Bioproduction booms: How innovation is redefining biologics, vaccines and therapeutics

The biopharmaceutical manufacturing sector is entering a pivotal growth phase, propelled by escalating demand for biologics, vaccines and advanced therapies like cell and gene treatments. This surge challenges companies to scale increasingly complex processes efficiently, ensure regulatory compliance, and adopt sustainable, cost-effective production methods.

Bioproduction, the large-scale manufacture of pharmaceutical materials using renewable resources and bio-based technologies, is rapidly evolving from a niche capability into a core competitive differentiator. Over the past decade, the sector has grown steadily, yet concerns over its environmental footprint are prompting firms to prioritise sustainability alongside scalability and quality.

A 2024 research study explored whether biotechnology can lead the way toward a sustainable pharmaceutical industry. Scientists confirmed that biotechnology is an effective way to advance environmental, social and economic sustainability. Furthermore, quantitative impact assessments can provide a comprehensive overview of the bioproduction landscape and help drive the transition to a sustainable pharmaceutical sector.

However, as a 2025 research study found, viability, commercialisation and consumer acceptance pose serious risks to bioproduction development. Concerns about biomanufacturing’s scalability and the hype around its potential are also barriers to its growth.

The rising demand for biologics, the need to accelerate novel therapies into clinics, and to ensure the consistent delivery of commercial products drives bioproduction growth.

Biological therapeutics, or biologics, involve purifying proteins from living culture systems or blood to create medicines. They comprise a wide range of medicines, including vaccines, immune modulators and monoclonal antibodies.Advanced therapy medicinal products (ATMP) use genes, tissues or cells to develop new medicines that can treat diseases and injuries.

“New modalities have shown they can treat diseases that previously had poor standards of care,” said Emmanuelle Cameau, Scientific Director of Viral Vectors at Cytiva. Following their favourable results, drug developers are moving towards addressing more common diseases with these medicines.

“A significant factor is the continued shift toward more complex molecules, such as bispecific and trispecific antibodies or advanced fusion proteins,” Kasper Møller, Chief Technical Officer and General Manager of AGC Biologics’ Copenhagen Site, shared. Their increasing complexity requires greater investment in advanced analytical and process development capabilities to meet rising scientific and regulatory expectations.

“Now that cell and gene therapies have moved from hype to clinical reality, expansion into solid tumors and autoimmune diseases is dramatically increasing the number of patients who could benefit - if manufacturing could keep up,” said Fabian Gerlinghaus, Co-Founder and CEO at Cellares.

As biomanufacturing develops and manufacturers increasingly move from clinical trials to commercial production, pharmaceutical producers need more complex, and potentially larger manufacturing capabilities, to ensure they can produce scalable and compliant bioproduction platforms.

“Bioproduction is undergoing a massive transformation across the complete value chain,” said Cameau. Meeting commercial demand requires industrialisation. Reducing the time, it takes to develop therapies is key. Advanced analytical techniques that reduce sample volumes are contributing to lower costs, as more product is available to patients.

Advanced technologies such as automation and digitalisation through artificial intelligence (AI) and digital twins (virtual replicas of real-world processes) are supporting the design and operation of manufacturing facilities and processes. These tools aim to enhance efficiency, reduce contamination risks and improve consistency.

Automation technology and closed systems are transforming operational processes in biomanufacturing. “For cell and gene therapies, automation is the only viable path to scaling commercially and globally, by reducing operator error, minimising contamination risk, and enabling tens of thousands of patients per year to be treated,” said Gerlinghaus.

Digitalisation and driving data-driven quality support the pace of development. In recent years, operators produced 500-page paper batch records by hand for each patient dose.

“That model was unsustainable,” Gerlinghaus said. Platforms with flexible, software-defined architecture are expected to extend beyond cell therapy to accelerate timelines, strengthen regulatory confidence and ensure full traceability. “The transition to electronic batch records, automated release testing, and integrated quality control data streams is now one of the most impactful shifts in the field,” Gerlinghaus added.

Today’s manufacturers are using AI across modalities to revolutionise how these molecules are designed, engineered, processed and manufactured. The use of mechanistic modelling, advanced predictive modelling techniques, and process analytical technology (PAT) is increasingly featured in operational settings.

Although these technologies may not be fully implemented, pharmaceutical companies are on a trajectory to integrate them throughout their manufacturing operations to enhance reliability, traceability and responsiveness. “While AI is not yet part of our Good Manufacturing Practice (GMP) operations, we see its future potential to drive significant efficiencies,” said Møller. “The shift to fully automated processes and analytics will further drive growth and innovation in bioproduction by reducing footprint, labour and cost,” Gerlinghaus noted.

