Mike Schaefers is chief commercial officer at Simtra BioPharma Solutions.

Mike Schaefers

 are critical components of therapeutic innovation that require significant investments of time, money, and intellectual capital. Speeding the delivery of new therapeutics to market and, ultimately, to patients demands novel approaches that reduce drug and process development complexity, minimize failures, and ensure that every step in the long road from bench to bedside is executed with precision. Achieving precision along a continuum that requires expertise across multiple disciplines, including biology, chemistry, formulation development, manufacturing process development, and clinical and regulatory science, is challenging, especially for small- and mid-size biopharmaceutical companies that may have personnel and infrastructure limitations.

Rather than building capacity internally, these companies can partner with contract development manufacturing organizations (CDMOs) and other external vendors to access critical knowledge, experience, and infrastructure.

Selecting a CDMO is a complex decision. While “one-stop shops” minimize the number of relationships that need to be managed, they may not have leading expertise in every step of the continuum. This lack of comprehensive expertise may be especially true with increasingly complex drug molecules, such as antibody-drug conjugates (ADCs). Alternatively, working with multiple vendors, each with expertise in a particular aspect of drug development, can be difficult to manage and creates opportunities for missteps if the hand-off from one vendor to the next is not done seamlessly.

 that have established their own partnerships with other leaders can be the balance point between these two less than optimal options. Such partnerships allow integration of processes that ensure seamless progression from one end of the continuum to the other. Here, the author discuss the role of CDMO expert networks in streamlining high-quality drug development and reducing drug development timelines and costs.

What is the role of CDMOs across key steps in the drug development continuum? 

Opting to work with multiple specialist CDMOs rather than a single, one-stop shop can provide companies with essential and relevant expertise at each step in the development process. For example, a company seeking CDMO support for development of a novel ADC could work with one CDMO that has expertise in bioconjugation (linking the antibody to the therapeutic payload) and another CDMO that has deep experience in filling and lyophilizing biologic therapies. These are distinct skill sets, and optimizing both is essential for attaining the CQAs (safety, potency, stability) needed for clinical and commercial success.

CDMOs have extensive experience that can be leveraged to streamline development, reduce the time and cost of development, and avoid errors/missteps that can lead to costly delays in the future. Given the frequency and scale at which they perform key steps in the development process, CDMOs can provide unique insights and expertise in areas such as drug formulation for injectable medicines, lyophilization cycle development and optimization, analytical methods and process development, and packaging selection to achieve critical quality attributes (CQAs).

Such capabilities may be especially valuable for emerging/small biopharma companies that lack the time and/or financial resources to build these capabilities internally. These capabilities can also provide value to larger biopharma companies that may need external support for a small number of molecules, especially more complex molecules, such as ADCs, or other modalities with which they have less experience or interest in building internal capabilities.

For example, a larger biopharma company with established expertise in small molecule oncology drug development that is expanding into biologic oncology therapy may be able to move more quickly and cost-effectively by working with a CDMO, which would mitigate the need to hire additional personnel or invest in physical infrastructure. Regardless of a company’s size or development stage, an experienced CDMO can be an important resource when developing ADCs and other high-potency molecules requiring specialized handling protocols and infrastructure that bigger companies may not want to invest in internally.

Opportunities and challenges in building a CDMO network

While this approach can tailor CDMO resources to the specific needs of a particular therapeutic molecule, it also can present its own challenges. These include the need to manage multiple vendors and ensure a smooth and timely hand-off from one vendor to the next. This approach becomes increasingly complex with the engagement of additional specialist CDMOs, and the benefits gained by accessing specific competencies may be negated by the time and energy needed to manage the network.

Working with multiple CDMOs can create procurement/management challenges, especially for smaller biopharma companies with limited resources to support these functions. The hand-off from one CDMO to another may be complicated by logistical challenges (shipping, receiving, documentation, etc.). Lack of coordination/integration between CDMOs also may lead to duplication of work due to poor communication or as the result of difference in processes/methods for a particular work stream between the organizations.

Why leverage existing relationships among CDMOs?

Selecting CDMOs that already have effective relationships with each other can help to minimize some of these challenges and reduce burdens on the drug development partner. When done well, CDMO alliances have the potential to create a seamless user experience. Whether building a bespoke CDMO network or accessing resources through an existing alliance between CDMOs, it is critical that all players share the belief that reducing the cost, time, and complexity of developing and manufacturing biopharma products is essential for delivering medicines to patients.

The CDMO industry has the expertise, resources, and capacity to play a critical role in transforming decades-old approaches that fail to maximize value for patients, drug innovators, and health systems. Creating a new paradigm that brings optimized expertise to each step of the development and manufacturing continuum requires inter-vendor partnerships and networks that provide a seamless user experience and time and cost savings compared with traditional approaches.

With more innovation happening in emerging and small biopharma companies, there is a growing need for CDMOs that have expertise in supporting novel, complex molecule development (ADCs, bi-specific or tri-specific antibodies, etc.). As biopharma companies consider how best to access the knowledge and infrastructure needed for timely and cost-effective development of potentially transformative therapies, they should consider not only the capabilities of a potential CDMO partner but also the relationships that the CDMO has with other vendors.

