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Biologics Manufacturing: Design & Build Out
Client Challenge
A European based company engaged in biological drug development was involved in an enormous undertaking when they contacted RCA. They were in the planning stage of a biologics manufacturing build for a new facility intended for their entire biologics production.
RCA Approach
RCA supported the design and assisted in the build out of both their microbiology and physical chemistry laboratories to support its up- and down-stream fermentation process.
RCA was contacted to provide the subject matter experts to review the conceptual designs for the following areas and supporting utilities; Facility; HVAC and cleanrooms; Compressed Air; Purified Water System; Extension of existing clean gases (N2, CO2 and O2); Extension of existing Water for Injection System; Environmental Monitoring System; Building Management System; Extension of Clean Media Automation System.
- RCA completed the design review and documented their findings in the form of a report. Items reviewed were listed as was the compliance status and risks. Noteworthy results of this engagement included:
- Recommendations for segregation of manufacturing activities, including pre- and post-viral inactivation sections analyzed with regard to air-handling systems, as well as movement of materials and personnel.
- Recommendations and findings for the GMP Water systems supporting each stage of the biologics facility manufacturing process.
- Recommendations and findings for the GMP Clean Steam systems supporting each stage of the manufacturing and sanitization processes.
- Review and recommendations regarding the Site Validation Master Plan.
Results
The outcome was a GMP compliant facility ready to undergo an FDA inspection. Jump forward to the present and the facility is now producing engineering batches.
In a subsequent engagement, the client asked RCA to provide interim temporary staff for a 3-month period. The positions RCA assisted the client with in terms of staff augmentation included, an Acting Director of Quality Assurance whose responsibilities were to review and approve the QMS policy and procedures, handle validation and qualification efforts and inspectional readiness.
Next was a Project Manager to report to the Quality Director. Key responsibilities included: development and maintenance of project schedules, tracking and reporting progress, roadblocks, etc.
Additionally, we placed a Quality Control Scientist to report to the Quality Director of the biologics facility. Their role was to develop methods and operational practices for QC labs, training QC staff as required and assist in the design and implementation of qualification studies, including environmental monitoring programs for all technical systems.
About RCA
Regulatory Compliance Associates® (RCA) provides regulatory compliance consulting to the following industries for resolution of life science challenges:
We understand the complexities of running a life science business and possess areas of expertise that include every facet of R&D, operations, regulatory affairs, quality, and manufacturing. We are used to working on the front lines and thriving in the scrutiny of FDA, Health Canada, MHRA and globally-regulated companies.
As your partners, we can negotiate the potential minefield of regulatory compliance and regulatory due diligence with insight, hindsight, and the clear advantage of our unique expertise and experience.
- Founded in 2000
- Headquartered in Wisconsin (USA)
- Expertise backed by over 500 industry subject matter experts
- Acquired by Sotera Health in 2021
About Sotera Health
The name Sotera Health was inspired by Soteria, the Greek goddess of safety, and reflects the Company’s unwavering commitment to its mission, Safeguarding Global Health®.
Sotera Health Company, along with its three best-in-class businesses – Sterigenics®, Nordion® and Nelson Labs®, is a leading global provider of mission-critical end-to-end sterilization solutions and lab testing and advisory services for the healthcare industry. With a combined tenure across our businesses of nearly 200 years and our industry-recognized scientific and technological expertise, we help to ensure the safety of over 190 million patients and healthcare practitioners around the world every year.
We are a trusted partner to more than 5,800 customers in over 50 countries, including 40 of the top 50 medical device companies and 8 of the top 10 pharmaceutical companies.
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