A biotech company developing an autologous CAR-T cell therapy was preparing to enter Phase 2 clinical trials and needed to rapidly scale up manufacturing capacity. Their internal infrastructure was insufficient to meet growing demand, and they needed a fully operational GMP solution within 12 months to maintain momentum in clinical development.
The client faced the dual challenge of tight timelines and the need for a scalable, regulatory-compliant solution to support increased production. Their goal was to expand capacity from 4 to 12 batches per month - a 3x increase - while also building the internal and external infrastructure to support this growth.
Key challenges included:
Selecting a hotel manufacturing partner with cell therapy experience and immediate availability
Retrofitting and validating Grade B cleanroom infrastructure
Equipping and operationalizing the site with GMP-compliant systems and documentation
Building a fully functional manufacturing and MSAT team
Executing a successful tech transfer and supporting the IND amendment submission
With our deep expertise in GMP facility startup and clinical operations, we delivered an end-to-end solution from site selection through to regulatory submission.
Conducted a rapid yet rigorous evaluation of potential partners
Selected a site based on staff experience in autologous cell therapy and operational readiness
Negotiated terms and aligned infrastructure requirements early in the process
Worked with the site to adjust the existing cleanroom layout and flow to fit the client’s process
Defined and executed equipment selection and qualification
Oversaw the validation of Grade B cleanrooms in line with GMP Phase 2 manufacturing requirements
Recruited and onboarded a 10-person manufacturing and MSAT team, from Director to operators
Facilitated cross-training and readiness for GMP operations
Deployed a fully electronic batch record system (MBRs) to support traceability and reduce manual errors
Authored all required SOPs and quality documentation
Implemented a fit-for-purpose quality system to support both clinical activities and future scale-up
Managed the entire tech transfer process, including analytical methods, raw material sourcing, and process comparability
Supported generation of the IND amendment for the expanded manufacturing site and batch capacity
> End-to-End Execution in 12 Months – From partner selection to IND amendment submission
> 3x Increase in Monthly Capacity – Scaling from 4 to 12 batches/month, fully validated and GMP-ready
> Operational GMP Facility – Fully equipped, staffed, and compliant with electronic MBRs and a complete documentation suite
> On-Time IND Amendment Submission – Enabled continued clinical dosing and accelerated Phase 2 enrolment
> Speed Doesn’t Require Compromise – With the right strategy and support, GMP manufacturing can be stood up rapidly without sacrificing quality
> Hotel Manufacturing is a Scalable Solution – A properly chosen and retrofitted hotel facility can bridge critical timelines in clinical development
> End-to-End Ownership is Key – Coordinating facility buildout, team recruitment, and regulatory strategy under one project umbrella streamlines delivery
This project demonstrated how a focused, strategic execution can deliver complex GMP infrastructure and capacity expansion in under a year. Our client entered Phase 2 with a robust, scalable manufacturing capability—positioned for future growth and clinical success.
A small biotech startup developing an autologous T cell therapy approached us for strategic guidance. At the time, they were in the early stages of raising seed funding and needed a clear roadmap to advance their product to clinical trials. The company faced key challenges, including limited internal expertise in CMC and regulatory strategy, and constrained funding.
The client needed a structured, milestone-driven plan that accounted for:
Preclinical validation requirements
Process and analytical development
Tech transfer into a GMP environment
Clinical manufacturing and operations
Regulatory milestones in both the U.S. and Canada
Additionally, the roadmap had to be designed with financial constraints in mind, ensuring activities were sequenced effectively to align with available funding.
To provide the client with a comprehensive strategy, we developed a CMC and Product Development Roadmap covering the entire journey from preclinical development to clinical trials. Our approach included:
Designed a phased preclinical validation strategy to ensure readiness for regulatory interactions
Incorporated early regulatory engagement through Pre-pre-CTA (Canada) and INTERACT (U.S.) meetings to derisk the clinical entry strategy
Established a framework for process development, ensuring the transition from R&D-scale to a scalable, GMP-compatible workflow
Defined key analytical methods to support product characterization and release testing
Mapped out the transition into a GMP manufacturing environment, identifying critical steps for a seamless tech transfer
Provided recommendations on suitable CDMOs and service providers, engaging them early in the process to align expectations
Developed a strategy for early clinical manufacturing, considering batch sizes, release criteria, and supply chain logistics
Outlined essential clinical operations requirements, including regulatory submissions, site selection, and trial execution
Assessed the client’s initial investor and clinical timelines and identified areas where expectations needed adjustment
Structured activities into distinct funding phases, prioritizing those critical for IND submission and clinical readiness
> Refined Funding & Investment Strategy – The roadmap provided a realistic timeline that allowed the client to refine their pitch to investors with a stronger CMC and regulatory foundation.
