Need to scale up or scale out? Collaborations are key to accelerating biomanufacturing

Collaborations are important in biopharma manufacturing because biologic medicines, particularly new modalities, such as nucleic acid vaccines and cell and gene therapies, are complex medicines with equally complex manufacturing processes. Few, if any, companies possess all the capabilities, technologies, or infrastructure required to develop and produce these medicines independently. During the pandemic we saw how collaborations between governments, industry, and academic institutions accelerated the development and manufacture of the COVID-19 vaccines. Additionally, collaborations can alleviate some of the challenges by helping to reduce costs, provide access to expertise, speed up production, and reduce the risks associated with scaling up or out.

Emerging technologies are strengthening collaborations

Emerging and maturing technologies, such as automation, Internet of Things (IoT), artificial intelligence (AI), and digital twins, serve as the critical “glue” to strengthen collaborations and accelerate the development and scaling of therapies in a more efficient and cost-effective way. Automation minimizes manual tasks and human error, establishing a reliable, repeatable foundation across functional teams. IoT enables seamless data collection and exchange across systems, while AI analyzes this data to support faster, more informed decision-making and anticipation of issues before they arise. Digital twins create a shared virtual environment where teams can simulate and refine processes without disrupting actual operations, enabling confident scale-up. Real-time monitoring and analytics ensure alignment across stakeholders, preserving quality and avoiding costly delays. When combined with flexible manufacturing technologies, these tools empower teams to rapidly respond to new products and shifting market demands.

Together, these technologies don’t just optimize operations—they empower teams to work better together, breaking down silos, accelerating progress, and ultimately helping to ensure the delivery of advanced therapeutics.

Collaborations can help companies navigate complex global markets

Collaborations help companies navigate the complexities of global markets by providing critical access to local expertise. For example, they can assist in facilitating a deeper understanding of diverse regulatory frameworks, allowing companies to meet compliance requirements more efficiently. Smaller biotech firms can benefit from the seasoned regulatory teams of larger biopharmaceutical collaborators, streamlining the often-intricate approval processes.

Joint efforts also lead to greater efficiencies in the documentation and reporting required by regulatory agencies, sharing the responsibility of compiling detailed data on safety, quality, and manufacturing practices. Such collaborations can strengthen quality control systems by combining resources to meet rigorous international standards. Perhaps most importantly, harmonized global efforts enable companies to pursue multi-country submissions, accelerating approvals and ultimately bringing vital therapies to patients more quickly.

What to consider in a collaborator?

Selecting the right manufacturing collaborator is one of the most critical decisions any biotech organization can make. It demands a thoughtful evaluation across multiple dimensions to ensure a strong, strategic fit. An ideal collaborator brings more than just experience, reliability, and regulatory compliance—they align with your company’s long-term vision.

Start by clearly defining what you need: identify your product’s stage, goals, and technical requirements, whether that’s clinical trial batches, regulatory support, or scale-up capabilities. Next, seek strategic alignment, your collaborator should understand and be genuinely excited about your mission, with shared priorities around speed, innovation, cost, and quality. Their track record matters too: assess whether they’ve successfully handled similar products, do they have cGMP certification, and how do they respond to and overcome challenges.

Technical expertise is non-negotiable. Can the collaborator handle the complexity of traditional biologics or advanced therapy products? Do they have the infrastructure to support seamless scaling from process development to clinical production to commercial production?

Regulatory strength is equally important. A qualified collaborator should be cGMP-certified and well-versed in navigating global regulatory requirements. A solid track record in meeting deadlines and solving unforeseen challenges speaks volumes about their resiliency and dependability. Adaptability is key in today’s dynamic biotech landscape. The ability to scale operations and adjust to shifting market demands is a significant advantage. At the same time, cost must reflect genuine value—not just in price, but in efficiency, reliability, and speed to market.

Together, these factors form the cornerstone of a successful, sustainable manufacturing relationship in the biotech space. When both parties are invested in mutual success, the collaboration can evolve from early-stage development all the way to full-scale commercialization.

Strong communication is also critical to any successful collaboration, so look for a collaborator who provides consistent and transparent updates and a responsive point of contact. While cost matters, focus on overall value—reliability, quality, and flexibility often outweigh the lowest bid.

Most importantly, think long-term. A collaborator who can grow with you across development phases will save time, prevent costly missteps, and build lasting trust. Start with a small pilot project to test the relationship before scaling up—this gives both parties the chance to align and refine collaboration early on.

The future of biopharma collaborations is poised to be more global, technologically advanced, and deeply patient-centric. As the industry continues to evolve, collaborations will increasingly center around cutting-edge therapies like mAbs, antibody drug conjugates (ADCs), cell and gene therapies, and nucleic acid-based treatments—areas that demand specialized capabilities and shared innovation. Cross-industry collaborations will continue to blur traditional boundaries, bringing together biotech, tech, and data sectors to accelerate innovation. At the same time, regulatory harmonization, sustainability, workforce development, and public-private collaborations will shape a more agile and responsible industry.

For companies seeking the right manufacturing collaborator, staying aligned with these forward-looking trends will be key to long-term success in a rapidly transforming biopharma landscape.

Joe Makowiecki is the Director, Product Management & Engineering, Product Solutions at Cytiva. He has over two decades of bioprocessing experience, focusing on driving innovation, strategy, and execution across multiple business units and cross-functional teams.