Biotechnology (Biotech) is the application of biological systems and organisms to technical and industrial processes. Pharmaceutical biotechnology is a relatively new and growing field in which the principles of biotechnology are applied to the development of drugs. Most therapeutic drugs in the current market are bioformulations, such as antibodies, nucleic acid products (e.g., mRNA), and vaccines.
PE Articles
Single-Use Technology Waste in Manufacturing Operations
Single-use products used in the production of biologics provide flexibility that was unimaginable a…
PE Articles
3R Initiative Within Roche’s Global QC Network
This article describes the numerous activities in the commercial quality control (QC) network that…
PE Articles
Plastic Process Waste in Biopharmaceutical Manufacturing
This article presents a comprehensive analysis of plastic waste generation in the biopharmaceutical…
iSpeak Blog
FDA on AI in Pharmaceutical Manufacturing
At the 2024 ISPE Biotechnology Conference, held in Boston, Massachusetts, USA, in June, Sharmista…
PE Articles
Gene Editing and Facility Retrofits for CRISPR and Beyond
With the approval of the first gene edited therapeutic in 2023, production of gene edited therapies…
iSpeak Blog
When Analytics Meet Quality
Intersection of Analytical Techniques and Quality Management In today’s data-driven world, the…
iSpeak Blog
Where Are We on the Digital Road Map? Find Out at the 2025 ISPE Biotechnology Conference
Digital transformation isn’t a future concept in the biopharmaceutical industry—it is already…
iSpeak Blog
Shaping the Future of Biomanufacturing Facilities
Biomanufacturing is advancing rapidly, and as the industry evolves, so too must the facilities that…
Video
Baseline Guide Vol 6: Biopharmaceutical Manufacturing Facilities 3rd Edition
This third edition of the ISPE Baseline® Guide: Biopharmaceutical Manufacturing Facilities intends…
iSpeak Blog
Biotech Sessions at the 2025 ISPE Europe Annual Conference Highlight ATMPs including Large Molecules and Cell and Gene Therapies
The biotech sector, which includes advanced therapy medicinal products (ATMPs) including large…
PE Articles
The Role of AI and ML in Efficiency and Innovation
The integration of artificial intelligence (AI) and machine learning (ML) into bioprocess…
PE Articles
Artificial Intelligence in Drug Target Discovery
The intersection of AI and drug development has ushered in a transformative era, revolutionizing the…
PE Articles
Single-Use Technology Waste in Manufacturing Operations
Single-use products used in the production of biologics provide flexibility that was unimaginable a…
PE Articles
3R Initiative Within Roche’s Global QC Network
This article describes the numerous activities in the commercial quality control (QC) network that…
PE Articles
Plastic Process Waste in Biopharmaceutical Manufacturing
This article presents a comprehensive analysis of plastic waste generation in the biopharmaceutical…
iSpeak Blog
FDA on AI in Pharmaceutical Manufacturing
At the 2024 ISPE Biotechnology Conference, held in Boston, Massachusetts, USA, in June, Sharmista…
PE Articles
Gene Editing and Facility Retrofits for CRISPR and Beyond
With the approval of the first gene edited therapeutic in 2023, production of gene edited therapies…
iSpeak Blog
When Analytics Meet Quality
Intersection of Analytical Techniques and Quality Management In today’s data-driven world, the…
iSpeak Blog
Where Are We on the Digital Road Map? Find Out at the 2025 ISPE Biotechnology Conference
Digital transformation isn’t a future concept in the biopharmaceutical industry—it is already…
iSpeak Blog
Shaping the Future of Biomanufacturing Facilities
Biomanufacturing is advancing rapidly, and as the industry evolves, so too must the facilities that…
Video
Baseline Guide Vol 6: Biopharmaceutical Manufacturing Facilities 3rd Edition
This third edition of the ISPE Baseline® Guide: Biopharmaceutical Manufacturing Facilities intends…
iSpeak Blog