> Identified Key Service Providers – We evaluated potential CDMOs to ensure process scalability and GMP readiness.
> Strategic Execution Plan – With a structured roadmap in place, the client was able to align their internal team and external partners on clear next steps.
> Early Regulatory Engagement Saves Time – Proactive discussions with regulatory agencies helped refine the clinical and CMC strategy before IND submission.
> Phased Funding Approach Is Critical – Prioritizing essential CMC activities helped balance scientific progress with financial constraints.
> Select Service Providers Early – Identifying CDMOs and other partners in advance prevented delays in manufacturing readiness.
By partnering with us, the client gained a structured, strategic roadmap that set them on a realistic path toward clinical trials. This roadmap not only strengthened their investment pitch but also ensured that they were making informed decisions on process development, regulatory strategy, and clinical execution.
A biotech company developing an iPSC-derived allogeneic cell therapy and preparing for Phase 1 and Phase 2 clinical trials needed to identify a fit-for-purpose CDMO partner for clinical manufacturing. Given the complexities of iPSC-derived therapies - including scalability, regulatory requirements, and specialized GMP capabilities - the client required a structured, data-driven approach to evaluate and select a CDMO.
The client faced several key challenges in CDMO selection:
The need for a CDMO with specific expertise in iPSC-derived cell therapy manufacturing
Ensuring scalability from Phase 1 to Phase 2, with a potential path to commercial manufacturing
Evaluating the technical capabilities, regulatory compliance, and operational flexibility of different CDMOs across North America
Balancing cost considerations, quality standards, and long-term partnership potential
With 15 CDMOs identified as potential candidates, the client needed a rigorous selection process to narrow the field and secure the best fit.
To ensure a comprehensive and strategic data-driven CDMO selection, we implemented a multi-step process:
Conducted an initial market scan and contacted 15 CDMOs with expertise in iPSC-derived therapies
Assessed their capabilities, including:
> Experience with iPSC expansion & differentiation
> GMP facility readiness and regulatory track record
> Analytical testing and QC expertise
> Scale-up potential
Developed a detailed RFP capturing critical elements:
> Manufacturing processes & scalability
> Cost structure & tech transfer feasibility
> Quality systems & regulatory compliance (FDA, EMA, etc.)
> Timeline alignment with the client’s clinical program
Distributed a comprehensive Capability Questionnaire to assess GMP compliance, Regulatory history, Facility and Infrastructure, Digitalization, Manufacturing and QC Operations and Risk mitigation strategies
Conducted a Reference check with companies that had worked with the shortlisted CDMOs
Arranged on-site visits to evaluate manufacturing capabilities and team expertise firsthand
Facilitated final negotiations to ensure a strong contractual foundation and alignment on expectations
> Strategic CDMO Selection – The client successfully selected a high-quality CDMO partner that met technical, regulatory, and operational requirements.
> Risk Mitigation – A structured evaluation process minimized potential regulatory and manufacturing risks.
> Efficient Decision-Making – The rigorous selection framework helped the client move from 15 candidates using a data-driven approach.
> Long-Term Manufacturing Pathway – The selected CDMO provided a scalable solution from Phase 1 to Phase 2 with a future pathway to commercial manufacturing.
> A Structured RFP Process Ensures the Best Fit - A well-defined RFP and capability assessment streamline decision-making.
> CDMO Experience in iPSC Therapies is Critical - Not all CDMOs are equipped for iPSC-derived manufacturing; vetting their expertise early is essential.
> Site Visits & References Provide Deeper Insights - Technical capabilities on paper don’t always match real-world performance - on-site evaluations are critical.
