Newsletter | February 19, 2025

02.19.25 -- A Look At Pharmaceutical Inspection Machine Advanced Technologies

SPONSOR

Unlock the future of advanced therapy medicinal products and antibody-drug conjugates using advanced analytics at the 2025 ISPE Aseptic Conference, taking place March 17-18 in Washington D.C., United States and virtually. Breakout sessions and panel discussions will focus on the following tracks: Advanced Modalities; Advanced Therapy Medicinal Products (ATMPs); Case Studies; Filling Operations; Regulations and Pharma 4.0™; Sterility and Release. Learn more and register.

FOCUS ON FILL-FINISH

A Look At Pharmaceutical Inspection Machine Advanced Technologies

Pharma and biotech companies are increasingly using inspection machines with advanced technologies, such as x-ray inspection, robotics, and more, to help them get ahead of the competition.

How Recent Trends Impact Bringing Your Molecule To Market

With accelerated approval times, growing competition between drugs, and a shift from hospital to home care, you’re under pressure to develop a delivery device in parallel with your drug.

Enhancing Patient Adherence Through Autoinjector Access

As autoinjectors evolve to accommodate a diverse array of chronic diseases, consider the impact of partnering with experienced device manufacturers and fill/finish providers.

Is Your Biologic At Risk For Protein Aggregation? Part 1

This is the first installment in a three-part series that examines the causes of protein aggregation and practical steps you can take to mitigate the risk.

FILL-FINISH SOLUTIONS

Validation Of Aseptic Fill/Finish And Related Processes - Mesa Laboratories

Secure Connections In Cryogenic Applications - Nordson MEDICAL

FOCUS ON DOWNSTREAM MANUFACTURING

mRNA Product Purification Process Strategies

Impurities from IVT can induce undesired immune responses and negatively impact translation efficiency. Explore the pros and cons of each option for mRNA purification.

Solving Cost And Supply Challenges In Biopharma Downstream Processing

In response to the growing demand for monoclonal antibodies, researchers are looking at different areas of the downstream process where they can improve efficiency and scalability.

Getting More From Your Buffer Management Strategy

A drug manufacturer faced challenges in buffer management. By implementing innovative inline buffer formulation technology, they were able to save space, increase efficiency, and become more sustainable.

Optimize And Monitor AAV Capsid Purification Using Mass Photometry

Study the performance of a mass photometer that was used to analyze AAV samples at various stages of purification to confirm column binding, and to monitor elution from the chromatography column.

Immunoassays And Orthogonal Characterization

Learn about host cell proteins (HCPs) along with how they are produced, their negative effects, how to identify HCPs in drug substances, and some technologies offering a solution for manufacturers.

Demystifying Lyophilization: Understanding The Freeze-Drying Process

Advancements in lyophilization technology and research have helped overcome inherent challenges and ensure the safety and efficacy of lyophilized pharmaceuticals.

DOWNSTREAM MANUFACTURING SOLUTIONS

An Automated Single-Use Filtration System For Crossflow Filtration - Cytiva

Protein Capture Devices For Antibody Purification - W.L. Gore & Associates

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