FEATURE ARTICLES
As we close out the first quarter of 2023, let's take a look at how life sciences executives can conduct better M&A deals despite this unpredictable business environment.
- Navigating Claim Scope For Functionally Claimed Biological Compounds After Amgen v. Sanofi
- Dispelling 4 Common Myths Of Data Quality Governance
- Draft FDA Labeling Guidance Proposes More Clarity For Providers
- ICH Guideline Q9(R1) On QRM, Part 2: Subjectivity & Supply Continuity
- ICH Guideline Q9(R1) On QRM, Part 1: Formality & Risk-based Decisions
- Strategic Procurement For Emerging Pharmas & Biotechs
- Expanding Treatment Options With Oral Therapies For Immune-Mediated Inflammatory Diseases
GUEST COLUMNISTS
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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.
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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.
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Draft FDA Labeling Guidance Proposes More Clarity For Providers
The FDA's draft guidance for prescription and biologic drugs updates a 2010 guidance and comes following the boom of activity in the biologics space.
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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.
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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.
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Strategic Procurement For Emerging Pharmas & Biotechs
Emerging pharma and biotech companies depend significantly on suppliers, from initial discovery to clinical trials and regulatory approval. As a result, the sourcing and procurement function requires a strategic mindset aligned with business goals to drive an efficient purchasing process throughout the entire supply chain.
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Expanding Treatment Options With Oral Therapies For Immune-Mediated Inflammatory Diseases
One of the greatest advancements in treating immune-mediated inflammatory diseases (IMIDs) has been the advent of targeted biologic injectable therapies that target cytokines. However, oral cytokine inhibitors hold significant promise as next-generation options, offering the potential for improved safety, durability, and adherence.
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Resistance Or Defiance? The FDA And The 11th Circuit Spar Over Statute On Orphan Drug Statutory Exclusivity
Last September, the 11th Circuit Court of Appeals sided with a challenge to the FDA’s long-standing interpretation of the Orphan Drug Act by broadening the scope of orphan drug exclusivity under step one of the Chevron legal analysis. But the FDA has pushed back.
PHARMA ONLINE WHITE PAPERS
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5 Questions To Ask When Selecting An Advanced Analytics Solution For Process Manufacturing
New advanced data analytics have a huge positive impact on the growing volumes of data in many sectors. This white paper explores how to leverage these new analytics in process manufacturing.
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Why Perform A Product D-Value Study?10/5/2022
Follow our discussion on non-heat sensitive aqueous liquid products sterilized and the use of the Overkill method and Bioburden/BI method.
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An Introduction To High Voltage Leak Detection (HVLD) Technology4/8/2021
There are a variety of methods widely used in the detection of pinholes, cracks and defective seals in containers, but a majority are destructive causing the loss of product and packaging components.
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Components Of An Effective Disinfectant Prequalification Strategy1/24/2022
Cleaning procedures designed specifically to destroy microbial contaminants that may be present are an important component of any microbial control strategy.
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Modern Containment Solutions In OSD Processes12/14/2021
In the containment world for OSD processing we see smaller batch sizes and more changeover. Here we consider the pros and cons between hard-wall systems and flexible-wall containment systems.
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Biological Indicators And The European Pharmacopoeia5/10/2022
Here we review the information in European Pharmacopoeia (EP) General Chapter 5.1.2, concerning BIs, which is more detailed and covers a wider scope than the previous version.
PHARMA ONLINE APP NOTES & CASE STUDIES
- AAV Production In A Single-Use Bioreactor
- Genome Editing of Human Primary T Cells With Lipid Nanoparticles
- Particle Counting In Injectable Solutions
- Enabling Broader Adoption Of Process Intensification In Biopharma
- Effective Applicability Of The CentriPAK BioProcess Container In Mammalian CHO-S Cell Culture Separation
NEWSLETTER ARCHIVE
- 03.17.23 -- Strategic Procurement For Emerging Pharmas & Biotechs
- 03.16.23 -- Tangential Flow Filtration For Laboratory And Process Development Applications
- 03.16.23 -- ICH Guideline Q9(R1) On QRM, Part 1: Formality & Risk-based Decisions
- 03.15.23 -- Navigating Early Drug Development To Commercial Manufacturing
- 03.14.23 -- Formulation Development: Improving Solubility, Compliance, And Dosing Accuracy
PHARMACEUTICAL ONLINE CONTENT COLLECTIONS

What is Annex 1 and why is it important? What are the major changes? This e-book from Pharmaceutical Online, focuses on that the varying guidelines that will affect sterile pharmaceutical manufacturing operations.
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