News | Pharmefex

6/29/26

The FDA is Defining Genome Editing Safety

6/17/26

Bispecific antibodies are an expanding therapeutic approach with a key challenge in CMC

6/10/26

CAR-T Meets LNP: A Familiar Platform with a New CMC Challenge

5/25/26

CGT Regulatory Flexibility and Global Harmonization

5/22/26

mRNA/LNP Manufacturing: From Pandemic Platform to Industrial Discipline

5/15/26

ADCs: A Deeper Look at Antibody-Drug Conjugates and Why CMC Preparedness Is Everything

5/15/26

ADCs: Why the Most Exciting Modality in Oncology Is Also the Most CMC-Demanding

1/28/26

ADCs: Manufacturing Challenges and Opportunities

1/21/26

Early CMC readiness is front and center across the entire industry

1/12/26

Supply chain resilience is becoming a manufacturing footprint decision

1/5/26

CDMO strategy is one of the most important levers in CMC

9/30/25

Pharmefex Brief on FDA PreCheck and AMT

7/16/25

What the HHS Layoffs Mean for Biotech and What Companies Should Do Now

6/12/25

Why Including Pregnant Women in Clinical Trials Is Essential for Ethical and Effective Drug Development

6/10/25

Why Biotech Developers Must Act Now on Nitrosamine Risk Management

6/4/25

Why Outsourced Project Management and Regulatory Compliance Are the Future of Biotech

5/21/25

The Rise of ADCs. Why Outsourcing and Supply Chain Diversification Are Critical to Success

5/13/25

Navigating the Complexities of CMC Strategy in Cell and Gene Therapy Development

4/30/25

FDA Endorses Shift Toward Non-Animal Testing. A Transformative Step in Drug Development

4/22/25

ICH Publishes Revised Q1A(R3) Stability Guideline: Strategic Considerations

Latest News

The FDA is Defining Genome Editing Safety

Bispecific antibodies are an expanding therapeutic approach with a key challenge in CMC

CAR-T Meets LNP: A Familiar Platform with a New CMC Challenge

CGT Regulatory Flexibility and Global Harmonization

mRNA/LNP Manufacturing: From Pandemic Platform to Industrial Discipline

ADCs: A Deeper Look at Antibody-Drug Conjugates and Why CMC Preparedness Is Everything

ADCs: Why the Most Exciting Modality in Oncology Is Also the Most CMC-Demanding

ADCs: Manufacturing Challenges and Opportunities

Early CMC readiness is front and center across the entire industry

Supply chain resilience is becoming a manufacturing footprint decision

CDMO strategy is one of the most important levers in CMC

Pharmefex Brief on FDA PreCheck and AMT

What the HHS Layoffs Mean for Biotech and What Companies Should Do Now

Why Including Pregnant Women in Clinical Trials Is Essential for Ethical and Effective Drug Development

Why Biotech Developers Must Act Now on Nitrosamine Risk Management

Why Outsourced Project Management and Regulatory Compliance Are the Future of Biotech

The Rise of ADCs. Why Outsourcing and Supply Chain Diversification Are Critical to Success

Navigating the Complexities of CMC Strategy in Cell and Gene Therapy Development

FDA Endorses Shift Toward Non-Animal Testing. A Transformative Step in Drug Development

ICH Publishes Revised Q1A(R3) Stability Guideline: Strategic Considerations

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