ARTICLES BY TIM SANDLE
FDA Releases Guidance On Drug Products Containing Nanomaterials11/18/2022
In the FDA guidance entitled Drug Products, Including Biological Products, that Contain Nanomaterials, “nanomedicine” refers to a drug product that contains at least one component with a dimension in the size range of approximately 1 nanometer (nm) up to 100 nm. Focus of the guidance is on a risk-based regulatory strategy.
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.
Your Guide To Producing ADCs That Meet cGMP Expectations8/1/2022
Antibody-drug conjugates (ADCs) are a diverse class of biopharmaceuticals that combine highly selective monoclonal antibodies specific to surface antigens present on particular tumor cells. Discussion of current good manufacturing practices (cGMP) in this article includes containment, cleaning and decontamination, and manufacturing and purification.
mRNA Vaccines: Key Considerations For Development & Manufacturing4/4/2022
As we wind down National Immunization Awareness Month, this article looks at the complexities around developing and manufacturing mRNA vaccines and how you should address those complexities. Topics include delivery, process validation, long-term effectiveness, GMP, regulatory approval, and more.
The Current Landscape Of mRNA Vaccines In Clinical Research3/17/2022
With the Pfizer-BioNTech and Moderna products, mRNA vaccines made global headlines in 2021 in the fight against COVID-19. As we recognize National Immunization Awareness Month, this article shares how mRNA vaccines currently in clinical research and clinical trials may be soon used to fight HIV-1, herpes, cancer, and more.
What’s All The Hype About mRNA Vaccinology?3/7/2022
The COVID-19 mRNA-based vaccine success is spurring a further stream of medicines to come. This article provides an overview of mRNA for those who aren't already working in the field, how mRNA is being used in vaccines, and how mRNA can be used for future developments.
3D Printing For Pharmaceuticals & Medical Devices: A Primer With Risk Considerations1/28/2022
Implementation of single-use technologies for pharma and medical device manufacturing has introduced advantages in terms of design, sterility assurance, and a reduction in energy usage. 3D printing can deliver precise measurements to production facilities. This article describes the 3D printing process, risk considerations, and limitations — but the future is bright.
Risk Factors To Consider When Selecting Medical Devices For Pharmaceutical Applications10/22/2021
While risks can be reduced to a residual level, it is not possible to eliminate a risk entirely. Such risks are foremost about injury to the patient and to the user. Other associated risks may be to the environment or with any data collected. It is incumbent upon the purchaser or distributor to assess a new supplier of medical devices for the relative risk posed by these devices.
Prefilled Syringes: Best Practices For Using X-Ray Analysis To Assess Container Closure Integrity8/18/2021
The process of assessing integrity of the filled syringe is generally more complex than the process of assessing glass vials due to the presence of more sealing areas. This article looks at the broad requirement, together with a recent innovation for integrity testing based on X-rays.
10 Critical Validation Parameters For Microbiological Experiments7/26/2021
In studying a microbiological method, different validation parameters require assessment. These are variables or factors that can be controlled, changed, or measured in the experiment. This article outlines the key parameters to consider.