By leveraging a structured, data-driven CDMO selection process, we enabled the client to secure a manufacturing partner aligned with their clinical and long-term commercialization strategy. The approach ensured quality, scalability, and regulatory readiness - key factors for a successful iPSC-derived allogeneic cell therapy program.
A Series A-funded biotech developing an allogeneic T cell therapy for autoimmune indications needed a detailed Cost-of-Goods (COGs) analysis to present to their Board of Directors. This analysis was critical for investment decisions and fundraising strategy, helping the company align its financial projections with future manufacturing and commercialization plans.
The client required a comprehensive, per-patient COGs breakdown to assess the financial feasibility of their therapy at different scales and dosing strategies.
The analysis needed to consider key cost drivers, including:
Raw materials (cell culture media, cytokines, viral vectors, etc.)
Labor costs at a CDMO
Facility and infrastructure expenses
Quality control (QC) and release testing
Logistics and cold chain considerations
Licensing fees for key technology partners (e.g., lentiviral vector licensing)
Clinical costs (including patient recruitment and site management)
Biomarker testing
Additionally, we needed to account for multiple production scenarios - evaluating how different dosing regimens (low vs. high dose) and production yields (low vs. high) impacted overall costs.
To ensure a comprehensive and actionable analysis, we built a structured tailored COGs model that:
Created a flexible framework allowing the client to compare low vs. high-dose treatment strategies
Modeled the impact of low vs. high-yield manufacturing scenarios at their selected CDMO
Developed a granular cost-per-patient breakdown, highlighting major contributors to manufacturing expenses
Quantified the cost differential between autologous and allogeneic approaches, reinforcing the economic advantage of their platform
Integrated CDMO-specific pricing into the model to reflect real-world cost structures
Delivered a tailored, adaptable financial model, enabling the client to update assumptions and integrate new data as their program evolved
> Confirmed Cost Advantage – The analysis demonstrated that their allogeneic model was ~5x cheaper per patient compared to autologous similar products, reinforcing the investment thesis.
> Data-Driven Decision Support – Provided a clear, board-ready financial analysis to guide investment and manufacturing decisions.
> Sustainable Financial Framework – Equipped the client with a structured tool to track costs over time and adapt as they progressed toward commercialization.
> Allogeneic Manufacturing Has a Significant Cost Advantage – The 5x lower per-patient cost supports long-term scalability.
> CDMO Strategy Impacts Overall COGs – Choosing the right partner and yield assumptions can make a major difference.
> Financial Models Need to Be Adaptive – A dynamic COGs model allows companies to refine cost assumptions as they advance toward commercialization.
This detailed COGs analysis provided the client an understanding of their commercialization position, supporting their Board discussions and investment strategy. By delivering a customizable model, we ensured they had a tool to continue refining their cost assumptions as the program evolved.
A clinical-stage CAR-T cell therapy biotech transitioning from GREX to a bioreactor encountered a critical issue: significant viability loss in their drug product. As they prepared for a Phase 2 trial, resolving this challenge was essential to ensuring a robust manufacturing process for regulatory submission.
Following the scale-up to a bioreactor, the client observed:
Increased apoptosis within the CAR-T cell population
Excessive activation leading to possible exhaustion
Low viability upon harvest, which was not seen in the original model
Given the complexity of bioreactor-based expansion, a thorough investigation was needed to pinpoint potential root causes.
With extensive expertise in bioreactors for cell therapy manufacturing, we conducted a systematic root cause analysis, evaluating key process parameters that could impact viability:
Investigated whether oxygen gradients or pH fluctuations were causing cellular stress
Adjusted setpoints to optimize environmental conditions
Analyzed how the media formulation and cytokine cocktail differed from the bag process
Identified key cytokine ratios that were driving overactivation and excessive proliferation
Adjusted cytokine levels to restore a balanced activation profile
Modified the media exchange and resuspension schedule to improve cell health
Conducted a Comparability Study in both bags and the bioreactor to validate findings
Iteratively optimized the process until viability and functional markers reached acceptable thresholds
> Restored Viability & Process Consistency – Implementing the revised process brought viability back into an acceptable range with greater run-to-run consistency.
