An appreciation

 

Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)

Best Merck webinars - 2025

 

Missed an interesting webinar recently? Check out this list of high quality webinars from Merck:

New EN ISO 7218 on General Requirements and Guidance for Microbiological Examinations in the Food Chain_Session 1

Updated standards for laboratory quality and compliance.
Watch Now >>

Ecomapping^® – A Practical Approach to Implement Sustainability in Your Lab

Practical methods to optimize resource use and sustainability.
Watch Now >>

Green Chemistry as the Foundation of Sustainability and the Circular Economy

Principles and applications of eco-friendly chemical synthesis.
Watch Now >>

The Art of Filtration 3.0

Advances in filtration technology for sample preparation.
Watch Now >>

Revolutionizing Therapeutic Development with Patient-Centric Models

Innovative cell culture models transforming drug development.
Watch Now >>

Expert Perspectives: Balancing Time and Contamination Risks in Sterility Testing

Strategies for contamination risk management and timelines.
Watch Now >>

The Power of Foundations – The Basics of IHC

Essential immunohistochemistry fundamentals.
Watch Now >>

Getting Equipped for the Future with the New MAS-100 Sirius^® Microbial Air Sampler

Latest equipment innovations for pharmaceutical production.
Watch Now >>

 

 

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)

Driving pharmaceutical quality with digital standards

 Image designed by Tim Sandle

Pharmaceutical manufacturing is digitizing and with this transformation comes the need for quality standards that can integrate with digital ecosystems. 

USP is updating Chapter 11 to address developments with digital standards. 

USP is evolving how qualitystandards are integrated into digital environments, bringing science-based rigor, regulatory confidence, and seamless connectivity to pharmaceutical workflows. By embedding digital reference standards and compendial methods into connected systems, USP helps manufacturers advance digitization without compromising quality. 

USP is helping organizations navigate transformation complexity and support integration of digital quality systems with trusted standards, validated methods, and collaborative innovation.

What are digital standards? 

USP digital standards are machine-readable digitally structured versions of established USP reference standards and test methods. Digital standards bring the same science-based rigor and confidence as USP’s physical standards but can be seamlessly integrated into digital workflows. 

Digital standards allow for: 

• Risk Mitigation & Traceability: Electronic capture of every step, version-controlled reference materials, and simplified reviews.
• Faster Tech Transfer: Standardized digital workflows and “digital twin” reference materials reduce variability across labs.
• Efficiency & Innovation: Automation and advanced analytics free resources and drive continuous improvement
• Why use USP digital standards?
• Regulatory uncertainty is the top barrier to adoption of digital standards. USP Standards are recognized and accepted by leading regulatory bodies and have been helping to ensure consistent quality across manufacturing sites, R&D facilities, and QC laboratories for more than 200 years. 

By evolving how these trusted standards integrate into digital environments, we can bridge science, regulation, and technology to ensure quality and increase confidence at every step. 

USP digital standards include: 

• dDS: USP digital Documentary Standards (dDS) are machine-readable in a validated, digital-first format, designed to power advanced laboratory workflows and enable the adoption of new technologies into quality systems.
• dRS: USP digital Reference Standards (dRS) are digital data demonstrated to have the appropriate qualities to support their intended use as references for comparison in compendial tests.

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)

Towards a 7-hour sterility test?

The 14-day turnaround time of current compendial sterility testing is plainly insufficient for a wide range of crucial, life-saving drugs and therapies, including an increasing number of novel cell and gene therapies which are incompatible with membrane filtration. As even slight contamination is unacceptable for parenteral treatments, this necessitates sterility tests that are not only faster than traditional methods, but as sensitive and accurate.

With an ever-increasing demand for faster sterility testing solutions, Alpha Laboratories is pleased to introduce the new RiboNAT™ rapid sterility test by FUJIFILM Wako. This test has been designed with rapid results in mind. It uses the Nucleic Acid Amplification (NAT) method, targeting ribosomal RNA (rRNA) and using RT-rPCR to deliver accurate results in just 7 hours. This test method boasts numerous benefits compared to other sterility tests – ribosomal RNA is present in higher relative quantities in microorganisms than genomic DNA, offering higher sensitivity (9 CFU/mL) while still detecting a broad range of bacteria and fungi. RiboNAT also significantly reduces false positives from dead microorganisms and residual DNA by inactivating and degrading DNA using nucleic acid inactivator and DNase.

The ability of RiboNAT to reliably and accurately detect a wide assortment of microbes in less than a day makes it an invaluable tool for validating and delivering drugs and therapies with short shelf lives, without having to administer at risk. This also seamlessly adds a crucial control point for sterility quality control into your workflow, with a simple and easy-to-learn testing process.

For further details, see: RiboNAT

 

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)

Europe's ATMP sphere - new insights

Image: Adoptive T-cell therapy. By Simon Caulton - Own work, CC BY-SA 3.0, https://commons.wikimedia.org/w/index.php?curid=29559885

During ESMO back in October 2025, more than twenty leading experts from Europe's ATMP sphere came together to discuss the key challenges the region faces developing and manufacturing novel therapeutics.

As a result of the discussion, a whitepaper written in collaboration between the Oslo Cancer Cluster and the Bayer CGT center has been published.

