Regulatory - Bioprocess Development Forum

Articles Regulatory

October 5, 2024

2024 Global Biopharma Sustainability Review

CytivaThis report is based on data from 800 pharma and biopharma professionals at director-level and…

Ross Burns

Articles Regulatory Upstream

September 6, 2024

Considering Process Scaling for Monoclonal Antibodies During Early Phase Development

Successful biomanufacturing processes not only provide the desired product in high yield and purity, they…

Ross Burns

Articles Regulatory

August 8, 2024

Address the complexity of protein characterization

Since the FDA approved the first monoclonal based therapy in 1985, mAbs have had significant…

Ross Burns

Articles Multimedia Regulatory Regulatory

June 13, 2024

Extractables in single-use systems used in ADC manufacturing, Part 2.

We performed extractables studies on single-use chromatography and tangential flow filtration systems using common solvents…

Ross Burns

Articles BioPharma Regulatory

April 5, 2024

Filtration methods to overcome new challenges in viral safety

Read our article which summarizes the recent virus filtration regulatory changes in PDA Technical...

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Articles Regulatory

February 9, 2024

Paring Down Impurities in Downstream Processing

Myriad choices confront manufacturers before they even consider optimizing downstream processes.

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Articles Regulatory

January 12, 2024

Dear lentivirus: We have not forgotten about you and how to improve your polishing recovery

Lentiviruses are commonly used for both chimeric antigen receptor (CAR) T cell therapy and ex...

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Articles Regulatory

December 1, 2023

Getting your investigational drug regulatory ready

Navigating regulatory requirements can be an overwhelming and time-consuming part of the translational...

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Articles Regulatory

August 25, 2023

A risk based approach to sterile filtration

Drug quality cannot be assured only by finished-product testing. Process validation is required to...

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Articles Regulatory

June 13, 2023

Simulation gets therapies to patients faster and smarter

Digital solutions are helping to decrease therapeutic time to market but remain challenging – learn…

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