In the biotech industry today, mergers, acquisitions, and joint ventures are announced daily. Startup companies with viable molecules must decide early how they get a drug into trials, and eventually to the marketplace, as rapidly as possible. Contract research organizations (CROs), contract development and manufacturing companies (CDMOs), and dedicated contract manufacturing organizations (CMOs) all offer options for the specific expertise needed to complete the research, product development, and process development necessary to successfully manufacture a new drug entity.
Picking the right partner and approach is essential and is unique to each organization. No startup can do everything internally, so the following major decisions must be made:
1) Finance – Go it alone or partner with a large pharma/biotech company for expertise and funding
2) R&D – Outsource research or hire process development in-house
3) Quality – Hire a quality organization or use an experienced consulting firm for advice
4) Manufacture – Long-term supply chain planning, when to use a CMO, and when to build
5) Due Diligence – Are facilities your partner is proposing viable from an engineering, quality, and regulatory perspective?
Picking the right partner or purchasing an existing facility can allow for rapid manufacturing ramp up or additional capacity when the facility is operational, fit for use, and compliant with the relevant regulations. On the other hand, numerous large manufacturing companies have recently received Complete Response Letters (CRLs) delaying launches of major drug candidates for manufacturing regulatory compliance issues. While any delay is detrimental to any firm’s bottom line; it could be catastrophic to a small company launching their initial product. Having an experienced partner with expertise in capital projects, manufacturing, and supply chain management can ease these worries through auditing and providing the necessary oversight to verify your partners perform at the level promised.
Building a small, modular facility offers the opportunity for owner flexibility to quickly modify the process during startup, product exclusivity, and continuous access as well as control over the facility maintenance and regulatory compliance. These facilities can be delivered using state of the art project management and design techniques in a year or less. Using a risk-based approach, major capital expenditure can be delayed until preliminary clinical trial results are positive and the market conditions are known.
Quality at the right level is a critical component to a growing organization. Too many detailed quality procedures suitable for a large multinational pharmaceutical manufacturer could suffocate the emerging organization by burying it in “red tape” at the time it needs maximum flexibility. However, too little quality could create a culture that is resistant to change when precise documentation of risks and decision making is critical. Outsourcing this function to an organization experienced in delivering quality from a business perspective allows your team to focus on their core competencies while giving you the confidence that a quality culture is being inculcated into the organization and the critical FDA approval will not be delayed with quality concerns.
Documenting the science behind your molecule and process development throughout the R&D process is an integral part of a successful New Drug Application (NDA). Having items such as Critical Quality Attributes (CQAs), Key Process Parameters (KPPs), Process User Requirements, Design Controls, and an overall quality risk management approach documented clarifies the design philosophy, allowing for rapid design and build of a manufacturing facility or selection of the appropriate CMO.
A trusted partner firm with solid processes, quality system procedures, and experienced consultants can be invaluable in supporting your organization during early development. Working with a trusted partner who performs manufacturing, engineering, quality, and regulatory compliance due diligence on your behalf reduces your risk of getting distracted from the primary focus of the molecule and trials. Our consultants can be your person in-plant, qualify your suppliers, oversee contract manufacturing operations, and act as your project management office with our experienced project managers, engineers, and scientists. When you need to meet a higher standard and deliver for your stakeholders and patients, select CAI as your trusted advisor to take you from molecule discovery to Full Scale Operations.
Click the links below to read various case studies that highlight our experience in helping put life-saving products into patients' hands, or visit our Services page to learn about all of our capabilities.