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The cell and gene therapy (CGT) market is experiencing tremendous growth. Some leading-edge therapeutics are curative, creating a massive demand from patient populations and substantive interest from investment groups fueling the desire for rapid development.
At the same time, development and manufacturing of CGTs are complex. For instance, personalized autologous therapies, the current prevailing option due to technical limitations, are difficult to scale out and distribute geographically. There is a shortage of highly qualified technical personnel, manufacturing platforms are still in development and current approaches often involve open steps with numerous manual interventions, resulting in inefficiency and reduced process control at a higher cost. The science has yet to reach a level of standardization and efficiency to repeatedly produce robust data while scaling to meet demand.
This conundrum creates a knock-on effect due to compounding costs and risks associated with meeting internal milestones to produce strong clinical data for regulators and investors alike. Although some process development shortcomings may be resolvable, inevitably they will extend timelines with significant impact to funding and resources. This creates an inflection point for many companies. Is their process and data convincing enough to secure additional funding, do they continue to do more work with fewer resources, or does this lead to the demise of the product and company?
Rapid growth is desired but the process of developing a drug from the initial discovery phase through commercialization is laden with costs, including numerous facilities and an expansive workforce, each dedicated to a certain stage, like R&D or manufacturing.
The SmartLabs’ Solution
SmartLabs’ solution is a next-generation modality-agnostic laboratory platform—a facility that can host and co-locate drug discovery, development and GMP manufacturing all under one roof. Co-location maximizes resource allocation and significantly reduces capital investment needs for non-scientific services, like facility design, laboratory operations management, or environmental health and safety programs.
These services are built into the SmartLabs model eliminating the need for companies to resource non-scientific disciplines, thereby allowing them to focus on the technical challenges of developing a robust and scalable process. Clients at all stages can benefit from SmartLabs’ solutions—from companies just starting out to those entering the clinical trial and commercialization stages.
“We integrate clients into our ecosystem and offer expertise in establishing programs along with introductions to our strategic partners,” explained Joel Itkin, Director of cGMP Quality at SmartLabs. “We understand that therapeutic developers want a turnkey manufacturing facility that caters to their specific needs and allows them to set up and begin executing their process with minimal delays. Yet, they also need flexibility to mitigate uncertainty.”
Customizable, Flexible, and Phase Compliant
The modular SmartLabs facilities are customizable, flexible and phase-compliant, and can be changed as needs dictate. The company’s unique model makes the process simple and quick, reducing clients’ overhead and preserving their funds. This model also facilitates all stages of the development life cycle under one roof, from early-stage offerings such as a vivarium for preclinical in vivo work and innovation and scaling labs with shared equipment to late-stage offerings like GMP-compliant clean rooms for clinical trial and commercial manufacturing.
“Our unique value proposition significantly reduces capital expenses for starting up a new manufacturing process and developing it for product commercialization,” Itkin emphasized. “Our facilities and management expertise mirrors a large portion of what a CDMO offers. Importantly, our clients remain in control. They own their manufacturing process and IP.”
SmartLabs’ processes are governed by structured policies and standard operating procedures to ensure compliant, harmonized, and effective support throughout all facilities. Additionally, SmartLabs maintains in-house experts, enabling customers to have rapid access to subject-matter expertise and support in areas such as aseptic processing, inventory management, facility design, laboratory management, and more.
As a company founded to help future-proof the life sciences industry and accelerate the pace of scientific breakthroughs, SmartLabs seamlessly integrates new processes as technology evolves. “We are set up to embrace change. We grow in parallel with our clients,” said Itkin. “We want to be on the cutting edge with them and enable success in an industry that holds more potential than ever before but is also rife with challenges and constantly shifting needs.”
Co-location simplifies the transitions through the drug development journey so that scientists and resources are optimized, positioning companies for success in bringing transformative therapies to market. SmartLabs’ industry-leading solutions are designed to get the job done now, while looking towards the future.
To explore our solutions visit www.SmartLabs.com.