> Regulatory Milestone Achieved – The optimized process enabled the client to submit their IND amendment for Phase 2 clinical trials.
> Stronger Manufacturing Strategy – The improved process provided a more scalable and controlled approach for future development.
> Bioreactor Optimization is Multi-Factorial – The transition from GREX to bioreactors introduces multiple variables that must be carefully controlled.
> Cytokine & Media Choices Matter – Small adjustments in cytokine cocktails can significantly impact cell expansion, activation, and viability.
> Thoroughly designed Comparability Studies Drive Faster Solutions – Direct comparisons with legacy processes help pinpoint root causes and accelerate troubleshooting.
By implementing a data-driven, multi-variable optimization strategy, we helped the client overcome a critical viability challenge and successfully advance their CAR-T manufacturing process. This case highlights the importance of bioreactor expertise, iterative testing, and strategic process refinements in scaling autologous cell therapies.
A large biotech developing a CAR-T cell therapy for Phase 2 clinical trials needed to identify the most fit-for-purpose bioreactor to support their automated, closed-system manufacturing strategy. With a long-term vision of decentralized manufacturing, the client required a structured approach to define the critical specifications that would guide their selection process.
Choosing the right bioreactor was a strategic decision that had to balance:
Automation & Ease of Use – Reducing manual interventions to align with decentralized manufacturing goals
Cell Viability & Phenotype Preservation – Ensuring that the CAR-T cells maintained their functional characteristics in an automated system
Cost-of-Goods (COGs) – Evaluating the financial impact of different bioreactor platforms
Scalability & Process Integration – Ensuring the bioreactor could transition from Phase 2 to later-stage manufacturing while remaining compatible with existing upstream and downstream process steps
Regulatory & Software Compliance – Assessing vendor capabilities, software platforms, and GMP-readiness
To ensure a data-driven selection, the client needed a comprehensive User Requirement Specification (URS) that would streamline their decision-making process and guide vendor engagement.
Leveraging our expertise in bioreactor selection for cell therapy, we developed a structured URS framework, ensuring that every aspect of process compatibility, scalability, and automation was addressed.
We worked closely with the client’s manufacturing, process development, and quality teams to outline key criteria for the bioreactor URS, focusing on:
> Automation & Closed-System Processing
> Cell Viability & Expansion Control
> Ease of Use
> COGs Considerations
> T Cell Phenotype & Functional Outcomes
> Regulatory & Software Integration
Conducted an in-depth comparative analysis of three bioreactor platforms that met the initial requirements
Assessed scalability potential to support both clinical and commercial manufacturing
Investigated software capabilities to determine integration feasibility with the client’s data tracking and automation systems
Factored in vendor GMP readiness, support infrastructure, and regulatory track record
Used the URS to drive a structured RFP process, ensuring vendors provided detailed responses aligned with the client's priorities
Conducted side-by-side data analysis to highlight strengths, weaknesses, and trade-offs of each platform
Enabled the client to make a streamlined, data-backed decision on the most suitable bioreactor
> Optimized Bioreactor Selection – The URS eliminated guesswork, leading to a clear and justified decision on the best fit-for-purpose bioreactor
> Accelerated Decision-Making – The structured approach streamlined the RFP process, reducing delays in vendor evaluation
> Scalability & Decentralized Readiness – The selected bioreactor met automation, scalability, and compliance needs, supporting future decentralized manufacturing goals
> Process Alignment for Phase 2 & Beyond – The bioreactor selection aligned with long-term process development strategy, ensuring continuity from clinical trials to commercialization
> A Well-Defined URS Ensures an Objective, Data-Driven Choice – Eliminating subjective decision-making reduces risks in manufacturing scale-up
> Automation & Software Integration Are Just as Important as Bioreactor Hardware – Ensuring compatibility with data tracking and regulatory compliance is critical for future scalability
> Long-Term Scalability Must Be Considered from the Start – Choosing a system that aligns with both Phase 2 needs and future commercialization goals prevents costly transitions later
By leveraging a structured, URS-driven selection process, we helped our client navigate the complexities of bioreactor evaluation - ensuring that they made a scalable, automation-ready, and regulatory-compliant decision that supports both Phase 2 clinical trials and long-term decentralized manufacturing goals.