Optimizing Pharmaceutical API Processes
Explore how our systemic approach to API processes yielded close to 100% reduction of API content variation and a reduction of batch scrap rate from 40% to 10%.
Good stories
Having a promising drug candidate is not always enough. Emendo R&D was brought on board when a Nordic pharmaceutical company faced the challenge of developing and later managing the procurement and development of a new user-friendly injection device.
INTRODUCING
Combination products present unique challenges in development, commercialization, and regulatory compliance, as they require adherence to multiple sets of guidelines governing both drug and device components.
Listen as our Scientific Senior Consultant, Tanguy Floch, covers some of the challenges associated with developing and managing a complex combination product and how to avoid costly mistakes.
THE CHALLENGE
Handling combination products can be challenging for pharmaceutical companies, especially when working with medical device components. A Nordic company faced this challenge while developing an injection device for a promising drug candidate. They lacked experience in medical device development, creating a significant knowledge gap. To bridge this gap, they turned to Emendo R&D — drawing on our experience in Early Technology and Device Innovation to support early-stage device development and ensure strategic alignment from the start.
OUR APPROACH
The team took on the primary challenge of bridging the knowledge gap and successfully assisted in the development of a pre-filled autoinjector that would enable patients to self-administer their medication without external assistance. In addition, Emendo R&D navigated the complex landscape of regulatory requirements and procurement practices for injection devices, which added another layer of complexity to the project.
Emendo R&D conducted workshops to educate the client on medical device development methodologies and combination product complexities. They defined design requirements and assessed user risks. As the project progressed, tasks expanded to include supplier selection and project outsourcing management.
Emendo R&D was hired to align customer requirements with potential device suppliers, developing a comprehensive Request for Proposals (RfP), and coordinating with suppliers to ensure high quality proposals. Furthermore, the team was tasked with streamlining supplier communication for efficiency and transparency, obtaining accurate proposals to eliminate potential surprises later in the project, as well as leveraging multiple proposals to compare prices and negotiate cost savings for both project development and future production.
Emendo R&D expanded tasks to include providing inputs into the contract, aligning project plans, and project coordination. They identified and mapped required studies. Emendo also worked with the CMO to refine device specifications and align them with syringe specifications. They supported technical troubleshooting and reviewed design control documentation provided by the CMO.
THE RESULTS
The guidance and hands-on management from Emendo R&D throughout the project led to the successful development of a combination product: a prefilled, user-friendly autoinjector. By successfully bridging the gap between pharmaceutical and medical device development, Emendo R&D achieved cost savings while ensuring compliance with regulatory standards.
During the project, Emendo R&D managed:
After successfully managing a combination product project for a Nordic pharmaceutical company, we bridged knowledge gaps, oversaw supplier selection, and ensured cost savings and regulatory compliance throughout.
Contact Hanne Everland, Vice President at Emendo Research & Development, if you’re looking to implement a similar approach.
Explore how our systemic approach to API processes yielded close to 100% reduction of API content variation and a reduction of batch scrap rate from 40% to 10%.
Explore how we supported a pharmaceutical startup meet regulatory requirements when taking their product from research to development.
Discover how we implemented a new analytical test method to ensure the quality and safe use of a novel drug substance for clinical trial material.
HAVE A QUESTION
A pharmaceutical combination product integrates a drug, device, or biologic component into a single product. Examples include prefilled syringes, autoinjectors, or inhalers. These products require development and regulatory compliance that address both the drug and medical device elements, following specific guidelines from authorities such as the FDA or EMA.
Common challenges include managing dual regulatory pathways (for both drug and device), defining design requirements, ensuring usability and patient safety, coordinating suppliers, and aligning pharmaceutical processes with medical device manufacturing standards.
Supplier selection is vital because it affects device quality, compliance, production costs, and timelines. Choosing the right contract manufacturing organization (CMO) ensures reliable development, cost savings, and smoother regulatory approval. Developing structured RfPs and comparing supplier proposals is essential for informed decision-making.
Effective outsourcing management involves aligning project plans, mapping required studies, refining technical specifications, overseeing contract negotiations, and ensuring design control compliance. Close coordination with the CMO helps maintain quality standards while optimizing development costs.
Through structured supplier selection, contract negotiation, and process optimization, pharmaceutical companies can reduce fixed project costs and unit production costs. In the highlighted case, Emendo R&D achieved 10% savings in fixed costs and 5% savings in unit costs for future production runs.