ARTICLES BY TIM SANDLE

• Applying AI To Identify Synergistic Drug Combinations For Cancer Treatment

  3/14/2025

  By combining drugs/therapies with different mechanisms of action, different pathways in cancer cells can be targeted, potentially leading to improved patient outcomes. Using AI is hastening this research.

• How Can 3D Bioprinting Advance Drug Discovery?

  2/5/2025

  Biological printing (bioprinting; also called biofabrication) is a form of additive manufacturing that uses living cells, proteins, and nutrients as the basis of raw materials in pharmaceutical development.

• 5 Characteristics Of Forward-Thinking Microbiology Labs In 2025

  12/6/2024

  Improving microbiology laboratory efficiency is a continuum. Here are five tech-forward trends that will impact cost and efficiency in 2025.

• Improving Viral Safety: Highlights Of ICH Q5A(R2), USP, Ph. Eur. Recommendations

  8/6/2024

  ICH Q5A (R2) was released in Nov. 2023 and adopted by the FDA and EMA earlier this year. For a fuller assessment of viral control, compendia from the USP and European Pharmacopeia help.

• AI And Pharmaceutical Development: WHO Calls For Ethical Framework, Good Governance

  4/8/2024

  The World Health Organization (WHO) recently released a document titled Benefits and risks of using artificial intelligence for pharmaceutical development and delivery describing the ethical issues and governance considerations for using AI in drug discovery, preclinical development, and clinical trials.

• FDA Issues Draft Guidance For Cell & Gene Therapy Potency Assurance

  1/25/2024

  The FDA recently released a draft guidance, Potency Assurance for Cellular and Gene Therapy Products. This article summarizes the draft guidance. The public comment period ends March 27, 2024.

• Designing Facility Monitoring Systems For Cleanrooms

  12/4/2023

  Let's examine the features and advantages of facility monitoring systems, system architecture considerations, and overall system considerations.

• New ISO 14644-21:2023 Addresses Reducing Sampling Errors With Airborne Particle Counters

  9/11/2023

  The new ISO 14644 Part 21 addresses optimizing particle counter accuracy in cleanrooms, focusing on reducing sampling error and particle loss. Discussion includes the use of airborne particle counters, tubing, and isokinetic probes.

• CGMP Requirements For Automated Facility Monitoring Systems

  8/15/2023

  To assess facility control, most organizations use facility monitoring systems to monitor the manufacturing workspaces continuously. Let's take a deeper look at current good manufacturing practice (CGMP) requirements for the design and operation of such automated systems, including a look at total particle counting.

• Key Considerations In Selecting A Robotic Solution For Endotoxin Testing

  7/6/2023

  The U.S., European, and Japanese Pharmacopoeias require testing for bacterial endotoxin in pharmaceutical products, water, intermediates, and medical devices. This article shares key criteria for those of us who are looking to select an automated/robotic endotoxin detection system.

• FDA Adopts ICH Guidance On Assessing Nonclinical Biodistribution Of Gene Therapy Viral Vectors

  5/23/2023

  An important step in the gene therapy development process is assembling biodistribution data in suitable animals in relation to the intended clinical population. Developing an accurate biodistribution profile is influenced by factors such as the route of administration, dose level(s), dosing regimen, and the animal immune response to the gene therapy product. The FDA adopted this ICH guidance in May 2023, and the EMA plans to adopt it in September 2023.

• 5 Characteristics Of The Automated Microbiology Lab Of The Future

  4/24/2023

  The modern microbiology laboratory is starting to look very different from the laboratory of 10 years ago, and it will continue to evolve in the next few years. There are a number of innovations being implemented now or are in progress that can signal the path that many microbiology laboratories will follow.

• FDA Releases Final Guidance On Early-Phase Cell & Gene Therapy Trials

  1/18/2023

  The cell and gene therapy development process involves screening different variants of a product type. To aid this process and to ensure that suitable evidence is gathered so that effective variants of the product are taken through to later-stage trials, the FDA has produced a final guidance, Studying Multiple Versions of a Cellular or Gene Therapy Product in an Early-Phase Clinical Trial.

• ICH Issues Draft Guideline On Viral Safety Evaluation Of Biotech Products

  12/8/2022

  Viral contamination can affect raw materials, cell culture processes, bioreactor contamination, and downstream processing. ICH's new draft guideline titled Viral Safety Evaluation of Biotechnology Products Derived From Cell Lines of Human or Animal Origin is available for public comment through the FDA (ending Jan. 14, 2023) and through the EMA (ending Feb. 10, 2023).

• How Can Nanomedicine Innovations Combat Cancer?

  10/24/2022

  For the past two decades, nanotechnology has promised a revolution in medicine, especially in creating new ways to deliver medicines to treat cancer. This article shares an overview of nanomedicine and some of the key innovations within the field during the past year.