Securing Reliable U.S. Supply of Complex Oral Solid Dose Manufacturing

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 OSD development, high-throughput clinical and commercial manufacturing capacity, and packaging services with full serialization capabilities. 

Contract Pharma: How does Bora optimize formulation development to facilitate scale-up from lab to clinical to commercial batches? What role does an integrated R&D program play in the success of this process?

Helen Clark: To facilitate long-term scale-up success, we keep scalability in mind from the earliest phases of development. Having an integrated R&D program within the full development and manufacturing continuum enables us to pursue in-depth work in early formulation development that will inform scalable processes and avoid the need for extensive reworking later. For Bora, an important component of this is the continuity of equipment across scales within our OSD facilities. We leverage the same brand of production equipment for lab-, clinical-, and commercial-scale batches, which provides a level of consistency and predictability in process development and validation as a program scales. 

Contract Pharma: What are the key challenges associated with solvent handling and manufacturing of controlled substances/HPAPIs? How does Bora address these challenges?

Helen Clark: Manufacturing controlled substances and HPAPIs presents significant challenges around operator safety, containment, regulatory compliance, and solvent management. CDMO facilities must prevent cross-contamination, control exposure to potent compounds, safely handle flammable or hazardous solvents, and maintain strict traceability and security requirements throughout production. These complexities can increase operational risk, slow production, and drive-up compliance costs. Bora addresses these challenges through advanced containment technologies, specialized solvent handling systems, robust environmental health and safety protocols, and deep expertise in regulatory compliance for both controlled substances and HPAPIs, enabling safe, efficient, and reliable manufacturing at commercial scale.

Contract Pharma: What is your approach for rapid, low-risk tech transfer?

Helen Clark: We approach tech transfer as a collaborative, strategic process rather than a handoff, helping support efficient, low-risk transitions. This depends on a few key pillars. First, a dedicated project management team is vital for guiding a successful tech transfer through from start to finish. This ensures continuity of knowledge, thorough communication, and alignment on expectations and timelines. Additionally, proactively anticipating challenges that may arise throughout the course of tech transfer helps to mitigate risk and avoid reworking later. For example, by applying a Quality by Design (QbD) framework to tech transfer and defining critical process parameters and quality attributes early on, we can build quality into the process from the start rather than try to work it in at the end. 

Contract Pharma: How does Bora manage raw material sourcing to ensure supply chain continuity? 

Helen Clark: As supply chains continue to evolve, part of ensuring production continuity is conducting supply chain planning in parallel with tech transfer activities rather than treating it as a final step. For commercial transfers, this includes aligning early on preferred suppliers and forecasting materials with long lead times at least six months in advance. During times of volatility or transition, we also consider strategic stockpiling of essential raw materials to avoid shortages or delays. 

Contract Pharma: How does Bora ensure seamless scale-up and consistent quality for high-potency APIs (HPAPIs), modified-release formulations, and other complex OSDs?

Helen Clark: One of our greatest advantages for supporting clients in complex OSD development and scale-up is our integrated formulation development service. Our team of experienced experts works with clients from the beginning of a program to understand the complexities of their product and develop robust formulations and scalable processes. This capability, paired with our HPAPI handling infrastructure and dedicated lab-scale and pilot-scale production facilities, enables Bora to confidently optimize manufacturing of even the most challenging OSD products.