Streamline decision making, reduce risk, and maintain regulatory alignment
From early formulation through commercial scale-up, we provide strategic and technical guidance to streamline decision-making, reduce risk, and maintain regulatory alignment. Whether you're building your clinical development plan, defining your Target Product Profile (TPP), or demonstrating process comparability, our team works across modalities and development stages to support faster timelines and smarter outcomes.
How we work
We know that formulation and scale-up are key areas of concern. That's why our team begins with a comprehensive product characterization, then applies DoE methods to develop and test optimized formulations. For clients scaling up for clinical trials, we tailor risk-based strategies to demonstrate process comparability and support regulatory submissions, avoiding delays and redundant studies.
Our approach combines deep technical knowledge with pragmatic execution. Each engagement typically includes:
Strategic planning for development milestones, regulatory submissions, and commercialization
Target Product Profile (TPP) definition and refinement to align product value with clinical and market objectives
Formulation development using structured Design of Experiments (DoE) to optimize stability, bioavailability, and shelf life
Scale-up readiness assessments to ensure process comparability and reduce risk of delay
Scale-up readiness assessments to ensure process comparability and reduce risk of delay
Protocol and study design support to integrate clinical, nonclinical, and CMC functions
Scientific advisory board coordination to guide key decisions and strengthen regulatory positioning
Case Study
Strategic scale-up and EMA compliance
A commercial-stage biopharma company developing a severe burn treatment needed to scale up its lyophilization process to meet growing market demand without triggering major capital expenditures or regulatory delays.
Harmony performed a full process assessment against EMA expectations and recommended a reconfiguration of single-use technologies upstream of the fill step. We designed a phase-appropriate process validation strategy, supported execution, and directly engaged with regulators to defend the approach.
$10M+
in avoided capital costs
10x scale-up using existing infrastructure
18-month
delay eliminated
EMA compliance secured without compromise to commercial supply chain integrity
VP of Manufacturing
Commercial Biopharma Company
"Harmony was able to come up to speed on our process very quickly and understood what we needed to change. They came up with a cost and time-saving solution to allow us to continue using our existing facilities without the need for costly new expansion. We were able to address our regulatory questions with no delays."
FAQ
Scaling up involves more than increasing batch size-it requires a comprehensive demonstration of process and product comparability, which may include manufacturing, analytical, and, in some cases, clinical or non-clinical assessments. The specific requirements depend on the product modality, the development phase, and the extent of the scale-up. This includes alignment with regulatory expectations, detailed documentation, and risk-based justification to support continued safety and efficacy.
Formulation development begins with a thorough characterization of the product's physical and chemical properties. Based on this assessment, a structured experimental plan-often leveraging a Design of Experiments (DoE) approach-is implemented to identify optimal formulation conditions. This is followed by stability studies and a comparability assessment to ensure that product integrity and performance are maintained or improved under the new formulation.