In the biotech industry today, mergers, acquisitions, and joint ventures are announced daily. Startup companies with viable molecules must decide early how they are going to 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 different for 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 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 prove to be catastrophic to a small company launching their initial product. Having a competent firm with expertise in manufacturing and supply chain management to partner with can ease these worries by auditing and providing the necessary oversight to verify your partners can perform at the level promised.
Building a small, modular facility offers the opportunity for owner flexibility to quickly modify the process during startup, 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 with cutting edge software such as BioVoke, major capital expenditure can be delayed until preliminary clinical trial results are positive.
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 just 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 with a focus on the implementing 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.
Documenting the science behind your molecule and process development throughout the R&D process is an integral part of a successful NDA. BioVoke tracks your product and process Critical Quality Attributes (CQAs) and Key Process Parameters (KPPs) and links those Process User Requirements, Design Controls, and an overall quality risk management approach. Having these items documented clarifies the design philosophy allowing the 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 your most vulnerable early development. Working with your partner so they can perform 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 team of Owner’s Project Managers.
When you need to meet a higher standard and deliver for your stakeholders and patients, select Commissioning Agents as your trusted advisor to take you from molecule to Full Scale Operations.