Blog Posts

The Synergy of Structural and Functional Analysis in Biosimilar Development

Wednesday 7th October 2026

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Is there commercial value in testing products in early-phase development?

Wednesday 30th September 2026

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High-throughput analytical strategies for integrated biotherapeutic characterization

Wednesday 23rd September 2026

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Making data-derived early decisions regarding biopharmaceutical product development

Wednesday 9th September 2026

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Protein Sequencing by Mass Spectrometry: Differentiating Leucine and Isoleucine

Wednesday 5th August 2026

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Regulatory Considerations for the Analysis of Peptide Products

Wednesday 29th July 2026

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Guest Blog: Analytical Characterization of Synthetic Peptides – Implications of the New EMA Guideline

Wednesday 15th July 2026

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Expert Opinion Blog: EMA Reflection Paper on Biosimilars: An Analytical Perspective on the Shift Away from CES

Wednesday 8th July 2026

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Guest Blog: FDA’s Revised Biosimilar Q&As: Reinforcing the Central Pillar of Analytical Characterization

Wednesday 1st July 2026

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FDA-Approved Antibody Drug Conjugates: What Today’s ADC Approvals Mean for Developers

Wednesday 24th June 2026

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Antibody Drug Conjugate Manufacturing: Process, Challenges, and Emerging Trends

Wednesday 17th June 2026

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What Are Product and Process-Related Impurities? (Definitions, Examples, and How to Interpret Them)

Wednesday 10th June 2026

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Protein Structural Characterization Techniques: A Strategic Guide for Biologics Development

Wednesday 3rd June 2026

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Peptide-oligonucleotide Conjugates: Structural Insights, Key Differences, and Analytical Challenges

Wednesday 27th May 2026

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Forced Degradation Guidelines: How to Design an ICH-Compliant Study for Biologics

Wednesday 20th May 2026

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Peptide Mapping in Biopharmaceutical Analysis: A Comprehensive Structural Tool

Wednesday 6th May 2026

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AAV Vector Gene Therapy: What It Is, Key Trends & Why Analytical Data Matter

Wednesday 22nd April 2026

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What Is a Signal Peptide? Function, Structure, and Role in Biopharmaceuticals

Wednesday 15th April 2026

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How Does Glycosylation Affect Protein Function? A Practical Guide for Biologic Development

Wednesday 8th April 2026

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Higher Order Structure and Aggregation Analysis of Antibody Drug Conjugates (ADCs)

Wednesday 25th March 2026

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Therapeutic Conjugates – New Tools in the Arsenal for Cancer Treatment

Wednesday 18th March 2026

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Therapeutic Biopharmaceutical Conjugates: From Laboratory to Market – a Regulatory Maze?

Wednesday 11th March 2026

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Use of Linkers in Therapeutic Conjugates

Thursday 5th March 2026

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X-Drug Conjugates (XDCs): The Next Generation of Targeted Therapeutics

Wednesday 18th February 2026

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From ADCs to XDCs: The Evolution of Conjugate Therapeutics

Wednesday 11th February 2026

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Analytics of Therapeutic Conjugates

Wednesday 4th February 2026

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How Antibody-Drug Conjugates Work: Mechanism of Action and Analytical Considerations

Friday 30th January 2026

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Peptide Mass Fingerprinting vs Peptide Mapping: Key Differences and Applications

Thursday 29th January 2026

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How to Prevent Protein Aggregation: Insights and Strategies

Tuesday 20th January 2026

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Oligonucleotide Synthesis: What It Is, How It Works, and Why It Matters

Monday 5th January 2026

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Residual Polymer Analysis: Crucial for Securing Product Safety, Quality and Performance

Wednesday 10th December 2025

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Expanding the Regulatory Shift: FDA Removes Clinical Efficacy Studies (CES) for All Biosimilars

Wednesday 3rd December 2025

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Groundbreaking Changes in Biosimilar Regulation in the USA

Wednesday 1st October 2025

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What Are the Differences Between Monoclonal and Polyclonal Antibodies?