 

Advanced Therapy Medicinal Products (ATMPs) - insights by Tim Sandle

The guide can be accessed here. 

 

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)

Biopharmaceutical Development Market Expected to Exceed USD 124.6 billion by 2033

 

According to Research Intelo, the global biopharmaceutical development market size reached USD 54.8 billion in 2024, with a robust compound annual growth rate (CAGR) of 9.7% anticipated through the forecast period. By 2033, the market is expected to achieve a remarkable valuation of USD 124.6 billion. This substantial growth is primarily driven by the increasing adoption of advanced biologics, the expanding pipeline of novel therapies, and the rising prevalence of chronic and infectious diseases globally. The biopharmaceutical development market is witnessing dynamic transformation, with innovation, regulatory support, and technological advancements at the forefront of its expansion.

The Home Biopharmaceutical Development Market is an emerging frontier transforming how therapeutic solutions are researched, developed, and administered. Fueled by advancements in biotechnology, digital health, at-home diagnostics, and personalized medicine, this market represents a profound shift from traditional lab-centric drug development towards more accessible, patient-centric pathways. This article explores the major facets of this dynamic industry, framed under key themes of market drivers, technological enablers, challenges, and future directions.

Key Drivers Shaping the Market

Growing Demand for Personalized Medicine

Personalized medicine tailoring treatments to individual genetic and biological profiles has shifted from an aspirational goal to an industry standard. Biological therapies, such as monoclonal antibodies and gene therapies, are optimized for unique patient needs. This trend inherently requires frequent monitoring, adaptive dosing, and rapid feedback loops, making home-based approaches particularly desirable.

By enabling continuous data capture and individualized response tracking, home biopharmaceutical systems support precision therapy on a scale previously unattainable in traditional clinical environments.

Patient Preference and Convenience

Patients increasingly expect healthcare that fits into their lifestyles. Factors like transportation barriers, work commitments, and mobility challenges often hinder regular visits to clinics or labs. Home-oriented solutions reduce these burdens, improving patient engagement and treatment adherence critical determinants of therapeutic success, especially for chronic conditions like autoimmune disorders and cancer.

Technological Advancements Fueling Accessibility

Technological innovation is the backbone of this market. Three pillars stand out:

·         Connected Devices: Smart biosensors and wearable technologies continuously collect physiological data from heart rate variability to real-time biomarkers enabling remote monitoring and quicker intervention.

·         Telehealth Platforms: These bridge the gap between patients and healthcare professionals, facilitating remote consultations, data review, and decision-making without physical visits.

·         Advanced Manufacturing: Portable or modular biomanufacturing systems enable on-demand production of biologics or vaccines reducing dependency on large-scale central facilities.

Collectively, these technologies accelerate therapeutic timelines, reduce costs, and broaden access.

Market Challenges and Barriers

Regulatory and Safety Concerns

Biopharmaceuticals are inherently complex, and extending their development or administration to home environments raises regulatory questions. Agencies like the FDA and EMA emphasize stringent quality standards, remote data integrity, and patient safety monitoring. Ensuring compliance remotely particularly across jurisdictions remains a critical challenge.

Data Security and Privacy

Home biopharmaceutical systems generate vast amounts of personal health data. Protecting this information from breaches, while enabling real-time access for clinicians, requires robust cybersecurity infrastructure and strict privacy governance. Failure in this domain can erode patient trust and slow market adoption.

Technological Accessibility

Not all patients have equal access to digital infrastructure. Rural regions, low-income populations, and the elderly may face barriers due to limited broadband access, unfamiliarity with technology, or affordability issues. Bridging this digital divide is essential for inclusive market growth.

Future Trends and Opportunities

AI-Driven Therapeutic Optimization

Artificial intelligence and machine learning will play increasingly central roles in interpreting decentralized health data, predicting treatment responses, and optimizing dosing regimens all within home care frameworks. Intelligent algorithms can enable proactive intervention and personalized treatment pathways at scale.

Convergence of Biopharma and Consumer Health

As home biopharmaceutical models mature, the distinction between medical therapeutics and consumer health devices will blur. Wearables, wellness platforms, and home biopharmaceutical tools will form integrated ecosystems that support comprehensive health management from prevention to advanced therapy.

Expansion in Emerging Markets

Emerging economies present significant opportunities. Combined with mobile penetration and affordable diagnostics, home biopharmaceutical solutions can deliver healthcare in regions with limited institutional infrastructure. Local partnerships and adaptive business models will be key to realizing this potential.

Competitive Landscape

Prominent companies operating in the market are:

·         Pfizer Inc.

·         Roche Holding AG

·         Johnson & Johnson

·         Merck & Co., Inc.

·         Novartis AG

·         Sanofi S.A.

·         GlaxoSmithKline plc

·         AstraZeneca plc

·         AbbVie Inc.

·         Bristol-Myers Squibb Company

·         Amgen Inc.

·         Eli Lilly and Company

·         Gilead Sciences, Inc.

·         Biogen Inc.

·         Regeneron Pharmaceuticals, Inc.

Source: https://researchintelo.com/report/biopharmaceutical-development-market

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)