Newsletter | June 9, 2021

06.09.21 -- Cell & Gene Therapy Bioprocessing: Control, Expertise, & CMO Demand

Featured Editorial
Industry Insights
How Can Extrusion Benefit Your Pharmaceutical Oral Drug Product?

Due to its immense adaptability, extrusion has been widely utilized in diverse fields. More recently, it is being adopted by the pharmaceutical industry at an unprecedented pace.

Align Your Chemistry, Manufacturing, And Controls (CMC) Strategy With Clinical Path Requirements And Timeline

Manufacturers must understand the challenges associated with creating a chemistry, manufacturing, and controls (CMC) strategy in today’s crowded and diverse market and the expertise and resources needed to successfully execute it.

Establishing A Remote Audit Process As A CDMO

Compliance audits are not immune to the effects of the pandemic. We have been required to adapt quickly to the changing environment to maintain high service levels while protecting employee and client safety.

Low-Risk Process Transfer From Development To Manufacturing

This article explores one approach for overcoming several scale-up issues with the use of miniature bioreactors for process development.

Growing With A Flexible, Collaborative CDMO

Choosing a CDMO that is agile, innovative, and exhibits a willingness to invest in new equipment, infrastructure, and services will allow the innovator company and the CDMO to grow together.

Sponsor Challenges When Outsourcing Sterile Injectables

ISR asked outsourcers of sterile injectable drug product to identify their biggest challenge when outsourcing to CDMOs/CMOs. Here's a look at the resulting nearly four-way tie.

Minimizing On-Column Monoclonal Antibody (mAb) Aggregate Formation

The formation of undesirable aggregates is a common occurrence during monoclonal antibody (mAb) purification and can result in altered pharmacodynamics, pharmacokinetics, and/or increased immunogenicity.

Reducing Chemistry, Manufacturing, And Controls (CMC) Risk In Cell And Gene Therapies, From IND To Commercial

Experts in the cell and gene therapy field share their experiences and discuss emerging trends to accelerate lifesaving therapies from the bench to the bedside.

8 Misconceptions About Embedded CDMOs

Access to the expert capabilities of embedded CDMOs is offering great economies and competitive experience to the sector.

Spray-Dry Manufacturing Formulations For Local Lung Cancer Treatment
Recent advances in spray-drying technology show promising results and potentially facilitate more effective monoclonal antibodies (mAbs) through direct delivery to the lung.
Strategies For Mitigating Supply Chain Risk In Clinical Trials

This article is a guide through numerous considerations to decide whether to build your capability, outsource it, or create a hybrid insource/outsource model.

Six Strategies To Improve Your Approach To Fill/Finish Manufacturing

Demand to increase speed and flexibility while maintaining sterility spurs the adoption of novel technologies and materials, all of which introduce new challenges.

Advance Your Western Workflow Into The 21st Century With Abby

Protein analysis comes with many challenges, typically requiring labor-intensive, time-consuming protocols such as the Western blot, which has multiple hands-on steps that increase user error and data variability. 

From Molecule To Medicine. Delivered.

To be able to meet the growing needs of patients around the world, a company must have a strategy that can shepherd new biologics therapies throughout the development timeline.


Date: Tuesday, June 29, 2021
Time: 11:00 a.m. Eastern Daylight Time
Duration: 1 hour

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