Managing Manufacturing in Times of Uncertainty
Virtual pharmaceutical companies often have strong regulatory and clinical teams, but lack the resources needed to address the complexities of the complete product development and commercialization cycle. Partnering with a contract development and manufacturing organization (CDMO) is a proven solution, particularly when selling into multinational markets or working with new combination pharmaceuticals.
Keys to success include building trust, engaging in proactive business continuity planning, mitigating supply chain risk, and committing to ongoing relationship management. Leading pharmaceutical companies recognize the value of working with a respected global CDMO leader like CMIC.
A panel of experts from Otsuka, Calliditas Therapeutics, Masters Speciality Pharma, and Eisai joined leaders from CMIC Group in a virtual roundtable discussion. These pharmaceutical professionals explored key aspects of evaluating contract manufacturing vendors, building strong partnerships, and related considerations.
Virtual pharmaceutical companies need CDMO partners that can offer expertise, support, and guidance throughout the product life cycle.
Trust and developing a true partnership are critical aspects of successful CDMO relationships. Based on their experience, the panel shared the most important considerations for virtual pharma companies when evaluating a CDMO:
- Total support and expertise throughout the product life cycle. When a CDMO works with small virtual companies, it must analyze the entire development process to identify challenges associated with scaling up and moving to the commercial stage. For example, some APIs have difficult release, due to either poor solubility or poor absorption. CMIC has taken unique measures to address these issues for clients. The company also evaluates whether the commercial sites can manufacture products efficiently, cost effectively, and reliably.
- A commitment to quality by design. Quality by design in R&D and small-scale stages of development saves money and reduces regulatory approval times by months. This means commercial launches can happen sooner.
- Clearly defined processes. Efficient tech transfer processes are essential, since that can be a limiting step. When Masters Speciality Pharma evaluates CDMOs, for example, they look for clear guidelines and Gantt charts that outline schedules. John Iwasyk recommends seeking partners with comprehensive business continuity plans.
Virtual pharma companies may want to adopt these four best practices when selecting and working with a CDMO:
- Create a set of requirements for the relationship.
- Develop a list of questions for the CDMO team in each functional area
- Identify whether the CDMO team has the right skills and experience base
- Continue with ongoing relationship management after selecting a partner