The Handoff Problem: Why Brilliant Science Still Stalls Before Commercial Launch
From lab-scale process development to commercial launch, biologics programmes touch dozens of disciplines. Here's how a single, integrated consultancy partner de-risks that entire journey.
Most biologics and biosimilar programmes don't fail because the science is wrong they stall because the handoffs are. A process that's beautifully characterised in the lab can still run into trouble at tech transfer, at PPQ, or during a CDMO negotiation, simply because no single team owned the thread connecting all of it.
That's the gap Graphtal is built to close. Below is a walk-through of the six areas where our team works alongside biopharma and biotech companies from the bench to the boardroom.
Process Development & Manufacturing
Everything starts with a process that's understood well enough to scale. This is where lab-scale science becomes a manufacturable, GMP-ready operation.
- Lab-scale and pilot-scale plant set-up
- Cell line development, including clonality documentation
- Process development for fed-batch, intensified, and perfusion modes
- GMP Master and Working Cell Bank manufacturing
- GMP drug substance manufacturing set-up
- MSAT support
- Tech transfer and scale-up
- Risk assessments, scale-down models & process characterisation
- PPQ runs, control strategy design & CPV
Scale-Up & Tech Transfer
Moving a process from a 2L bench reactor to a 2,000L commercial vessel isn't just "bigger" mixing, mass transfer, and hydrodynamics all change. Tech transfer is where good documentation becomes non-negotiable.
- Bioreactor scale-up from lab to pilot to commercial scale
- Engineering runs, scale comparability & process confirmation
- Mixing, mass transfer & hydrodynamic assessment at large scale
- End-to-end planning from originator to CDMO or new site
- Technology package prep: batch records, SOPs, process descriptions
- On-site & remote support during receiving-site qualification runs
- Risk-based tech transfer gap analysis & mitigation planning
- Product & process comparability protocols and reports (ICH Q5E)
- Regulatory CMC documentation support for BLA/MAA
Late Stage & Process Validation
By the time a process reaches validation, guesswork isn't an option. This is where the process must be defended with data a scale-down model that truly represents commercial scale, a control strategy built on real CPPs, and a validation package a regulator will accept.
- Design & qualification of miniature and benchtop SDMs
- SDM verification and scale comparability studies
- Risk-based SDM design for regulatory submissions
- Identification of CPPs and CQAs via risk assessment
- DoE strategy: establishment of PARs and NORs
- MVDA for multivariate process understanding & design space
- PPQ runs & process control strategy
- Continued Process Verification (CPV) & lifecycle management
- ICH Q8/Q9/Q10/Q11 compliance & regulatory filing support
Strategic Advice & Due Diligence
Not every question is a lab question. Boards and leadership teams need clear-eyed technical judgment before they commit capital whether that's expanding into biologics or evaluating an acquisition target.
- Biologics development & manufacturing requirements vs. corporate goals
- Support during portfolio expansion from small molecules to biologics
- Cost estimation & process economics
- Mentoring and training of management and technical staff
- Technical due diligence on investments in biotech companies or start-ups
- Technical due diligence on in-licensing of biopharmaceutical candidates
CDMO Support
CDMO relationships run both ways sponsors need an independent expert in their corner, and CDMOs themselves often need biologics-specific technical depth their internal teams don't have.
- RFP preparation, proposal review & comparison, CDMO selection
- Expert support of CDMO pre-clinical & clinical CMC programmes
- CDMO programme management
- Biologics expert advice for CDMOs, equipment & raw material suppliers
- Industry insight on raw materials, equipment & analytical methods
- Service provider surveys
Statistical Services
Underneath almost every deliverable above sits a statistical question. This is the analytical engine that turns raw process data into defensible, regulator-ready conclusions.
- Process development studies
- Scale-down model analysis
- Process characterisation
- Investigations
- Scale-to-scale comparison
- Annual Performance Quality Reports
- Method development
- Stability data analysis
- Method characterisation
- Accelerate bioprocess development with data-driven models
- Understand relationships between process variables and outputs to predict outcomes
Why One Integrated Partner Matters
Single Point of Accountability
One team that understands the process end-to-end not five vendors handing off partial context.
Faster Problem-Solving
Issues at tech transfer or PPQ get resolved by people who already know the process history.
Consistent Quality Standards
The same rigor from lab-scale DoE through to CPV, so nothing gets diluted in the handoff.
Reduced Tech-Transfer Risk
Statistically defensible scale-down models and comparability data, ready before regulators ask.
Have a process, molecule, or CDMO decision to work through?
Graphtal supports biopharma teams from early-stage development through commercial launch.
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Our team of experienced professionals at Graphtal is ready to transform your project from idea to reality, ensuring alignment with your organisation goals through advanced data analytics and predictive modelling.
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