Life Sciences
Process Development
The Advent Engineering team, part of Trinity Consultants, is routinely engaged for assistance in supporting process and product development for clinical and commercial GMP processing.
Experts in the commercialization of biopharmaceutical processes, our multi-disciplinary team is experienced in process scaleup, technology transfers, process modeling, optimization of small-scale processes; as well as analytical development and manufacturing technical support for commercial manufacture. Our experts are familiar with a wide range of modalities – from mature modalities like oral solid and liquid dosage and biologics, to advanced novel modalities such as cell and gene therapy. We provide end-to-end solutions to support our client organizations – from process development during clinical stages through commercialization of the drug substance or drug product.
Deep Expertise, Broad Spectrum of Services
In this video, Albert Dyrness, Managing Director, Trinity Life Sciences, discusses the Trinity Life Sciences difference.
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Related Services
Process Design
Expert design and engineering support for life sciences.
Project Management
Integrated project management services for pharmaceutical and biopharmaceutical sectors.
Commissioning, Qualification and Validation (CQV)
Prompt, knowledgeable CQV support for bio-pharma GMP manufacturing.Our Results
Featured Projects
Biotech Company Scales and Commercializes Manufacturing in Record Time
Advent enabled a biotech company to successfully complete technology transfer, while demonstrating comparability of process and product, in record time and within budget.
Advent Enables Manufacturing Flexibility for Biopharma Leader
Advent enabled a biopharma leader to position its manufacturing lines for greater flexibility for vaccine production, identifying opportunities to streamline to complete testing, commissioning and qualifying processes in a single month.
BioPharma Leader Scales Up Bioreactors Quickly and Cost-Effectively
Using computational fluid dynamics modeling (CFD) to simulate the fluid dynamics and working parts of a bioreactor, Advent enabled its client to optimize the design of bioreactors before they were built, mitigating risk and improving speed to market.Service Specifics
Process Development
Upstream Processes
Trinity’s Advent Engineering team assists clients with a wide range of upstream process development services, including:
- Conceptual design and modeling of process train from cell banking through harvest for transfer and scale up
- Host cell line development and cell culture development
- Media development and feeding strategy optimization for titer improvement
- HTST development for cell culture media
- Implementation of continuous cell culture systems based on perfusion
- Set up of harvesting/cell separation processes using filtration or centrifugation
- Identification and evaluation of critical process parameters (mixing, shear, and mass transfer)
- Development of single use systems for legacy and cell therapy processes
Downstream Processes
- Conceptual design and modeling of purification process train from harvest through bulk for tech transfer and scale up
- Design of chromatography skids capable of in-line dilution and real time chromatographic data analysis
- Buffer optimization and delivery
- Resin selection and optimization including static/dynamic binding studies
- Development of column packing procedures for compressible and incompressible resins
- Development of continuous chromatography based on expanded bed systems
- In-process controls methods development and validation including filter integrity testing
- Identification and evaluation of critical process parameters for chromatography, TFF, and bulk substances
- Implementation of viral inactivation and viral filtration for bulk including legacy processes
Fill-Finish Process Development
Our expert services in fill-finish process development include the following:
- Integration of isolators for integrated fill line including decontamination cycle development/validation
- Design and transfer of freeze-dried (lyophilized) drug products
- Development of depyrogenation cycles
- Evaluation of key lyophilization process parameters such as eutectic/collapse temperatures
- Evaluation of pump-based and time pressure-based filling processes