Newsletter | November 24, 2021

11.24.21 -- Calculating The Process Capabilities Of Cleaning Processes: A Primer

 
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Industry Insights
Embedded CMO: From Development Through Commercialization

The right CMO can expedite market launch, and an embedded CMO offers many advantages over other CMO models, including access to the extensive capabilities and knowhow of the parent organization.

How A Small Biotech Advanced Its Complex Bispecific Antibodies

Surrozen’s president and CEO, Craig Parker, discusses the expertise, resources, and flexibility that advanced its novel and complex bispecific antibody candidates targeting the WNT pathway.

Steps To Consider For Implementing Continuous Bioprocessing

Though process intensification has obvious efficiency improvement benefits, it can be challenging to implement. What steps should companies take as they move toward more modern operations?

Simplifying The Bioprocessing 4.0 Journey

With a practical stepwise approach starting with process analytical technology (PAT), plug and play/industry-standard interfaces, data analytics, and improved controls for certificate of pharmaceutical product (CPP) monitoring, Bioprocessing 4.0 is achievable.

Shaping Biopharma's Future: Next-Gen Contract Drug Manufacturing

With the biopharmaceutical industry undergoing significant transformation, it is essential that CDMOs evolve to meet the intricate, dynamic needs of their clients.

Utilizing Single-Use Powder Handling To Reduce Contamination

Read how upgrading to modern single-use powder handling gets a product to market without time wasted on complicated weigh and dispense steps, cleaning validations, or powder in the air and in the suite.

Simplifying Adeno-Associated Virus (AAV) Protein Analytics

This poster demonstrates how we used a single Maurice platform to analyze adeno-associated viruses (AAVs) by icIEF and CE-SDS methods to ensure product stability, identity, and purity.

Vericheck ddPCR Mycoplasma Detection Kit

This probe-based sensitive and specific kit has been designed and validated to meet European, U.S., and Japanese pharmacopoeia requirements and can detect up to 122 Mycoplasma species.

Bringing Lab Automation Into The Mainstream

What are the driving factors that are required to make process and system automation commonplace in the pharma and biotech R&D sector?

Manufacturing Strategies To Industrialize Autologous Cell Therapies

While the first autologous cell therapy commercial products have shown tremendous clinical success, scaling out these therapies while considering individual patient processes is a new challenge.

In-Line Monitoring During Downstream Purification

Here we explore a solution that offers in-line real-time monitoring across biopharmaceutical unit operations with little training, machinery, or human intervention.

Robust, Load-Independent Viral Clearance In Monoclonal Antibody (mAb) Purification

How the Natrix Q chromatography membrane overcame diffusion and binding capacity limitations and improved cost-efficiency in a study measuring the removal of four model viruses.

Moving Forward With The Next Generation Of Buffer Prep Solutions

How next-gen buffer prep solutions leverage automation and remote operation while reducing the overall footprint, labor, and cost associated with more traditional approaches.

Material Characterization For Adeno-Associated Virus (AAV) Process Development, Tool Selection

Entegris' Joy Xiaohui Chen and Cari Sadowski of Fujifilm Diosynth Biotechnologies evaluate single-use bag material interaction and the adsorptive relationship with AAV viral vectors during storage.

Essential Up-Front Planning For Your Clinical Trial

Early planning mitigates risk by avoiding stock outs and study delays, minimizing waste with optimized inventory and forecasting demand to facilitate robust supply planning.

Host Cell Protein (HCP) Analysis, Orthogonal Methods In Vaccine, Gene Therapy Development

A discussion on orthogonal antibody affinity extraction (AAE) and mass spectrometry methods used to assess ELISA Ab coverage to HCPs present in a process and identifying process-specific HCPs that may co-purify with a drug substance.

Vero Cell Cultivation For Vaccine Production

How process parameters can be monitored and controlled in a perfusion process to cultivate anchorage-dependent cells using packed-bed bioreactors or microcarrier spin filters in cell-based vaccine production.

Process Impurities: Don’t Let Polyethylenimine (PEI) Or Host Cell Proteins (HCPs) Derail Your Biotherapy

Learn product characterization strategies to de-risk manufacturing and detect and characterize host cell proteins (HCPs) and polyethylenimine (PEI) in monoclonal antibody (mAb) and cell and gene therapies.

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