Biotech Sessions at the 2025 ISPE Europe Annual Conference Highlight ATMPs including Large Molecules and Cell and Gene Therapies
The biotech sector, which includes advanced therapy medicinal products (ATMPs) including large…
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2024 ISPE Biotechnology Conference Q&A
The 2024 ISPE Biotechnology Conference will be held 17–18 June in Boston, Massachusetts, and…
New Guides Expand ATMP Knowledge
The ISPE Guide: Advanced Therapy Medicinal Products – Allogeneic Cell Therapy and the ISPE Guide…
Volunteer Leader Profile: Biotechnology CoP Co-Chair Laura-Ann Chin, PE
Laura-Ann Chin has more than 12 years of international and domestic contract and hands-on process…
Quality Risk Management for Biopharmaceuticals
In the dynamic and highly regulated world of biopharmaceutical manufacturing, maintaining and…
Cell Culture Media Manufacturing Controls for Bio-Manufacturing
Advanced therapy medicinal products (ATMPs) and cell and gene therapies (C>s) represent a…
The Role of AI and ML in Efficiency and Innovation
The integration of artificial intelligence (AI) and machine learning (ML) into bioprocess…
Artificial Intelligence in Drug Target Discovery
The intersection of AI and drug development has ushered in a transformative era, revolutionizing the…
Single-Use Technology Waste in Manufacturing Operations
Single-use products used in the production of biologics provide flexibility that was unimaginable a…
3R Initiative Within Roche’s Global QC Network
This article describes the numerous activities in the commercial quality control (QC) network that…
Plastic Process Waste in Biopharmaceutical Manufacturing
This article presents a comprehensive analysis of plastic waste generation in the biopharmaceutical…
Gene Editing and Facility Retrofits for CRISPR and Beyond
With the approval of the first gene edited therapeutic in 2023, production of gene edited therapies…
Repurposing a US Cell Therapy Facility for Flexibility and EU Compliance
The explosive growth of advanced therapy medicinal products (ATMPs), particularly cellular…
2024 ISPE Biotechnology Conference Q&A
The 2024 ISPE Biotechnology Conference will be held 17–18 June in Boston, Massachusetts, and…
New Guides Expand ATMP Knowledge
The ISPE Guide: Advanced Therapy Medicinal Products – Allogeneic Cell Therapy and the ISPE Guide…
Volunteer Leader Profile: Biotechnology CoP Co-Chair Laura-Ann Chin, PE
Laura-Ann Chin has more than 12 years of international and domestic contract and hands-on process…
Quality Risk Management for Biopharmaceuticals
In the dynamic and highly regulated world of biopharmaceutical manufacturing, maintaining and…
Cell Culture Media Manufacturing Controls for Bio-Manufacturing
Advanced therapy medicinal products (ATMPs) and cell and gene therapies (C>s) represent a…
The Role of AI and ML in Efficiency and Innovation
The integration of artificial intelligence (AI) and machine learning (ML) into bioprocess…
Artificial Intelligence in Drug Target Discovery
The intersection of AI and drug development has ushered in a transformative era, revolutionizing the…
Single-Use Technology Waste in Manufacturing Operations
Single-use products used in the production of biologics provide flexibility that was unimaginable a…
3R Initiative Within Roche’s Global QC Network
This article describes the numerous activities in the commercial quality control (QC) network that…
Plastic Process Waste in Biopharmaceutical Manufacturing
This article presents a comprehensive analysis of plastic waste generation in the biopharmaceutical…
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July / August 2024
The explosive growth of advanced therapy medicinal products (ATMPs), particularly cellular…
May / June 2024
The commercialization of personalized medicine has ushered in demand for a new type of facility—…
November / December 2023
There is much that large-scale commercial stem cell therapy processes can adopt from the existing…
May / June 2022
Realizing the promise of any novel viral vector therapeutic depends on the innovator’s ability to…
