Newsletter | August 27, 2025

08.27.25 -- Addressing Manufacturability And Scalability Challenges In Multispecifics Purification

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Pure Performance, Trusted Storage

From bottles to high-capacity carboys, Nalgene™ containers deliver sterile, leakproof protection for pH-sensitive, frozen, and harsh bioprocess materials. Select from our standard bottle and carboy options, or choose from our Certified Clean (low particulates) or Platinum Certified Clean (ultra-low particulates) level containers. Available in a wide range of resins including PC, PETG, HDPE, and more—in volumes ranging from 5 mL to 50 L to fit your workflow. Explore Nalgene™ Containers.

FOCUS ON DOWNSTREAM MANUFACTURING

Manufacturability And Scalability Challenges In Multispecifics Purification

In this segment from the Bioprocess Online Live event, “Challenges And Considerations For Purifying Multispecific Molecules,” our panelists answer some remaining audience questions relating to viral inactivation, affinity resins, precipitation steps in purification, and downstream scalability challenges.

mRNA Process And Cost Modeling: A Tool To Optimize Process Development

Demand for mRNA-based medicine production continues to increase, as do investments in prophylactic and therapeutic indications. Explore a cost-model that compares all modalities.

Eliminate Downstream Bottlenecks In Antibody-Based Therapies

Organizations seeking greater efficiency within their downstream purification processes are well-served in considering a single-use, membrane-based solution in lieu of resin-based purification columns.

Top Five Downstream Processing Challenges For Viral Vectors And 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.

Utilizing Small-Scale Downstream Studies Across Biologics Manufacturing

Small-scale downstream studies play a critical role in enabling efficient, low-risk tech transfer for biologics development.

Predicting Viral Clearance Through CHO-RVLP And MVM-Mock Viral Particles

Reduce the cost and complexity of viral clearance validation with non-infectious surrogates. Learn how CHO-RVLP and MVM-MVP enable safer, more efficient biopharmaceutical process development.

Safer AAV Through Reduced Host-Cell DNA Encapsidation

While most hcDNA molecules outside AAV particles can be eliminated during downstream processing, encapsidated hcDNA molecules remain largely undetectable. Learn how to overcome this critical issue.

Manufacturing ADCs: Extractables In Single-Use Systems

Antibody-drug conjugates offer targeted cancer treatment with reduced toxicity. Discover how single-use technologies simplify ADC manufacturing to ensure safety, flexibility, and efficiency.

Advanced Purification To Improve Manufacturing Efficiencies

Discover how advanced resin technology improves biopharmaceutical purification. Learn about enhanced performance, extended resin life, and reduced manufacturing costs.

DOWNSTREAM MANUFACTURING SOLUTIONS

Downstream Process Development Support And Services - Bio-Rad Laboratories, Inc.

Pharma+ Tubing Retainers - Nordson MEDICAL

Recombinant Protein Process Development And Scale-Up - Cytiva

FOCUS ON FILL-FINISH

Structural Characterization Of GLP-1 Analogues And Formulations Using MMS

Discover how MMS quantifies peptide concentrations and identifies structural differences in GLP-1 and its commercial analogues across various buffer systems.

Connection Technologies Enable Modular Single-Use Systems

Single-use systems are increasingly prevalent in biotechnology processes. Explore the benefits, challenges, and solutions presented by modular single-use systems.

Supporting The Unique Needs Of Your Sterile Injectable

Leveraging the experience and specialized technology of a reliable CDMO partner is essential to ensure your sterile injectable therapeutic's safety and quality while delivering at speed.

FILL-FINISH SOLUTIONS

Capacity Update April 2025: Fill/Finish - Argonaut Manufacturing Services

Proven Vial Containment That Scales From R&D To Commercial - West Pharmaceutical Services, Inc.

Environmental Monitoring For Aseptic Filling - Cytiva

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