GMP Technology Transfer
The drug scale-up landscape has become increasingly complex in recent years, with evolving therapeutic pipelines, compressed timelines, and supply chain challenges.
To navigate these challenges, our Design Engineering and Technology Transfer (DETT) group, offers solutions that enable you to move and scale your therapeutic from API through finished dose with efficiency and speed.
HIPP’s Design Engineering and Technology Transfer (DETT) group is a high-performance project team that possesses a broad range of advanced therapy technical knowledge and cGMP manufacturing expertise. The DETT team understands that the “first to market advantage” is critical for our client’s success; therefore we provide dedicated professionals focused on supporting your strategic production goals at scale.
Whether you have a small molecule or large molecule project, our DETT solutions help you:
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Overcome complex formulation challenges during scale-up with simulation solutions to pinpoint the optimal process and equipment for production of your molecule.
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Address optimization challenges with modeling solutions to help you identify and resolve production bottlenecks.
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Navigate a complex regulatory environment, with experts to help you produce your product in the United States from preclinical to commercial volumes.
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Build success in early design development to enable commercial success, with integrated CQV plans that chart the best course accelerated validation.
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Shorten timelines to get to market quicker, relying on our unmatched global talent, technology, and best practices.
From process verification to pilot manufacturing and finally commercial cGMP-compliant production, HIPP’s team leverages a holistic quality-by-design approach (QBD) to provide each client with a robust tech transfer package that supports the executive mission.
Should your strategic objective involve:
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Leveraging contract manufacturing organizations (CMOs) to accelerate the introduction of new cell/gene therapy products to market.
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Using CMOs to reduce the cost incurred by having to build and validate a new facility
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Seeking a dual sourcing or reshoring strategy to mitigate product supply risks
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Rapid manufacturing scale-up to meet global market demand
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Optimizing an existing process.
Our application of a dedicated program manager and cross-functional technology transfer team ensures continuity and efficient use of intellectual capital throughout your project. HIPP’s application of knowledge-based systems technology to the domain of cGMP manufacturing ensures clients receive proven technical platform design and service excellence.
Pre-Transfer
Facility Capability Assessments (FCA) to identify gaps in the facility, equipment, and processes that might preclude effective tech transfer.
Scale Down Studies (SDS) to determine the most effective “path forward” for expanding the process design space, thereby enabling an effective tech transfer.
Pre-Scale
Feasibility Assessments (FA) to identify gaps in the facility, equipment and processes that might preclude effective manufacturing scale-up.
Pre-Transfer / Pre-Scale
Risk Assessment (RA) to determine single points of failure and prioritization of identified equipment and process gaps.
Transfer + Scale-ups
From early-stage development phases to commercial manufacturing.
Optimization Studies to determine production modification methods to achieve cost efficiencies.
Scale-ups
Engineering Designs to expand commercial-scale production in order to meet increased market demand.