Can Manufacturing Keep Up with Biopharma Innovation?

Authored by Adam Pfeiffer, Vice President

Biopharma innovation is accelerating at an unprecedented pace, with new therapies, platforms, and technologies reshaping the industry. But as groundbreaking treatments move forward, a critical question remains: Can manufacturing infrastructure scale fast enough to meet demand?

Below, we highlight three recent developments that are shaping the future of bioprocessing, scalability, and supply chains. From a major CAR-T investment addressing production bottlenecks to a Phase 3 program tackling an unmet medical need and AI-driven approaches to next-gen biologics, these milestones underscore the rapid evolution of biotech manufacturing.

J&J and Legend Biotech's $150M Investment to Double Carvykti Production

Carvykti, a CAR-T therapy for multiple myeloma, is on the verge of blockbuster status. In 2024, it generated $963 million in sales, and with expanded second-line FDA approval dramatically expanding its eligible patient population, demand is surging. However, CAR-T therapies require patient-specific, highly complex manufacturing, with lead times often exceeding a month -- posing a major scalability challenge.

To address this, Johnson & Johnson and Legend Biotech are investing $150 million to expand manufacturing and increase Carvykti's production capacity to 10,000 treatment slots annually by the end of 2025.

How will this be achieved?

• J&J and Legend are expanding their Tech Lane facility in Belgium
• Production is ramping up at their Raritan, NJ site
• They are leveraging contract manufacturing from Novartis in New Jersey

This investment highlights the growing reliance on CDMOs to scale personalized medicine and meet patient demand. As the industry works to remove manufacturing bottlenecks, the ability to produce CAR-T therapies efficiently will be critical for broader patient access.

Vir Biotechnology's Phase 3 ECLIPSE Program for Chronic Hepatitis Delta

Chronic hepatitis delta remains one of the most severe liver diseases with no FDA-approved therapies in the US. That could soon change with Vir Biotechnology's Phase 3 ECLIPSE program, which recently enrolled its first patient.

The treatment combines:

• Tobevibart -- a monoclonal antibody
• Elebsiran -- an RNA based therapy

This combination has already demonstrated strong viral suppression in Phase 2 trials and has received multiple Breakthrough and Fast Track designations from the FDA. However, manufacturing this combination poses a unique challenge, as it requires integrating two distinct biologic production processes: monoclonal antibody development and RNA-based therapeutics.

If successful, Vir will need regionalized production hubs, particularly in Europe, to meet demand, where a separate Phase 2b trial is supporting reimbursement discussions. The ECLIPSE program's success could influence manufacturing strategies for future combination biologics, reinforcing the need for flexible, scalable production platforms.

ImmunoPrecise's $10M AI-Powered ADC and Bispecific Antibody Partnership

AI is making its mark on biologics manufacturing, and ImmunoPrecise Antibodies is at the forefront of this shift. The company recently secured a $10 million collaboration with a leading biotech company to develop next-generation antibody-drug conjugates (ADCs) and bispecific antibodies for cancer treatment -- using an AI-driven approach to discovery and optimization.

ADCs require highly specialized bioprocessing, particularly in ensuring:

• Consistent conjugation
• Payload linker stability
• Scalability of complex workflows

ImmunoPrecise is leveraging AI-driven multi-omics modeling to accelerate antibody discovery and candidate selection, which could help streamline CMC processes. If successful, this approach could significantly shorten development timelines, reduce costs, and enhance production efficiency. As the industry moves toward computationally optimized biologics manufacturing, AI's role in process development will continue to expand.

Final Thoughts

These three developments underscore a crucial trend: as innovation accelerates, the industry must leverage every tool available to keep manufacturing capacity on pace. Investments in CAR-T production, new approaches to combination biologics, and AI-driven process optimization are all shaping the next era of biotech manufacturing.

About Project Farma

Project Farma is a patient-focused global leader in advancing technical operations from ideation through commercialization with a proven track record of planning, building, and maintaining manufacturing facilities, capital expansions, and technical operations for complex biologics and novel modalities. Project Farma has executed 100+ facility builds, retrofits and expansions, managed 400+ large-scale capital projects, industrialized 10+ commercial cell, gene, and novel therapies, and managed $6B+ in technical operations capital investments.

Partnering with leading pharmaceutical companies, advanced therapy organizations, universities, hospitals, and government agencies, our team of experts drives innovation in technical operations and manufacturing to support the advancement of groundbreaking therapies for patients in need. For more information, visit www.projectfarma.com