Newsletter | September 20, 2021

09.20.21 -- 4 Keys To FDA Breakthrough Therapy Designation

 
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Drug Development From The Patient’s Perspective

How is patient-centricity influencing the therapy development process today, and how will the industry adapt for further patient-centric improvement?

Establishing A Remote Audit Process As A CDMO

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

Seed Train Intensification Using High Cell Density Cryopreservation

High cell density cryopreservation and the use of a perfused seed train and specially designed expansion medium can create shorter lead times, reduce plant footprint, increase flexibility, and reduce cost of goods (COGs).

Virus Filtration Assurance Through Automation

Learn how to achieve virus filtration assurance with a purpose-built automation software that integrates our filtration expertise into your manufacturing suite at every step of the process.

Save Development Time, Economize Distribution With A Single Vendor

By minimizing the overall time, complexity, and effort of clients’ projects and reducing the risks, Thermo Fisher’s most complete integrated offering represents a strong single-vendor solution.

How To Prepare For Future Viral Vector Manufacturing

How to transition from what has historically been carried out in translational clinical centers at small scale using flasks and open systems, toward commercial production and methodologies.

Essentials Of Auditing In Cell And Gene Therapy Manufacturing

Read useful insights into auditing to help clients and contract manufacturing organizations (CMOs) understand this critical aspect.

Are You Prepared To Move A Bioconjugate From Clinic To Market?

Antibody-drug conjugates (ADCs) have become a groundbreaking tool in the industry’s fight against cancer, but, despite their potential, they present a wide range of challenges for drug manufacturers.

How To Choose A Sterile Connector

Without a reliable and robust connector, your batch could quickly be rendered worthless. Learn three considerations to give you confidence when selecting fluid handling connectors for your bio application.

Liposomal And Nanoparticle Technology At Pfizer Melbourne

In recent years, liposome technologies have become an important part of the drug delivery armory, with several marketed products now available and more formulations being evaluated in clinical trials.

Agile Process Development In Biopharmaceuticals

A lack of consistency in the capture, management, and analysis of data is a barrier to both collaboration and understanding and hampers the development of novel products and processes.

How To Accurately Weigh Portable Tanks

For a portable tank system to have high system accuracy, it must perform as well as stationary systems. There are several design variations with portable tank systems; this article will cover designs that work.

Novel Tool Box For Extracellular Vesicles (EVs) Therapy In Regenerative Medicine

Extracellular vesicles (EVs) derived from mesenchymal stem cells are a promising therapeutic strategy in regenerative medicine. This application note illustrates the use of our PS affinity EV isolation technology.

Bearing Failure Prediction

Bearings fail exponentially and with little notice, leading to expensive downtime. Preparing for and preventing bearing failure can reduce the costly and harmful effects of unplanned failures.

Zydis ODT Provides Better Treatments

Discover how Catalent's oral drug delivery offerings can help get your molecule to market faster. In this case study, learn the many benefits of our product offerings.

A Complete Guide To Aseptic Manufacturing

Aseptic manufacturing is a uniquely challenging process that requires expertise and careful planning. Gain insights and guidance on aseptic manufacturing, sterile fill/finish, and supporting activities.

Cell Culture Media Prototyping: Testing For Success

Screening pilot media can help you identify process and material optimizations that may provide benefits throughout your bioprocessing journey.

High-Containment Single-Use FIBC For Pharmaceutical Powder Handling

This webinar focuses on moving the highly potent API (HPAPI) powders through the entire process starting with chemical synthesis of the molecule to finishing in multiple solid dosage forms.

Make It Right: Best Practices For mRNA Manufacturing

This webinar explores key considerations for efficient mRNA production, starting from facility design and raw materials selection to technologies and strategies used for manufacturing.

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ISR Reports is a full-service market research company and sister company of BioProcess Online. Operating exclusively in the pharmaceutical and pharmaceutical services industry, their syndicated and custom market research capabilities enable their customers to make smarter, more informed business decisions.

 

Topics include: Manufacturing practices and models, trends and technology, commercialization, dosage forms, excipients, outsourcing strategies, and more.

 

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