Newsletter | April 30, 2025

04.30.25 -- Do Patient Needs Define Biologic Product Specifications?

SPONSOR

Webinar: PUPSIT Without The Pain: Practical Solutions For Implementation

Join our webinar to explore the critical role of PUPSIT in quality risk management. We’ll cover key risks, including IT methods, wetting, dilution, and recovery, while offering practical solutions for single-use systems. Learn about new standard filtration systems and real-world implementation examples to streamline sterile drug product filtration. Click here to learn more.

FOCUS ON FILL-FINISH

Do Patient Needs Define Biologic Product Specifications?

Enhanced product understanding acknowledges the technology advancements of the last 25 years and substantially more complex drug modalities.

Managing Risks In Injectable Drug Delivery

Gain insights pertinent to efficient and effective drug development. Understand and execute a risked-based critical thinking approach related to injectable drug packaging and delivery.

FILL-FINISH SOLUTIONS

Aseptiquik W Series Connectors With 1½ Inch Flow Path - CPC

PharmaLok ZerO Sanitary Clamps - Nordson MEDICAL

SPONSOR

Multispecific molecules bring added complexity to downstream purification—think incorrect chain pairings, aggregation, fragmentation, and lower yields. Join Bioprocess Online Live as we explore how developers are addressing these challenges to achieve high purity and efficient processes. Gain insights into key considerations for downstream teams when designing purification strategies for these advanced biologics. Registration is free thanks to the support of Thermo Fisher Scientific.

FOCUS ON DOWNSTREAM MANUFACTURING

Downstream Processing's Top Five Challenges For Viral Vectors, Exosomes

From discovery to patient doses, viral vectors and exosomes face a complex journey. Researchers must navigate five key downstream processing challenges to ensure these therapies reach their full potential.

Virus Filtration: Regulations And Mechanisms

In this presentation, Dr. Nigel Jackson, Principal Engineer in R&D, offers an in-depth discussion on regulatory guidance and recent updates pertaining to virus filtration.

Leveraging Efficiency From CLD To Clinical Manufacturing Of mAbs

Discover how our efficient strategies can propel your mAb from discovery to clinical manufacturing in as little as 18 months.

Addressing Large Molecule Purification Challenges

Delve into innovative strategies to surmount purification challenges, including design of experiments (DOE) methodologies and insightful case studies centered around plasma protein and virus purification.

Enhancing The Patient Experience For Self-Injection Systems

Improving the experience for patients using self-injection systems is increasingly important. Practice devices help ease anxiety, build confidence, and ensure proper technique for prescribed treatments.

DOWNSTREAM MANUFACTURING SOLUTIONS

Sanitary Fittings: SF Series - Nordson MEDICAL

Buffer Innovation In A Single-Use Package - Asahi Kasei Bioprocess

Efficient And Scalable Preparative HPLC Solutions - Sartorius

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