Tuesday 23rd September 2025

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What Are Host Cell Proteins in Biologics Development?

Friday 29th August 2025

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Guest Blog: Recent Global Biosimilar Regulatory Advances

Wednesday 6th August 2025

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Deeper Peptide Insights: Use of the Waters Cyclic Ion Mobility Mass Spectrometer in Structural Analysis of Proteins and Peptides

Wednesday 23rd July 2025

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Peptide Conjugates as the Next Generation Therapeutic Modality

Wednesday 16th July 2025

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Peptidomics – Spotlight on Endogenous Peptides

Wednesday 18th June 2025

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Product-Related Impurities in Peptides: Analytical Insights and Best Practices

Wednesday 11th June 2025

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Process-Related Impurities in Peptides: Key Considerations and Analytical Approaches

Wednesday 4th June 2025

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Considerations for Advanced Peptide Analysis in Drug Development

Wednesday 28th May 2025

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Guest Blog: Everyone’s Talking About Nitrosamine Drug Substance Related Impurities (NDSRIs)! – Dr. Fiona Greer

Thursday 8th May 2025

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Modern Delivery Systems for Oligonucleotide Therapeutics

Wednesday 7th May 2025

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Solving the Puzzle of Oligonucleotide Stereoisomers: Robust Strategies for Successful Analysis and Characterization

Wednesday 30th April 2025

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Oligonucleotide Conjugates at the Forefront of Next-Generation Therapeutic Modalities

Wednesday 23rd April 2025

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Analysis of Process-Related Impurities in Oligonucleotide Products

Wednesday 16th April 2025

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Characterizing Oligonucleotide Impurities: Analytical Strategies and Regulatory Guidelines

Wednesday 9th April 2025

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Higher-Order Structure (HOS) Characterization of Oligonucleotides: Analytical Techniques and Considerations

Wednesday 2nd April 2025

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Innovative Solutions in Phosphorodiamidate Morpholino Oligomers (PMOs) Sequencing for Oligonucleotide Therapeutics

Wednesday 26th March 2025

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Oligonucleotide Structural Analysis – Sequencing Strategies and Mass Spectrometry Approaches

Wednesday 19th March 2025

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Navigating the Complexities of Oligonucleotide Analysis: Challenges and Solutions

Thursday 13th March 2025

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Using the Power of Mass Spectrometry to Characterize Oligonucleotides

Tuesday 25th February 2025

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Nitrosamine Testing in Biopharmaceuticals: A Critical Component of Product Safety and Regulatory Compliance

Tuesday 14th January 2025

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Driving Innovation in Biopharmaceutical Characterization: BioPharmaSpec’s New Facilities and Advanced Instrumentation

Thursday 12th December 2024

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Revolutionizing Secondary Structure and Stability Measurements at BioPharmaSpec

Thursday 14th November 2024

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The use of Evaporative Light Scattering Detection (ELSD) in Residual and Impurity Testing

Tuesday 8th October 2024

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L- and D-Amino Acids: Are They Different and Does it Matter?

Monday 16th September 2024

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EMA “Report Card” 2023

Monday 12th August 2024

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Bioinformatics at BioPharmaSpec: Adding value to your structural characterization projects

Monday 8th July 2024

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Robust Considerations

Wednesday 12th June 2024

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Biosimilar milestones in the US

Thursday 23rd May 2024

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Emerging Oligonucleotide-based Drugs 

Thursday 11th April 2024

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Empowering Future Innovators – A Personal Perspective

Tuesday 19th March 2024

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Are We Approaching a Biosimilars Boom?

Thursday 22nd February 2024

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Searching for sites of glycan attachment

Tuesday 16th January 2024

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Is the Future Bright for Well-Known Biosimilar Blockbusters?

