Unlike standard immediate-release tableting, complex oral solid manufacturing requires specialized infrastructure and engineering. Securing a reliable U.S. domestic supply for complex oral solid dosage (OSD) manufacturing is of the utmost importance for pharmaceutical companies looking to mitigate global supply chain disruptions and manage advanced drug delivery technologies.

To build a secure U.S. supply chain for complex OSD drug products, sponsors look to CDMO partners like Bora Pharmaceuticals with specialized domestic facilities equipped to handle complex processing, manufacturing controlled substances and solvent handling, as well as R&D scale up and tech transfer to commercial scale.

Helen Clark, Head of Global MSAT, Bora Pharmaceuticals shares insight on the capabilities needed to produce complex OSD drug products from the earliest stages of development to rapid, low-risk tech transfer and seamless scale-up.

Contract Pharma: What manufacturing technologies, services, and processes set Bora’s capabilities apart for developing and producing complex oral solid dose (OSD) products?

Helen Clark: We set ourselves apart in the complex OSD space through the breadth and depth of our OSD capabilities. Our teams are highly skilled in producing both tablets (coated, matrix, bi-layered, and mini-tablets) and capsules (combination fillings with up to three components such as powders or micro-particles in a single capsule) using various delivery technologies (sustained-, pulsed-, modified-, and delayed-release). Bora’s established solvent handling and containment capabilities for controlled substances and highly potent APIs (HPAPIs) further extend our offerings. In addition to working across a diverse range of OSD technologies and categories, we provide true end-to-end support for our partners. This includes dedicated R&D facilities for…