding its OSD capabilities, committing $22 million since 2021 to enhance its services and technology.

Emerging Trends in OSD Formulations: What to Watch For!

The demand for OSD project services is skyrocketing, with Contract Development and Manufacturing Organizations (CDMOs) stepping up to provide essential services such as formulation support, analytical testing, and clinical supply chain management. Change is in the air, as pharmaceutical companies shift from traditional trial-and-error methods to innovative predictive modeling techniques. Leveraging next-generation technologies like Artificial Intelligence (AI) and Machine Learning (ML) is revolutionizing how formulators assess broader formulations, thus enhancing bioavailability and solubility with unprecedented precision.

Complex Challenges: The Future of OSD and Its Molecular Mechanics

In the past decade, Thermo Fisher Scientific has facilitated the approval of 125 new OSD drugs, and this rapid pace shows no signs of abating. Companies are increasingly interested in the oral delivery of large molecules while also navigating the complexities of small molecules and intricate dosage forms.

One of the most pressing challenges in small molecule development is poor solubility and bioavailability, which leads to increasingly sophisticated formulations. As drug candidates advance from discovery stages to clinical trials, it is imperative to quickly evaluate their properties to improve efficacy and target delivery without compromising quality.

Revolutionizing Manufacturing Processes with Continuous Innovation

Continuous manufacturing is making significant strides, solidified as a commercial technique over ten years ago but continually gaining traction. Companies are now integrating continuous processes earlier in their development cycles, taking advantage of Industry 4.0's promise of automation and software enhancements. The integration of AI and ML into OSD formulation is accelerating development timelines, minimizing risks, and empowering formulators to make informed decisions regarding excipients and solubility.

Thermo Fisher's Expansion: A Game-Changer for OSD Capabilities!

Thermo Fisher Scientific's latest OSD expansion aligns with the growing global demand for oral solid formulations. Producing approximately 4.2 billion tablets and capsules annually, the company is strategically enhancing its production capabilities with new facilities in Bend, Oregon, and Cincinnati, Ohio. These expansions aim to make pre-clinical oral drug development more efficient, ultimately reducing the timeline to Good Manufacturing Practice (GMP) production of clinical trial materials.

The Bend facility will now encompass 29,000 square feet, doubling its available space and allowing for more advanced drug delivery solutions focused on solubility and bioavailability enhancements. It also brings state-of-the-art features such as energy-efficient fume hoods that align with sustainability goals.

In Cincinnati, the new 3,200-square-foot non-GMP research and development space is equipped with cutting-edge technology aimed at facilitating OSD formulation development, including a pilot-scale high-shear granulation and fluid bed processing suite.

Conclusion

As the landscape of oral solid dosage continues to evolve, stakeholders can expect increasingly tailored approaches that blend science, technology, and innovative thinking to meet the demands of modern healthcare—potentially transforming patient outcomes worldwide! Stay tuned for more breakthroughs that could redefine drug administration in the near future.