Thursday 21st December 2023

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Understanding the “interchangeable” biosimilar designation

Friday 17th November 2023

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Hunting Host Cell Proteins (HCPs) with Mass Spectrometry

Tuesday 31st October 2023

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Process Related Impurities: Looking Beyond the API for Safer Biotherapeutics

Friday 29th September 2023

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Using Glycan Data to Predict Functionality and Shape PK Studies

Thursday 24th August 2023

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BioPharmaSpec – a fully integrated extension of your analytical capabilities

Monday 10th July 2023

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Amino Acid Analysis: an essential technique for the analytical lab

Friday 16th June 2023

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Being BioPharmaSpec Newbies: Experiences Gained in Our First 9 months

Wednesday 26th April 2023

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Intact Mass: A Simple Analysis?

Tuesday 14th March 2023

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Q&A Session with Biosimilar Roundtable Panelists – Dr Andrew Reason

Friday 24th February 2023

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Glycosylation in Plants- a barrier to Plant Molecular Farming (PMF)?

Thursday 12th January 2023

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Considerations for the Analysis of Glycans from Different Cell Types

Tuesday 20th December 2022

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Evolution of ICH Q2 guideline (Validation of Analytical Procedures)

Tuesday 29th November 2022

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Analytical Quality by Design – What’s it all about?

Thursday 27th October 2022

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Knowledge-based Structural Analysis of Biopharmaceuticals

Wednesday 28th September 2022

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Q&A Session with Biosimilar Roundtable Panelists – Dr. Dan Mamelak

Tuesday 23rd August 2022

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Q&A Session with Biosimilar Roundtable Panelists – Dr Marius Schmid

Tuesday 23rd August 2022

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Q&A Session with Biosimilar Roundtable Panelists – Dr Richard Easton

Tuesday 23rd August 2022

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Q&A Sessions with Biosimilar Analytical Experts

Monday 22nd August 2022

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O- Glycan Characterization: small but mighty glycans!

Wednesday 17th August 2022

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The Need for Orthogonal Methods in Higher Order Structure (HOS) Analysis

Thursday 30th June 2022

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Should methods be qualified for biosimilar structural characterization?

Friday 27th May 2022

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Forced Degradation Studies: Why, What and How

Friday 29th April 2022

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Expert Opinion: Connecting Scientific Expertise and Data Processing Software

Wednesday 9th March 2022

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The Case for Orthogonal Aggregation Analysis

Thursday 3rd February 2022

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Structural Analysis of Novel Chemistries

Wednesday 19th January 2022

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CE-SDS: Old Dog, New Tricks?

Wednesday 19th January 2022

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Oligonucleotide-based Drugs: a Promising Class of New Therapeutics?

Thursday 2nd December 2021

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Thinking About LC-MS for HCP Quantitation?

Tuesday 23rd November 2021

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Analysis of Adeno-Associated Virus (AAV) Capsid Proteins

Friday 13th August 2021

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Two Steps Forward for Biosimilars in the US: The Approval of Interchangeable Semglee®

Wednesday 11th August 2021

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“Gene Therapy – Game changer treatments” – Dr. Fiona Greer

Friday 4th June 2021

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Guest blog: “US FDA Biosimilar Regulatory Developments in 2020”- Dr. Fiona Greer

Thursday 1st April 2021

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Dealing with the Challenges of Disulfide Bridge Analysis in Biopharmaceuticals

Wednesday 17th March 2021

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Guest blog: “A Brexit Bonus for Biosimilars in the UK?” – Dr. Fiona Greer

Thursday 21st January 2021

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Dealing with the challenges of N-glycan structures in complex glycoproteins

Wednesday 13th January 2021

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Guest Blog: “Analytical R&D: Thoughts on Outsourcing vs In-house” – Dr. Fiona Greer

Wednesday 13th January 2021

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Building Orthogonality into Your Analytical and Characterization Plans – Part 2

Friday 20th March 2020

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Building Orthogonality into Your Analytical and Characterization Plans – Part 1

Monday 24th February 2020

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Biosimilar Testing: Structural and Physico-Chemical Comparability Analysis

Thursday 30th January 2020

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Protein Characterization Services to Support the Development of New Biopharmaceutical Products

Friday 13th December 2019

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