Newsletter | January 13, 2021

01.13.21 -- Managing Quality, cGMP Compliance Capability Of CMOs

 
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Analytical Instrumentation: Advancing A CDMO’s Capabilities

To serve client needs as pharma tech advances, a CDMO must know when to acquire new tech, increase overall instrument capacity, and maintain existing validated instrumentation.

Flow Chemistry: Scale-Up Solution For Modern API Manufacturing

Once deemed an experts-only approach to chemical synthesis, flow chemistry is a cost-efficient technique growing in popularity that can increase safety and flexibility and improve product quality.

Business Continuity Program: Maintain Operations During Crises

Get insights into implementing a robust business continuity management program that can help secure supply, reduce risks, and maintain quality in manufacturing operations through a crisis situation.

Ensuring Consistency In The Supply Of Cell Culture Media

This paper describes a robust global manufacturing network for cell culture media that supports capacity expansion to meet growing demand and ensure business continuity.

Implementation Of Single-Use In Drug Substance Filling Before Transportation

The development of a new product or service is better done as a collaboration between the developer and the potential end user(s).

Case Study For Developability Assessment Of Three Therapeutic Antibodies

This poster reviews studies for three monoclonal antibody (mAb) drug candidates utilizing a panel of small-scale, fast, and predictive tests used to evaluate therapeutic antibodies’ developability.

Rapid Transfer Of Raman Spectroscopy Models: Process Development To Manufacturing

This poster describes the rapid transfer of Raman spectroscopy models from process development (PD) to commercial manufacturing scale, including results of process scalability tests and successful model transfer.

Corynex Protein Expression: Simplifying Recombinant Protein Production

Adding biologics to your pipeline requires innovative approaches to drug development and cost mitigation. Simplifying the recombinant protein production and purification processes is a good place to start.

Getting Your Investigational Drug Regulatory Ready

Here, we map out basic information to help you approach regulatory policies and offer helpful strategies to facilitate efficient regulatory review and drug approval.

Clarifying And Sterile Filtering Cells For Protein Purification Workflows

Centrifugation and filtration have been widely accepted as techniques required for clarifying complex cell cultures to recover extracellular proteins such as monoclonal antibodies (mAbs). This scientific brief offers an alternative.

Bioprocess Media Pooling Case Study

How a sterile, closed system created process efficiency by removing the need for a biosafety cabinet and enabling the manipulation of presterilized assemblies in a more comfortable, ergonomic setting.

Softgel Technologies Overview

Innovative softgel technologies that maximize your market potential: where ideation and expertise come together.

Biologics Drug Product: Formulation, Tech Transfer, Delivery Strategies

This webinar covers the key considerations for formulation screening of therapeutic proteins with a focus on maintaining protein stability and avoiding aggregation.

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