Newsletter | November 29, 2023

11.29.23 -- Vaccine Maker's Toolkit: Strategies For Manufacturing And Supply Management

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Improving Resilience Of Post-Pandemic Biopharma Supply Chains

Improving supply chain resilience is critical for biopharma. One lesson learned from the pandemic is the need for new models and approaches to managing supply chains. Download our white paper to learn more about how a value chain model mitigates risk, the four critical ingredients to supply chain resilience, and why preparations based on "the last war" aren’t enough.

FEATURED EDITORIAL

Vaccine Maker's Toolkit: Strategies For Manufacturing And Supply Management

This collection of insights highlights strategies and guidance to ensure reliable biomanufacturing capacity and supply chains for the delivery of health technologies, even during crisis conditions.

Illuminating The Innovation Behind A New Era Of Cancer Vaccines

As the immunology space expands to make vaccines a viable cancer treatment option, developers are coming up with creative solutions to reach FDA approval and maximum efficacy for patients.

INDUSTRY INSIGHTS

Unlock Potential In Buffer Preparation

Compare in-house buffer preparation to outsourcing buffer preparation activities, highlighting the potential for optimizing resources and mitigating risks.

Ensuring Biomanufacturing Resilience For Biologics And Vaccines

Learn about different strategies for ensuring the reliable delivery of health technologies with a focus on vaccines, mAbs, and new modalities manufactured by biotechnology companies and institutes.

Overcoming Manufacturing Challenges For Advanced Medicines

Watch as biopharmaceutical experts discuss the various obstacles teams face when leading the operations and manufacturing of advanced medicines and the strategies to overcome them.

To GMP Or Not To GMP? That Is The (Plasmid) Question

As critical raw materials for viral vector production, plasmids are in high demand. Finding an experienced, GMP-grade plasmid supplier for your process can mitigate risk and yield reliable results.

Build vs. Outsource For Drug Development And Manufacturing

The decision whether to develop and manufacture a drug in-house or to outsource comprises numerous elements, including costs, timelines, production capacity, and available resources.

Bridging Anti-E. Coli HCP Antibodies And E. Coli Antigens

Read this expert comparative coverage analysis study performed to assess the reactivity of anti-E. coli HCP antibodies that support ELISA kits.

CRISPR/Cas Nucleases Product Guide

Discover how manufacturing research-grade Cas enzymes in an ISO 13485 certified facility enables a seamless transition to a cGMP product as you progress into the clinic.

Quantifying Latency In Batch Processing

In batch processing operations, the combination of numerous concurrent and independent steps can lead to bottlenecks. Learn how to find the root cause and solution for every operational delay.

Meeting The Changing Demands For Sterile Fill/Finish Operations

Meeting the growing demand for aseptic fill/finish operations requires specialized expertise, appropriate equipment, and innovations in both emerging technology and business models.

U.K. Regs: Post-Brexit Qualified Person Requirements

Explore key advice for fulfilling qualified person requirements and minimizing supply chain risk and clinical trial disruption under the new rules of the U.K.’s Trade and Cooperation Agreement with the EU.

Biopharma Tech Transfer: Facility Fit And Process Gap Assessments

Biopharmaceutical tech transfer, critical to the successful development and manufacture of an asset, requires careful planning and evaluation to meet project timelines for scale-up and GMP.

Manufacturing Cytotoxic And Non-Cytotoxic Drugs In A Multiproduct Facility

The experience and expertise of the CMO is crucial to avoid the risk of cross-contamination of the drug product, as failures or weaknesses in this process can pose risk to the end user.

Magnetic Bead Removal Using Microcarrier And Cell Separation System

The FDA holds strict requirements for magnetic bead removal prior to therapeutic use. Learn how this system effectively separates cells from microcarriers and provides maximum cell recovery.

Advancements In Antibody Purification

Learn about emerging technologies and approaches for intensifying mAb purification and diversifying bispecific antibody, fragment, and ADC pipelines.

Achieve Fast And Efficient Isolation Of Exosomes From Stem Cells

Review the demonstration of how a bioreactor and bioreactor system combination was used to isolate exosomes after culturing human adipose-derived stem cells in suspension on microcarriers.

Accurate HC-LC Pairing And A Close-To-Nature Solution For bsAbs

Examine how a proprietary technology ensures high levels of accurate HC-LC pairing without detriment to critical quality attributes such as titer, binding affinity, stability, and immunogenicity.

Considerations For Migrating From Vial To Prefilled Syringe

Explore some of the most relevant engineering activities that are necessary to successfully transfer a product from vial into a prefilled syringe presentation.

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