FDA's CDER has released a guidance sharing the agency's recommendations on how to evaluate out-of-specification (OOS) test results, including the responsibilities of lab personnel, the lab phase of the investigation, additional testing that may be necessary, when to expand the investigation outside the lab, and the final evaluation of all test results.
- FDA Publishes Guidance For Biopharma Container & Carton Label Design
- Assessing Extractables & Leachables In Parenteral Drug Products
- FDA Finds Drug Shortages Are Mostly Caused By Quality Issues
- AstraZeneca Implements A "Technology Uplift" Of Its Microbiology Labs
- Biopharma In China: The Emerging Global Force Of Domestic Suppliers
- Biopharma Partnerships: Key To Filling The Life Sciences Innovation Gap
- New ICH Q14 Guidance Applies QbD To Analytical Procedures
FDA Publishes Guidance For Biopharma Container & Carton Label Design
The scope of this new FDA guidance includes prescription drug products marketed under an approved NDA or ANDA, prescription drugs marketed without an approved application, and biological products marketed under an approved BLA. It does not directly apply to OTC drug products, compounded products, or investigational products, but the principles may still be useful to prevent improper use of those products.
Assessing Extractables & Leachables In Parenteral Drug Products
Therapeutic complexity increases the potential risks associated with chemical composition of materials used for drug packaging. Leachables in drug or biological products are chemical compounds that originate from components that are used to store and deliver medicines. Extractables should be considered as potential leachables.
FDA Finds Drug Shortages Are Mostly Caused By Quality Issues
New FDA guidance on risk management plans (RMPs) to mitigate the potential for drug shortages recommends an RMP for drugs that treat rare diseases and conditions, drugs with no alternatives, sole source products, products with only one API or manufacturing site available, and drugs made in facilities where an Official Action Indicated has been issued.
AstraZeneca Implements A "Technology Uplift" Of Its Microbiology Labs
Modern microbiology labs are busy, with a wide range of activities taking place from final product testing to auxiliary support such as quality control release checks on nutrient media. While instruments and equipment available to technicians can vary, AstraZeneca wanted a networkwide approach to modernizing its labs.
Biopharma In China: The Emerging Global Force Of Domestic Suppliers
Though multinational corporation vendors have seen double-digit pandemic-related sales increases for bioprocessing supplies in China, the top domestic vendors have posted even higher growth rates. With domestic supplier prices significantly cheaper, quite a few Chinese biopharma companies are shifting their purchase of supplies.
Biopharma Partnerships: Key To Filling The Life Sciences Innovation Gap
The life sciences industry is facing a significant slowdown due to patent expirations. Many organizations have not established a robust enough pipeline to overcome the revenue to be lost. To bridge this innovation gap, pharma CEOs will need to expand their use of alliances, in tandem with bolt-on M&A, as a pipeline booster strategy.
New ICH Q14 Guidance Applies QbD To Analytical Procedures
ICH's new draft guidance (Q14) for Analytical Procedure Development describes an enhanced approach for method development, validation, and life cycle management employing elements of quality by design (QbD) and risk management tools. This article also explains the differences between this enhanced approach and the traditional approach.
BIOSIMILAR WHITE PAPERS
8 mm Needle – Improving Subcutaneous Chronic Drug Delivery
Reducing needle length can improve the risk profile of subcutaneous injections and can make injecting viscous formulations easier and quicker.
A Guide To Accelerating Cell Line Development For Commercial Production8/11/2021
Explore the challenges associated with cell line development in the production of biologics, and solutions that can help biotech developers evade the pitfalls of misinformed decision-making.
Considerations For Improving Outcomes In Biopharmaceutical Process Development8/12/2020
In this article, we take a look at how the biopharmaceutical process outcome can be improved by increasing the performance and robustness of the bioprocess workflow through a variety of critical aspects, different strategic approaches, and innovative tools and methods.
Generating A Quality Attribute Profile For Antibody-Based Biosimilars: Assessing Differences In Fc-Associated Effector Functions4/13/2021
During biosimilar drug characterization, the use of orthogonal methods is necessary in providing a complete, detailed overview of the molecule being assessed – Surface Plasmon Resonance (SPR) assays allow for the description of an interaction by both kinetics and affinity, and are able to generate a wealth of information per sample assessment. Here, we review the use of the Sensorgram Comparison tool of the Biacore T200 software in two separate case studies, to detail instances where the affinity (KD) measurements and the binding responses did not sufficiently describe the drug substance interaction to the associated ligand.
Accelerate Process Intensification For Viral Vaccine Manufacturing7/23/2020
This article details an integrated portfolio of technologies to facilitate process intensification of viral-based vaccines including SARS-CoV-2 vaccine candidates.
From Cells To Organs – The Organoid Stepping-Stone8/13/2021
Human PSC-derived organoids have a promising future in many research and biomedical endeavors—from drug discovery to developmental biology.