In the highly competitive and rapidly evolving biopharma industry, choosing the right contract development and manufacturing organization (CDMO) is a critical decision that can significantly impact the success of a pharmaceutical development journey. When exploring potential CDMO partners, two key factors to consider are whether the company has a customer-centric approach, and if the team itself is cohesive.
In this blog, we delve into the strategies that can ensure an informed decision is made when choosing a CDMO, emphasizing the importance of customer-centric service, and the value derived from a cohesive team structure. We will highlight how these factors can set a CDMO apart from the competition and how focusing on these factors can impact project execution, project success, and client satisfaction. By understanding these strategies, a partnership with a CDMO can deliver optimal results throughout the drug development lifecycle.
Selecting a CDMO based on the strategies they implement
A customer-centric approach in CDMO companies places the needs, preferences, and satisfaction of the customer at the forefront of all decision-making processes and activities. It involves understanding the unique requirements of each customer and aligning resources and operations to deliver services that meet or exceed expectations. There are some key elements of a customer-centric approach to pursue in CDMO companies.
1. Focus on transparent and continuous communication
A CDMO should take a goal-orientated approach to fulfil customers’ needs. This should be with prioritization of transparent communication, to ensure clients are consistently and frequently informed about project progress. Seek a CDMO that prioritizes transparent communication. They should provide clear, detailed, and regular updates on project progress, challenges, and solutions. Open communication builds trust between the client and CDMO, ensuring the client is involved and informed throughout the development process. It is also essential during decision-making, to prevent delays and ensure decisions are timely and appropriate. The cohesiveness, communication, and execution of projects are paramount to ensuring accelerated pharma success.
2. Responsive and adaptable approach to collaboration
A customer-centric approach requires CDMOs to be responsive and adaptable to changing client needs. A supportive development and manufacturing partner should be flexible, agile, and able to accommodate new requests, adjust timelines, and address emerging challenges promptly to ensure customer satisfaction. A CDMO, for example, may employ a “platform-approach” to development, perhaps using a standard media set or other process strategies. However, a responsive CDMO will react according should the protein indicate other approaches are needed and will not be constrained by the platform. It is important to provide customized solutions that address the specific requirements of each client and molecule being developed. Considering a CDMO that can leverage its expertise and capability to develop tailored strategies, processes, and manufacturing solutions that align with the client’s objectives is highly advantageous when trying to deliver a product to market.
3. Extensive experience with diverse clients
Expertise within a CDMO should span the spectrum, enabling them to cater to both the unique needs of start-ups, as well as established industry leaders. This means that they can offer their clients solutions for all aspects of development and manufacturing due to their adaptability and understanding of diverse requirements.
4. Comprehensive regulatory knowledge and efficiency
Consider a CDMO company’s regulatory expertise and track record in meeting regulatory requirements of many different regions. Experience with clinical trial application (CTA) and investigational new drug (IND) filings and adherence to regulatory standards can expedite the approval process and prevent delays or additional studies. Assessing the CDMO’s track record of successful audits, including client audits, EU QP audits, and regulatory reviews will confirm the CDMO’s ability to maintain quality standards and meet regulatory requirements. This is essential to guarantee product safety and efficacy before they reach patients during clinical trials.
Expertise from an established team
Expertise and continuity are essential, as developing CMC processes for mammalian cell culture-derived therapeutics requires attention to detail. Biopharma developers benefit from working alongside a CDMO with knowledgeable, seasoned teams that are well established, with members fully integrating themselves into the company over many years. Having a reduced turnover mitigates the effects of communication issues and ensures continuity. This sort of continuity ensures institutional knowledge and expertise are retained and offered to clients, leading to consistent project execution and improved project outcomes.
Working alongside experienced project managers who are well-versed in industry best practices and regulatory requirements can further help streamline processes and ensure timely project execution and drive products to trial and eventually, patients, at an accelerated timeline.
Choosing a cohesive CDMO with a customer-centric approach
Working with a CDMO that has a customer focused service approach, alongside a cohesive, low-turnover team, is essential for success in biopharmaceutical development. When choosing a CDMO, it is advantageous to seek out a company that is dedicated to customer satisfaction, maintains transparent communication, and has efficient practices. Within this, a seasoned team will bring continuity and expertise to each project.
Bora Biologics fosters teamwork and camaraderie within their team. The team has grown together, with many members of the team having worked together for over 6 years. This translates through to client interactions, where subject matter experts provide consultative support, assisting clients in navigating the complex CMC road. By partnering with a CDMO like Bora Biologics, clients can expect a collaborative, and consultative experienced, accelerated timelines, and high-quality outcomes in their drug development journeys.