Drug Discovery Featured Articles & Applications
The Clinical Landscape Of ADCs In 2023: Diverse Technologies, Narrow Target
Antibody-drug conjugates (ADCs) are a type of targeted cancer therapy that combines the specificity of monoclonal antibodies with the potency of cytotoxic drugs. This article shares data surrounding the ADCs currently entering clinical trials, a look at failed ADC programs, and more.
Navigating Claim Scope For Functionally Claimed Biological Compounds After Amgen v. Sanofi
It can be difficult for broad biological compound claims to meet the two requirements in patent law that are used to “police” claim scope: the enablement requirement and the written description requirement. This article discusses the future of these types of patent claims after two Federal Circuit cases, Amgen v. Sanofi and Juno v. Kite.
Best Practices For Cell Culture Media Fingerprinting
This three-tier approach to cell culture media fingerprinting helps you to define an alternative method that will allow verification of the quality of the medium as well as fingerprinting. It helps you to choose suitable methods for incoming ID testing based on raw material properties, goals of media characterization, and the resources available.
Add Efficiency From Development To Validation With Design Of Experiments
A statistically-based design of experiments shortens development timelines while reducing product development and validation costs. This works by shrinking the total number of experiments required to evaluate parameters while strengthening analysis.
Dispelling 4 Common Myths Of Data Quality Governance
Achieving robust data quality governance doesn't need to be an unwieldy prospect. Here, we dispel the four common myths of data quality governance and share the three phases of a good data quality governance program.
Tackling Safety Issues Of Adjuvanted Vaccines
An adjuvant is a substance added to some vaccines to enhance the immune response and/or to reduce the number of doses required to achieve a protective effect. This article discusses the emerging use of adjuvants and assessing safety issues.
ICH Guideline Q9(R1) On QRM, Part 2: Subjectivity & Supply Continuity
The long-awaited revision to ICH’s harmonized tripartite guidance on Quality Risk Management, Q9(R1), was adopted on January 18. This article focuses on the guidance's new topics of subjectivity and the role of QRM in addressing product availability risks.
4 Lessons Learned Developing Cancer Immunotherapy Treatments
The ability to build up cancer-attacking T cells in cancer patients remains a major limitation of current immunotherapy approaches. PDS Biotech's CEO and CSO share four lessons they have learned along the way in developing their lead product, PDS0101, an immunotherapy targeting HPV-positive cancers.
Platforming Strategies To Increase Throughput With Better Standardization
Biologics development and manufacturing platforms should fit their target product profile. Here are four considerations for building more efficient platforms.
ICH Guideline Q9(R1) On QRM, Part 1: Formality & Risk-based Decisions
The long-awaited revision to ICH’s harmonized tripartite guidance on Quality Risk Management (QRM), Q9(R1), was adopted on Jan. 18, 2023. While the primary principles of QRM in this new version remain consistent with the original 2005 document, the revised guidance has four new subsections. This article examines the topics of formality and risk-based decisions.