Swedish biotech VERIGRAFT outlines how it solved regenerative medicine’s manufacturing paradox, creating the first tissue therapy platform designed for industrial-scale production while maintaining patient personalisation.

Founded in Gothenburg in 2014, VERIGRAFT has achieved what many considered impossible in regenerative medicine: developing a tissue therapy that is both patient-specific and industrially scalable. The company’s lead product, P-TEV (Personalised Tissue-Engineered Vein), represents the first curative therapy for chronic venous insufficiency (CVI), a debilitating condition affecting millions worldwide where failing deep venous valves currently have no treatment options beyond symptom management.

Breaking the Manufacturing Paradox in Tissue Engineering

VERIGRAFT ‘s most significant breakthrough lies in solving regenerative medicine’s fundamental manufacturing challenge. CEO Petter Bjorquist explains how traditional tissue therapies have been trapped between personalisation and scalability: “One of the main challenges in tissue therapies has always been moving from research-level laboratory processes to reproducible, industrial-scale production.”

The company’s solution centers on embedding quality-by-design principles from the outset rather than retrofitting manufacturing processes later. “By developing closed, standardised processes and aligning with regulatory requirements early, we are creating a manufacturing pathway that allows tissue therapies to be scaled, industrialised, and ultimately commercialised,” Bjorquist notes.

This approach differentiates VERIGRAFT from other tissue engineering companies that typically struggle to transition from laboratory-scale production to commercial manufacturing. By designing for scalability from day one, the company has created what Bjorquist describes as “a step-change in regenerative medicine.”

Hybrid Manufacturing Strategy Balances Control and Efficiency

VERIGRAFT employs a strategic hybrid manufacturing model that other biotechs in advanced therapies could adapt for their own scaling challenges. The company retains critical know-how and intellectual property in-house while partnering with academic institutions, research institutes, and contract development and manufacturing organizations (CDMOs) for GMP manufacturing.

“This allows us to scale efficiently while retaining control of our critical processes,” Bjorquist explains. This approach enables the company to leverage external expertise and infrastructure while protecting core competitive advantages—a balance many biotechs struggle to achieve.

The hybrid model becomes particularly valuable when considering the specialized nature of tissue engineering. Rather than building expensive GMP facilities from scratch, VERIGRAFT can access established manufacturing capabilities while maintaining oversight of proprietary processes that define product quality and consistency.

Manufacturing Excellence Through Automation and Quality-by-Design

VERIGRAFT ‘s manufacturing strategy addresses the reproducibility challenges that have historically limited tissue therapies through two key innovations: automated, closed-system processes and early integration of quality-by-design principles.

“Ensuring reproducibility and meeting stringent quality standards has been a challenge. We address this through automated, closed-system processes and by embedding quality-by-design principles early in development,” Bjorquist states.

This manufacturing philosophy represents a significant departure from traditional tissue engineering approaches, which often rely on manual processes that are difficult to standardize. By automating critical manufacturing steps and designing quality controls into the process architecture, VERIGRAFT has created a pathway that other advanced therapy companies could apply to their own manufacturing challenges.

The closed-system approach also addresses contamination risks and regulatory requirements that have historically complicated tissue therapy manufacturing. This systematic approach to manufacturing excellence provides a template for other biotechs seeking to industrialize complex biological products.

Navigating First-in-Field Clinical Development

Having successfully completed Phase I/IIa trials demonstrating safety and encouraging efficacy signals, VERIGRAFT offers valuable insights for other biotechs conducting first-in-field clinical studies. The company’s approach emphasizes early stakeholder engagement and relationship building with clinical partners.

“Like many biotech companies in the field of advanced therapies, we initially faced challenges in regulatory navigation and trial design. By engaging early with regulators and building strong hospital and CRO interactions, we have been able to design robust studies and progress effectively,” Bjorquist explains.

The company’s clinical strategy highlights the importance of human factors in novel therapy development. Beyond scientific and regulatory considerations, success requires earning trust from healthcare providers who will ultimately deliver these therapies to patients.

Strategic Positioning for Commercialization

With approximately €18 million raised in combined equity and grant funding, VERIGRAFT demonstrates how European biotechs can leverage regional funding sources and support networks. The company benefits from Sweden’s life science ecosystem, including partnerships with Sahlgrenska Science Park, Business Region Gothenburg, SwedenBIO, and Business Sweden.

Over the next 12-18 months, VERIGRAFT plans to advance toward late-stage clinical development while expanding its platform into additional vascular indications and strengthening strategic partnerships for commercialization. This multi-pronged approach provides a roadmap for other biotechs transitioning from clinical validation to commercial preparation.

The company’s focus on platform expansion demonstrates strategic thinking beyond single-product development, creating multiple value drivers that could appeal to potential partners or acquirers.

As Bjorquist emphasized: “The biggest lesson has been the value of perseverance and transparency; clinical development rarely follows a straight line. My advice to other founders is to engage early with stakeholders, build trust, and never underestimate the importance of a strong team. Conducting first-in-field clinical studies is as much about people as it is about science – earning the trust of doctors and study personnel has been fundamental to our progress.”