8 key partner quality attributes your CDMO must have
By Pauline Ginsberg, PMP, Director of Project Management
Pauline has 20+ years of pharmaceutical industry experience holding various leadership roles. She has partnered with global clients, ranging from biotech innovators to pharmaceutical sector leaders, to advance more than 40 compounds through all development stages, from pre-clinical through launch and commercialization.
Drug complexity, prevailing drug development economics, and speed to market are leading to an increasing reliance on contract manufacturers to span gaps in experience and capacity. As a result, demand for contract development and manufacturing (“CDMO”) services is rising rapidly. The biopharmaceutical fill finish manufacturing market was approximately $7.5 billion in 2020 and is projected to reach $12.1 billion by 2025 at compounded annual growth rate of 10% during the forecast period.1
As a result of the rising demand for biotech innovations and pharmaceuticals, especially biologics and vaccines, it becomes easier to understand why many industry stakeholders engage CDMOs to help mitigate the complexity and costs associated with drug substance development and drug product manufacturing. Identifying the best CDMO with which to partner has become an integral component of many biopharma businesses. Their successful commercial drug development strategy depends on it. Here are the eight key Partner Quality Attributes (PQAs) your CDMO partner should have:
- 1. Open, deliberate, institutionalized transparency
To be successful, trust and transparency must be engineered into a CDMO partnership from the start. What sets the great apart from the good is how quickly that transparency can be established and felt throughout the relationship. Partners with very deliberate approaches to access and candid engagement are more likely to achieve that essential trust required to drive program success from formulation, fill, and finish services (and everything in between).
- 2. An agnostic perspective regarding partners and projects – come one, come all
Whether a biopharma program is commercial or clinical, large or small, great CDMO partners should be nimble and flexible. It’s a critical attribute of partner quality: efficient CDMOs must have configurable, scalable operations that can accommodate a program’s specific capacity and production. Facilities and production lines, for example, should be purposefully engineered to be program-agnostic to accommodate change and support products at every stage of a drug product’s life cycle. CDMOs that treat every client in the same manner, large or small, is another critical partner quality attribute to watch for – because harnessing a molecule’s potential therapeutic impact is the most important aspect of an overall project or relationship.
- 3. Responsible understanding and stewardship of time, money, and resources
Operational inefficiencies across a given enterprise can obviously hurt program financials. However, cost effectiveness will always be subordinate to operator safety and sterile containment. In this case, the key to cost effectiveness and program speed is how well the organization achieves operational excellence. A great CDMO partner can leverage information technology and automation in from the newest, top-of-the-line platforms to provide the visibility needed for informed decision making, while helping to sustain cost-effective sterile parenteral drug manufacturing operations.
- 4. Ample and growing capacity for sterile injectables
The life sciences community’s response to the pandemic was nothing short of phenomenal; however, COVID-19 vaccine development and subsequent manufacturing consumed a substantial amount of the global capacity for sterile injectable fill and finish services for a multitude of other crucial therapies and breakthrough product launches. The pandemic exacerbated the lack of availability of capacity, an issue that had been challenging the rest of the biologic development community long before COVID-19 arrived. A great CDMO partner will be able to allocate specific, scheduled capacity for your complex project.
- 5. State-of-the-industry capabilities
Over the last several decades, the industry’s process designers, equipment suppliers, and systems engineers have made great strides in exceeding the quality and safety that patients, doctors, regulators, and markets demand. Facilities coming online now have the benefit of clear industry hindsight and a purpose built for the task. The new standards for an effective CDMO partner include the latest advances in aseptic controls and containment, optimal-speed filling, finishing, and packaging equipment, as well as the control, data management, and analytics. Great CDMOs let you be there every step of the way with your product. Whether it’s in the cleanroom or in the QC lab, great CDMOs welcome you onto the field to experience the first-hand play-by-play alongside your product.
- 6. A need for speed: program accelerating capabilities
Experienced drug strategists engage CDMOs precisely because of their expert, experienced manufacturing teams. CDMOs are proven drug development timeline accelerators. For parenteral developers, a great quality attribute of your CDMO partner is to have deep experience with aseptic processes and operations to reliably deliver complex and challenging sterile injectable drug products. A great fill-finish partner will bring the latest technology to the table to expedite compliant, quality batch releases and deliver drug product to the finish line when compared to the status quo.
- 7. Robust teams steeped in pharma quality culture
Strategic partnerships and successful drug programs are built on the strength and agility of a CDMO partner’s enterprise. The character and culture of a CDMO’s quality, operations, business, and manufacturing teams should be clearly articulated – it’s a critical element of discovery. But, in addition to all the technical know-how and capacity, the success of the entire program often rests upon a fundamental quasi-emotional tie: “I really think we can work well with these people because we all put quality first.” It is a critical quality attribute and central to productive transparent relationships with great CDMOs in the biopharma industry.
- 8. A true partnership approach to business
Whether it’s providing end-to-end commercial development and manufacturing services to help the licensors and licensees of an immuno-oncology breakthrough therapy reach patients and enter markets faster or quickly delivering millions of critical finished vaccine doses worldwide during times of need, the choice of who to partner with has become a primary “determiner” of program success. Choosing the great CDMOs who have the experience, flexibility, and customer-centric focus stand out from the field. They are well-equipped from the start, helping form alliances to bring new products to market. Biopharma industry leaders must leverage the greats to meet an ever-growing demand for producing and delivering medicines with momentum.
[1] Bloomberg.com. “Fill Finish Manufacturing Market Worth $12.1 Billion by 2025 – Exclusive Report by MarketsandMarkets,” May 18, 2020. https://www.bloomberg.com/press-releases/2020-05-18/fill-finish-manufacturing-market-worth-12-1-billion-by-2025-exclusive-report-by-marketsandmarkets.