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
2024 ISPE Biotechnology Conference Q&A
The 2024 ISPE Biotechnology Conference will be held 17–18 June in Boston, Massachusetts, and…
PE Articles
New Guides Expand ATMP Knowledge
The ISPE Guide: Advanced Therapy Medicinal Products – Allogeneic Cell Therapy and the ISPE Guide…
PE Articles
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…
Video
Unique Aspects of OOS Investigations Related to Biotech Products
Unique Aspects of OOS Investigations Related to Biotech Products Complimentary Learning Level…
iSpeak Blog
Data Science-Assisted Biopharmaceutical Tech Transfer and Process Characterization
The integration of data science in biopharmaceutical manufacturing, emphasizing data quality, tech…
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…
PE Articles
Repurposing a US Cell Therapy Facility for Flexibility and EU Compliance
The explosive growth of advanced therapy medicinal products (ATMPs), particularly cellular…
PE Articles
Bio-Fluorescent Particle Counter (BFPC) Continuous Environmental Viable Particle Monitoring Strategy for Aseptic Filling
The adoption of Environmental Monitoring (EM) through modern technologies, such as BFPCs, has proven…
PE Articles
A Simplified Integration of Qualified Laboratory Devices with the Asset Administration Shell as the Digital Twin
This Concept Paper proves a laboratory device integration utilizing the Asset Administration Shell…
Video
Attend the 2024 ISPE Biotechnology Conference
The 2024 ISPE Biotechnology Conference will bring together leading pharmaceutical and…
iSpeak Blog
Trends and Innovations in Bio-Manufacturing. Global Outlook on the Future of Biopharmaceuticals.
The outlook for the biopharmaceutical market is promising, with expectations that the market will…
PE Articles
2024 ISPE Biotechnology Conference Q&A
The 2024 ISPE Biotechnology Conference will be held 17–18 June in Boston, Massachusetts, and…
PE Articles
New Guides Expand ATMP Knowledge
The ISPE Guide: Advanced Therapy Medicinal Products – Allogeneic Cell Therapy and the ISPE Guide…
PE Articles
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…
Video
Unique Aspects of OOS Investigations Related to Biotech Products
Unique Aspects of OOS Investigations Related to Biotech Products Complimentary Learning Level…
iSpeak Blog
Data Science-Assisted Biopharmaceutical Tech Transfer and Process Characterization
The integration of data science in biopharmaceutical manufacturing, emphasizing data quality, tech…
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…
PE Articles
Repurposing a US Cell Therapy Facility for Flexibility and EU Compliance
The explosive growth of advanced therapy medicinal products (ATMPs), particularly cellular…
PE Articles
Bio-Fluorescent Particle Counter (BFPC) Continuous Environmental Viable Particle Monitoring Strategy for Aseptic Filling
The adoption of Environmental Monitoring (EM) through modern technologies, such as BFPCs, has proven…
PE Articles
A Simplified Integration of Qualified Laboratory Devices with the Asset Administration Shell as the Digital Twin
This Concept Paper proves a laboratory device integration utilizing the Asset Administration Shell…
Guidance Documents
Advanced Manufacturing (2)
+Advanced Therapy Medicinal Products (1)
+Biotechnology (6)
+Containment (1)
+Investigational Products (1)
+Lifecycle Management (2)
+Manufacturing Operations (3)
+Quality by Design (1)
+Community Discussions
Community Discussions
Dec 16, 2024
Biotechnology
Containment
Dec 02, 2024
Biotechnology
Pharmaceutical Engineering Magazine Articles
Building Better Therapies With Antibody Engineering
Antibody engineering has transformed the development of therapeutic antibodies, enabling the…
Post-Approval Change Management for Cell and Gene Therapy Products
Cell and gene therapy (C>) products represent a significant step forward in patient treatment and…
Using Industry Survey Data to Shape Cell Therapy Facility Design
Cell therapies have been used to treat thousands of patients worldwide ever since the CAR T cell…
2023 ISPE Biotechnology Conference: Keynote Presentations
The 2023 ISPE Biotechnology Conference opened on 26 June with a series of six keynote presentations…
Live Biotherapeutic Products: Moving the Microbiome to the Patient
Live biotherapeutic products (LBPs) have the potential to treat a wide range of ailments. However…
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…
Building Better Therapies With Antibody Engineering
Antibody engineering has transformed the development of therapeutic antibodies, enabling the…
Post-Approval Change Management for Cell and Gene Therapy Products
Cell and gene therapy (C>) products represent a significant step forward in patient treatment and…
Using Industry Survey Data to Shape Cell Therapy Facility Design
Cell therapies have been used to treat thousands of patients worldwide ever since the CAR T cell…
2023 ISPE Biotechnology Conference: Keynote Presentations
The 2023 ISPE Biotechnology Conference opened on 26 June with a series of six keynote presentations…
Live Biotherapeutic Products: Moving the Microbiome to the Patient
Live biotherapeutic products (LBPs) have the potential to treat a wide range of ailments. However…
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…
Webinars
Upcoming
On-Demand
White Papers
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…
Lifecycle Approach to Biotech Process Validation
This discussion paper proposes ideas for answering the questions about the application of the…