Advances in the therapies themselves are taking shape in today’s biomanufacturing industry. Innovation in mRNA, viral vector production, NK cells, Tregs, and stem cells is pushing the boundaries of what is clinically possible. “Manufacturing innovation has to keep pace if these technologies are to reach patients at scale,” said Gerlinghaus.

In ATMP development, technologies such as CAR-T in vivo, Exosomes and iPSC. Specifically for viral vectors, stable cell lines are, for example, starting to show their promise. “Performance is starting to positively improve cost,” Cameau said.

New solutions in digital signal processing (DSP), particularly for viral vectors, also show potential. In cell therapy, new solutions that facilitate rapid manufacturing and on-time release are accelerating manufacturing and improving delivery time to patients.

Putting design at the forefront of facility builds is a priority for biomanufacturers, who need to produce repeatable commercial output to keep up with demands. Using reliable clinical supply to achieve these means the industry must overcome numerous challenges in manual logistics, ad-hoc inventory, fragile cold-chain steps, and inefficiencies within the workflow. In turn, this creates risks that threaten scalability.

“In viral vectors, scalability is not a challenge, as long as reagents and processes are well defined,” Cameau said. There have been some hurdles to approval due to Chemistry Manufacturing Controls (CMC) requirements not being sufficiently met. Therefore, managing and controlling risks by implementing a thorough and robust risk management strategy is essential.

Quality targets will continue to increase as technologies and modalities mature to treat more prevalent diseases. “Quality and safety will become even more scrutinized,” Cameau said. An increased focus on these parameters reflects advances in technologies and modalities, which are now being developed for other non-life-threatening conditions.

Addressing the changing requirements and expectations in the drug development process requires manufacturers to review and redesign their industry processes. “Technologies like continuous processing and process analytical technology could address some of the challenges with scale-up, quality and sustainability,” Møller added.

To stay on top of consumer demands, manufacturers that integrate sustainability initiatives and metrics into their value chains and share best practices across the industry will contribute to a collective push for sustainable manufacturing.

The growing complexity of modalities can place greater demands on a biopharma manufacturer’s capabilities to meet rising scientific and regulatory expectations. “A key challenge is adapting existing GMP-compliant operations with new technologies, which takes time and requires significant regulatory precision,” said Møller.

“Regulators have made a lot of progress, but of course, it’s difficult for them to advance at the same speed as science,” said Cameau. Cross-industry collaboration and a shared understanding of legal and scientific developments are vital, especially as more companies are developing therapies. “A more collaborative approach would ensure that the specificities of these new drugs are understood, and the authorities can make informed choices when developing them,” Cameau added.

In June 2025, the FDA removed Risk Evaluation and Mitigation Strategies (REMS) requirements for autologous CAR-Ts. Lifting this requirement is thought to expand the number of treatment centres qualified to administer them, and patients will no longer need to remain near hospitals for weeks after infusion. “Together, these scientific and regulatory advancements are unlocking a surge in demand for commercially accessible CAR-T therapies,” Gerlinghaus added.

Current challenges have revealed the hard limits of traditional, manual biomanufacturing and are accelerating the shift to industrialized, automated production.

“Patients are dying on waitlists because life-saving CAR-T therapies remain capped at only a few thousand doses per year,” said Gerlinghaus.

As advanced therapies move from rare to common and prevalent diseases, they are demanding industrial-scale solutions. Process intensification and getting more out of less through increasing quality and potency are expected to help reduce overall costs.

“Analytics are still the ‘black sheep’ as advanced analytical techniques are still in their early stages of being adopted and approved by regulatory authorities,” Cameau. This is changing and broader adoption of such techniques will likely contribute to their standardization and lower dosage costs.

“New facilities are being designed for flexibility rather than being tied to a single product, incorporating advanced automation and digitalization from the start,” said Møller. “High costs, high failure rates, and complex regulatory requirements are pushing biotechs and pharma away from building bespoke facilities and toward standardized, automated platforms,” Gerlinghaus added.

As bioproduction continues its rapid evolution, pharma manufacturers must proactively invest in modular, automated and digitalised manufacturing platforms to remain competitive. Early adopters will benefit from reduced costs, faster commercialisation and enhanced regulatory confidence.

How prepared is your organisation to meet the demands of next-generation biopharmaceutical manufacturing? Now is the time to assess your capabilities, adopt flexible manufacturing solutions and embrace the digital transformation shaping the future of bioproduction.