NEWS

How successfully implementing alternative sterility tests can achieve a ~50% reduced incubation time

1 March 2023
Fill Finish
Margit Franz-Riethdorf
Global Change Facilitator

The current compendial sterility test has a 14-day incubation time and is often the time-limiting step in the ‘assess and release’ process of pharmaceutical products. There is an ever-increasing number of alternative sterility test systems available that have benefits in addition to faster time-to-result, such as standardization and automation of readouts (eliminating analyst subjectivity) and improved data integrity (e.g., eliminating the need for concurrent verification of results by another analyst). 

Regulators have been encouraging the industry to adopt these innovative systems and, nowadays, there is an increasing number of approvals from various health authorities (including the FDA and EMA) for using an alternative and rapid sterility test for releasing sterile drug product lots. 

This is why BioPhorum’s Alternative and Rapid Microbial Methods team has written an article on Rapid Sterility Test Systems in the Pharmaceutical Industry: Applying a Structured Approach to their Evaluation, Validation and Global Implementation.

Published in the PDA Journal of Pharmaceutical Science and Technology, the team describes a systematic, nine-step approach for the evaluation, equipment qualification, validation, and deployment of alternative sterility tests. To take advantage of the numerous benefits of alternative sterility tests, the following nine steps are recommended:

1: Identify operational/business need 

2: Define the application 

3: Assess requirements 

4: Compare options and technologies: landscaping and candidate(s) selection 

5: Develop a business case: technical, quality, and business evaluation and justification 

6: Perform proof-of-concept studies/feasibility studies/pre-validation studies 

7: Validate at pilot or primary site 

8: Deploy global/company-wide qualification of additional laboratories 

9: Define regulatory filings and implementation strategy.

Two case studies illustrate possible validation and implementation approaches, including statistical methods. These cover a respiration-based alternative sterility test and an adenosine triphosphate bioluminescence-based alternative sterility test in liquid growth media. 

While most of the steps towards implementation are aligned, the method validation and transfer have been approached differently for each case study because of differences in the chosen technologies and the companies’ internal strategies to validate and roll-out the new method. However, both case studies show a successful implementation of an alternative sterility test for sterile drug products with an ~50% reduced incubation time.

The special feature of the systematic, nine-step approach is that it can be used for many applications. BioPhorum has already used it to create technical papers for Automated Colony Counting Systems and PCR-based Mycoplasma Detection Methods, which follow the nine steps. Now this ubiquitous approach has been successfully used for alternative sterility test systems. The unique value of this paper lies in the insight into how guidelines have been translated into a detailed validation and deployment approach by two companies, as seen in the case studies.

Green And Yellow DNA Chains
NEWS
Adopting BFPC systems: how BioPhorum is increasing the pace of change
abstract yellow and green patterns
NEWS
Is it time we revisit regulatory expectation that we obtain microbial identifications when using a non-growth-based monitoring method?
Colourful Arrows
NEWS
Why BioPhorum’s modern microbial methods evaluation roadmap is a foundation for success
Colourful Arrows
NEWS
The non-equivalency of the CFU with the AFU – the challenges.
Colourful Bateria In Petri Dishes
NEWS
Reducing human error through automated colony counting systems

Advanced Therapy Medicinal Products

Advanced Therapy Medicinal Products support the quest for better and faster development of cell, gene and RNA therapies​ through connecting therapy developers, contract manufacturing, and testing organizations to gain an understanding and respond to the challenges faced by the advanced therapeutics industry.

Development Group

Development Group accelerates and improves the development process of biopharmaceutical medicines for the benefit of the patient. Replacing isolation with collaboration by providing a “safe” space where subject matter experts can work on sharing solutions and best practice on emerging industry trends, implementation of new technologies and common issues whilst ensuring their intellectual property and confidentiality is protected.

Drug Substance

Drug Substance advances excellence in drug substance manufacturing and testing, acting as an industry voice to accelerate technology adoption, implement post-approval change more rapidly and increase confidence in maintaining compliance.