CDMOs should evaluate the areas in which they provide differentiated capabilities and consider partnering with other CDMOs that provide complementary (but largely non-overlapping) expertise. Establishing these types of partnerships requires identifying areas of potential overlap and defining at the outset which organization is responsible for each part of the service offering chain. Protecting key trade secrets is also critical for eliminating the risk that today’s partner doesn’t become tomorrow's competitor and ensuring that these collaborations provide long-term value to each CDMO

The growing need for new types of expertise and capabilities that comes with the rise of novel treatment modalities (i.e., additional antibody-based therapies, gene and cell therapies, and DNA and RNA editing therapies) is a powerful driver for CDMO specialization. DNA and RNA editing approaches require expertise in nucleotide chemistries; ADCs require lyophilization expertise and the infrastructure for handling high-potency payloads; and there is a growing need for capabilities in developing and formulating therapies with novel viral and non-viral delivery systems. Specialist CDMOs that work together to provide end-to-end expert support for these innovative modalities can create value for themselves, their drug development partners, and, ultimately, the patients that should always be at the center of the drug development process.

Case study: Simtra and MilliporeSigma ADC partnership

A recent partnership between Simtra BioPharma Solutions and MilliporeSigma provides an example of how integrating specialized capabilities in ADC drug substance manufacturing and bioconjugation and ADC fill/finish provides the developer with a seamless user experience that can streamline drug development. Established in June 2025, the partnership combines MilliporeSigma’s bioconjugation expertise and Simtra’s fill/finish capabilities, especially with respect to lyophilization formulation development (1).

ADC manufacturing is complex because it requires combining a monoclonal antibody (mAb), a cytotoxic payload, and a linker, each of which has its own production challenges. The targeted result is a single therapeutic molecule that is safe, potent, effective, and stable. Specialized infrastructure is needed when working with cytotoxic molecules, before, during, and after bioconjugation to the mAb. Additionally, approximately 90% of commercially available ADCs are formulated as lyophilized powders for reconstitution to optimize ADC stability and extend product half-life (2). In the absence of a one-size-fits-all process, optimizing ADC development requires expertise in antibody biology, bioconjugation chemistry, payload handling, and lyophilization formulation. The processes put in place for the development of each ADC must also be scalable to meet late-stage clinical and commercial needs.

The purpose of the MilliporeSigma–Simtra partnership is to provide a turnkey offering for biopharma companies seeking seamless access to expertise in ADC and bioconjugation, linker/payload manufacturing, drug product formulation development, and fill/finish capabilities. Designated project managers at each company work closely together with each other to ensure smooth transfers and expedited timelines. This work is done through the development and use of detailed plans for each joint project outlining agreed-upon processes, timelines, documentation, and transfer protocols. With this approach, Simtra can immediately begin work on drug substance materials received from MilliporeSigma. Ongoing communication between the teams also provides an effective mechanism for addressing questions or challenges collaboratively and in a timely manner.

The business rationale for this partnership was grounded in the recognition that working together could allow each company to capture a larger share of the expanding ADC pipeline. With more than 200 ADCs currently in clinical development (3), and about another 250 in discovery/pre-clinical development stages (4), the need for ADC bioconjugation and formulation process development expertise is rapidly growing. MilliporeSigma has extensive expertise in bioconjugation while Simtra has differentiated capabilities with respect to ADC lyophilization, formulation development, analytical process development, and package selection. Working collaboratively opens new doors for each company while providing drug development partners with a seamless user experience that gives them access to industry-leading expertise for key steps in the ADC development continuum. This partnership is just one example of how CDMOs can gain more through collaboration when each side provides complementary services rather than competing against each other. For development partners, the ability to access the expertise they need in a seamless fashion allows the partnership to provide greater value than the sum of its parts.

Decades-old drug development and manufacturing process development approaches are not optimized for modern-day biopharma products, and there is an evolving and expanding market demand for specialized expertise that can support the development of novel therapeutic modalities. CDMOs have a critical role to play in establishing new paradigms that reduce development time and costs and ensure timely and sustainable delivery of cutting-edge therapeutics to patients in need.To capitalize on this opportunity, CDMOs must identify organizations with complementary services and build new models that expand access to optimized expertise at every step in the process.Working together, CDMOs can create the continuum of expertise that customers need and patients deserve.

Simtra BioPharma Solutions and MilliporeSigma Announce Strategic Alliance for Antibody Drug Conjugates Drug Substance andDrug Product Manufacturing Services

Wen, L.; Zhang, Y.; Sun, C.; et al. Fundamental Properties and Principal Areas of Focus in Antibody-Drug Conjugates Formulation Development. 

Colombo, R.; Tarantino, P.; Rich, J. R.; et al. The Journey of Antibody-Drug Conjugates: Lessons Learned from 40 Years of Development. 

Antibody Drug Conjugate Market Industry Trends and Global Forecasts to 2035, by Target Disease Indication, Therapeutic Area, Linker, Payload, Target Antigens and Key Geographical Regions

Articles

Drug and process development demands cross-disciplinary precision that smaller and mid-size biopharma often cannot resource internally. CDMOs can compress timelines and reduce downstream failures via formulation, lyophilization, analytical, process, and packaging expertise, particularly for complex modalities such as ADCs and other high-potency products. However, single “one-stop” providers may lack best-in-class depth, while multi-vendor models increase hand-off and governance risk. CDMO alliances with complementary, non-overlapping strengths can create an end-to-end, seamless operating model with clearer accountability and improved execution.

Integrated CDMO networks streamline complex drug development across advanced modalities like ADCs. 