Pharmaceutical Regulatory Affairs: Open Access

Mycobacteria, though predominantly known for their role in causing infectious diseases, can also pose significant challenges in biopharmaceutical manufacturing. Traditional microbiological methods often struggle to detect Non-Tuberculous Mycobacteria (NTM) due to their slow growth and unique characteristics. As a result, alternative detection techniques have gained importance in ensuring the safety and quality of biopharmaceutical products. This article explores various non-microbiological mycobacterial detection techniques employed in biopharmaceutical manufacturing, including molecular methods, mass spectrometry and advanced imaging technologies. By leveraging these innovative approaches, biopharmaceutical companies can enhance their ability to detect mycobacterial contamination, thereby mitigating risks and upholding product integrity.

Antibody production holds immense promise for addressing a plethora of health challenges, from combating infectious diseases to treating cancer. The scalability of production processes is crucial to meet the growing demand for these biopharmaceuticals. Stirred bioreactors are central to this endeavor, offering flexibility and efficiency. However, the scalability of antibody production in stirred bioreactors can be influenced by their geometries. This article explores innovative approaches to scaling antibody production in stirred bioreactors with differing geometries. It examines strategies such as advanced mixing techniques, optimization of mass transfer and novel reactor designs. These approaches aim to enhance productivity, improve process control and streamline manufacturing, ultimately advancing the accessibility of life-saving antibody therapies.

Mucosal vaccination presents a promising avenue for enhancing immune responses against pathogens, particularly those that enter the body through mucosal surfaces. However, the development of effective mucosal vaccines faces numerous challenges, including antigen stability, delivery efficiency and immune stimulation. In recent years, Polymeric Caffeic Acid (PCA) has emerged as a novel antigen carrier with remarkable potential for mucosal vaccine applications. PCA, derived from natural sources, offers several advantages, including biocompatibility, biodegradability and immunomodulatory properties. This article provides an overview of the recent advances in utilizing PCA as an antigen carrier for mucosal vaccines, highlighting its unique properties, formulation strategies and potential applications in combating infectious diseases.

Oleanolic acid, a naturally occurring triterpenoid compound, has gained significant attention in recent years for its potential therapeutic properties. However, its poor aqueous solubility and low bioavailability pose challenges for its effective utilization in various applications, including pharmaceuticals, cosmetics and nutraceuticals. In this article, we explore innovative delivery methods aimed at overcoming these challenges and enhancing the bioavailability and efficacy of oleanolic acid. These methods encompass nanotechnology-based approaches, lipidbased formulations and encapsulation techniques, which offer promising strategies for enhancing the solubility, stability and targeted delivery of oleanolic acid. By harnessing these innovative delivery methods, researchers and industries can unlock the full potential of oleanolic acid, paving the way for its broader utilization in diverse therapeutic and cosmetic applications.