Fill Finish

Fill Finish accelerates development and acceptance of sustainable world-class filling and packaging operations for drug product which meets the future needs of patients. Through innovative solutions resulting from the sharing of expertise, we can overcome common performance challenges and deliver on quality and regulatory compliance.

Information Technology

Information Technology accelerates digital maturity across the ​global pharmaceutical manufacturing industry.

Quality

BioPhorum Quality provides a dedicated, safe space for quality professionals from biomanufacturers and contract organizations to coalesce and enhance effective collaboration to address shared industry challenges.

Regulatory-CMC

Regulatory CMC brings leaders together who have a common goal – to improve access to medicines through innovation in the Regulatory ecosystem. It provides a dedicated space for strategic leadership and a coordinated industry voice, to move from divergence to convergence.

Supply Chain to Patient

Supply Chain to Patient transforms the performance of global pharmaceutical clinical and commercial outbound supply chains through industry collaboration by creating transparent patient-centric, resilient and agile E2E supply chains, that consistently deliver high-quality medicines ensuring an uninterrupted supply to patients.

Supply Partner

Supply Partner is a trusted advisory group and collaboration that is the engine for driving change across the global industry for all things relevant to the inbound supply chain. Addressing the challenges of complexity, resilience, cost, sustainability, and innovation.

Sustainability

Sustainability enables the industry’s transition to a low carbon, circular future – supporting members to improve patient health while respecting the planet. We activate multi-disciplinary teams drawn from our network to deliver environmental sustainability improvements across the value chain.

Technology Strategy

Technology Strategy acts as one voice of the industry to define strategy, accelerate technology transformation and support technology translation and adoption. With a purpose of enabling the future state of flexible, resilient, sustainable end-to-end biomanufacturing.

DOWNLOAD
An industry perspective on understanding AAV capsid content variants
Needle On Yellow Background
EXTERNAL-RESOURCE
An intercompany perspective on practical experiences of predicting, optimizing and analyzing high concentration biologic therapeutic formulations
DOWNLOAD
The Drug Substance 2.0 Strategic Value Framework
Coloured dots on teal, next to vial
DOWNLOAD
BioPhorum’s holistic approach to container closure integrity
Magnifying glass over a tablet all coloured blue
DOWNLOAD
Digital Plant Maturity Model 3.0
NEWS
Inaugural BioPhorum Quality face to face – get involved
PODCAST
The next step in building regulatory as a capability to enable strategic innovation across the BioPhorum community
PODCAST
Delivering a Cell and Gene Therapy Outbound Supply Chain Pathway for the Industry
DNA and Earth on blue background
DOWNLOAD
A vision for the biopharmaceutical industry’s inbound supply chain
NEWS
A major milestone – a harmonized approach to product carbon footprint data
Technology Roadmap V 2.0
DOWNLOAD
BioPhorum Technology Roadmapping roadmap vision 2.0

Publications

Documents including best practices, vision statements and peer reviewed papers to help you take value back to your business.

Webinars

Discussing all aspects of the biopharmaceutical industry, from digitization and knowledge management to raw materials, supply chain, sustainability and more. Learn from the perspectives of those at the forefront of the industry.

Podcasts

BioPhorum Connect is our podcast series that keeps you up to date with the latest news and trends in the biopharmaceutical industry. From experienced professionals to thought leaders, these podcasts bring you the insights and perspectives of experts from around the world.

Tools

A variety of resources including design tools and user requirement specifications to help you improve and streamline your business processes.

Benchmarks and Surveys

Research conducted among the BioPhorum membership providing evidence to support change and identify best practice.

Browse all

Access a variety of free tools and papers and other resources designed to provide you with up-to-date information and insights to help you make informed decisions and maximize your success. Access our resources today and start making improving and streamlining your business processes.

WEBINAR
Bioreactivity testing in single-use system biomanufacturing
WEBINAR
Bioreactivity testing in single-use system biomanufacturing
WEBINAR
Bioreactivity testing in single-use system biomanufacturing
Magnifying glass over a tablet all coloured blue
DOWNLOAD
Digital Plant Maturity Model 3.0
WEBINAR
Bioreactivity testing in single-use system biomanufacturing