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Biotech Scale-Up in Record Time

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Biotech Company Scales and Commercializes Manufacturing in Record Time

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Life SciencesLife Sciences

Industry

Pharma Manufacturing

Location

United States

A fast-growing biotech company needed to scale up its early-stage production capabilities to meet strict GMP standards for commercial manufacturing. Trinity Consultants provided integrated design, engineering, commissioning, and validation support, helping the client expand capacity, ensure full cGMP compliance, and bring new products to market faster.

Challenge

A fast-growing biotech company needed to expand from pilot-scale production to full commercial manufacturing to keep pace with new product demand and market approvals. The transition required designing and building a new GMP facility that could maintain the highest standards of cleanliness, product safety, and regulatory compliance. This included multiple ISO-classified cleanrooms, robust environmental controls, and validated processes ready for FDA inspection. The client’s internal team lacked experience managing the complex integration of process scale-up, cleanroom design, commissioning, and qualification. Without specialized support, they risked costly redesigns, delays in facility approval, or gaps in cGMP compliance that could threaten commercial launch timelines.

Solutions

Trinity Consultants partnered with the biotech firm early in the project to guide each step of the scale-up and facility delivery. The team provided strategic input on GMP facility layout, cleanroom classifications, air handling systems, and utility requirements to meet stringent ISO standards. Detailed engineering reviews identified potential compliance gaps before construction, saving the client time and rework. Trinity developed a full Commissioning, Qualification, and Validation (CQV) plan covering equipment, processes, and environmental systems to align with FDA requirements. Expert teams oversaw cleanroom commissioning, validated air and process flows, and ensured all systems met strict cGMP standards. Trinity also trained client staff on operating procedures, cleanroom protocols, and documentation practices to maintain compliance long-term. By bridging technical design with regulatory execution, Trinity helped deliver a facility ready for commercial production, FDA inspection, and future scale-up.

Services Performed

The team provided cleanroom and GMP facility design consulting, supported process scale-up engineering, and led CQV planning and execution. They managed cleanroom commissioning and performance testing, offered regulatory guidance to meet cGMP standards and FDA expectations, and delivered stakeholder training with SOP development to ensure sustained compliance and operational excellence.

Results

As a result of Trinity’s support, the biotech company expanded its production capacity by 3x, moving from pilot-scale to full commercial manufacturing without costly delays. Multiple ISO-classified cleanrooms were designed, commissioned, and validated to meet international GMP standards and pass regulatory inspection. With Trinity’s comprehensive CQV program and technical oversight, the facility achieved 100% cGMP compliance from day one of operation. By addressing more than 50 critical design and process issues early, the client avoided expensive rework and brought its products to market faster — securing a strong return on investment and a foundation for future growth.

50+

Design/Process gaps resolved

3X

Capacity Expansion

100%

cGMP Compliance