Life Sciences

Process Development

Expert support for process and product development for clinical and commercial GMP processing.

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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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

Our team provides downstream process support, including these areas:

  • 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

Partnering with Trinity

Let’s collaborate. What can we help you achieve?

We invite you to contact us with your specific challenges. Let’s see how we can succeed together! Contact us to discuss how we can work together and achieve your goals. 

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