Newsletter | September 21, 2021

09.21.21 -- How To Accelerate Viral Detection From Weeks To Days

Alternatives To In Vivo Assays For Biosafety Testing Of Biologics

A critical aspect of developing biologics-based medicinal products is biosafety evaluation of materials and intermediates used in manufacturing. Even as alternative methods such as PCR and NGS have emerged, in vivo tests have stubbornly remained a central part of testing. Here we examine current in vivo methods and explore modern alternatives.

Product Characterization: Reveal Your Molecule Earlier, Faster, And With Accuracy

Utilizing a CRO as a partner can help streamline your drug development program, mitigate risks, and help avoid common manufacturing pitfalls, ultimately moving your monoclonal antibody (mAb) from concept to clinic with efficiency and within tighter timelines. However, when selecting a partner for product characterization, one should look for more than just data.

How Biosafety Testing Will Evolve To Meet The Needs Of Biologics Manufacturers Tomorrow

The pressure to shorten delivery times and reduce costs for biologics such as monoclonal antibodies (mAbs) is driving an evolution in the biomanufacturing space. Ironically, where we see almost daily innovation in production technologies, many of the methods used for biosafety testing are decades old. In this talk we will explore how new methods can be used to accelerate biosafety testing today.

How Biosafety Assurance Can Be Both Rapid And Purposeful, Getting You To The Finish Line First

The advancement of bioprocessing and the rise of novel treatment modalities such as viral vectors, as well as the urgent need for COVID-19 treatments and vaccines, have driven the industry to adopt rapid alternatives. In this webinar, learn the reasons behind the move to faster methods and the wider benefits these can bring.

Blazar Platform: Rodent Virus Panel From The BioReliance Portfolio

The use of animal models in the safety testing of biopharmaceuticals has long been a regulatory requirement. However, there is an industry and regulatory imperative to reduce the use of animals in accordance with the 3Rs principles. The rodent virus panel outlined here provides a suitable alternative to the current in vivo mouse, hamster, and rat antibody production (MAP/HAP/RAP) test that eliminates the need for animals.