By Kevin Sharp
At every step of biopharmaceutical development, disruptions can occur, costs can mount, and timelines can lengthen, slowing the delivery of critical medicines to patients. To manage these risks, developers may collaborate with external partners that have experience integrating varied bioprocessing operations. For example, developers may partner with contract development and manufacturing organizations (CDMOs). However, successful collaborations with CDMOs can be challenging to engineer.
How can developers get the most out of their partners from the very beginning of the relationship? Here are some thoughts on choosing the right CDMO partner to build more strategic supplier relationships and make better biologics from the start.
One essential goal is to find the smartest partner. Such a partner is a good fit for the developer, has expertise relevant to the developer’s molecule, and is able to provide transparency and visibility into operations, markets, and supply chains. And, as this article explains, such a partner is able to execute certain key tasks. These tasks are highlighted in the sections that follow.
Accelerating the critical path effectively
Sponsors are looking to contract development partners to develop their novel therapeutic antibodies as quickly as possible for a faster investigational new drug application (IND) approval. Assuring timing of market entry is becoming critical to development and market dominance.
Single gene expression platform–based strategies are proving effective at reducing timelines for cell line development. Dedicated single-platform standardization supports efficient process development (including upstream process, downstream process, and analytical method development) and formulation for Phase I trials.
To take a molecule seamlessly across the continuum of drug substance (DS) and drug product (DP) development, manufacturing, and IND filing, partnering with a CDMO that offers end-to-end services is often the best route to expedite development and commercial timelines. Partnering is an option for all biopharma firms, but for the small startup and virtual biopharma firms that are developing today’s breakthroughs, it’s the only route available.
With gene expression technology, the transition from the laboratory to the production facility must be optimized to shorten development timelines and speed entry into clinical stages. Doing so also facilitates technology transfer later in the program.
Optimizing processes, technology transfers, and yields
Optimizing upstream and downstream bioprocesses to reduce processing times, resource volumes, and processing steps while attempting to increase yields can be challenging in early development. One of the biggest challenges is dealing with differences in size and scale. For example, the batch volumes during clinical development are smaller than the volumes of the commercial bioreactors commonly used by leading biopharma CDMOs.
Undertaking a facility fit assessment early in the CDMO recruitment process is an essential element of a successful long-term commercial partnering strategy. Developers and their prospective commercial partners need to understand as early as possible any equipment gaps or process changes that may be required, as well as ways to expedite technology transfer. Here, factors such as R&D, business continuity, investment in continuous improvement to operations, financial stability, and growth should all be considered.
Companies offering a digitally advanced current good practice (cGxP) operating and manufacturing ecosystem are likely to offer better systems and data sharing tools. Data sharing protocols, as well as standard operating procedures, support this critical element of collaboration between drug sponsor and CDMO and ultimately generate better program outcomes.
Managing systems for direct visibility into product campaigns
There are many complexities in biopharma development, manufacturing, and supply chain management. Digital technologies can support more efficient processes, enhancing collaboration and quality control. Ultimately, digital technologies can ensure more consistent quality of manufacturing.
When looking to improve a molecule’s prospects, drug developers should consider partnering with CDMOs that leverage the interconnectivity of the cloud and the actionable data generated by their informatics and analytical tools.
Utilizing collaborative interoperable platforms, CDMOs have access to the digital solutions they need to leverage and connect external partners and collective data sources effectively. Those organizations will have more efficient, compliant operations that de-risk long-term drug development strategies.
Connecting programs to a digitally transparent supply chain
During the pandemic, pharma’s highly branched supply chains were severely tested. According to a market survey conducted by IDC, 74% of responding suppliers were achieving 98% or better on-time and in-full (OTIF) delivery rates before COVID-19. After the first pandemic year, OTIF rates for responding suppliers sank by 28%.
How partners manage their raw material supply chains is another strategic element that should be scrutinized. Although the transition to digital management has been slow, the spotlight that the pandemic put on the drug manufacturing supply chain is accelerating the trend.
Biopharma supply chains are invariably global, and collaborative digital information and cloud-based data sharing technologies are emerging that can help managers track inventory rates and ensure compliance for program assets such as active pharmaceutical ingredients and excipients.
Tracing finished goods throughout the distribution side of a pharma supply chain is another way digital technologies can support CDMO operations. Many of today’s biopharmaceuticals and personalized medicines require careful monitoring to verify cold chain of custody.
Opening and sustaining high-fidelity communications
Easily accessible and timely interpersonal communications have always been a hallmark of a strong, strategic CDMO. With the advent of social distancing, the ability to communicate virtually became a virtue relative to managing existing program communications and standard operating procedures, as well as on-boarding prospective programs and demonstrating processing capabilities.
Live virtual tours and virtual inspections have emerged as effective tools that can help clients and regulatory auditors remotely assess facilities as if they were physically there. High-fidelity virtual communications are now a must for global pharmaceutical commerce, and strong commercial partners will be the ones to offer such communications through easy-to-access, shared digital environments.
Strategic intelligence can also be demonstrated by how an organization finds ways to accelerate programs and critical timelines.
Preparing for what’s to come
Leveraging the agility of smarter, digitally prepared partners should be a key goal. Identifying the most technically and operationally strong CDMO partner relative to the candidate molecule is essential to launching any drug program. However, given today’s diverse development trends and the growing length of drug product life cycles, drug programs can last decades.
Finding a smart, flexible CDMO to best serve the needs of the molecule is the first critical step toward ensuring a successful drug program outcome. But before signing a CDMO, consider its strategic strengths carefully and evaluate its digital capabilities thoroughly.
CDMO partners offering advanced data-driven operating environments are more likely to accelerate efficient development and deliver end-to-end drug program success.
Kevin Sharp is head of alliance management at Samsung Biologics.