New analysis methods are needed for sub-visible particles in drug development

At Vironova we’re in the business of electron microscopy-based digital image analysis of sub-visible particles to provide objective and meaningful information during process development and quality control of vaccines and drug/gene delivery systems.

In current advances in drug-delivery, production of vaccines and drug formulation there are many applications for nano-sized particles such as liposomes and virus particles, and these constitute fast growing and promising technologies for new treatment development.

There are strict requirements for monitoring of processes and quality control within the pharmaceutical sector and Vironova is unrivalled in providing a comprehensive solution of analytical products and services tailored to this highly regulated environment.

Continue reading “New analysis methods are needed for sub-visible particles in drug development”

Evolution of the Vaccine Industry

At BioProcess International 2015 we caught up with Rahul Singhvi, Chief Operating Officer at Takeda Vaccines, who told us about the general evolution of the vaccine industry over the years and what it looks like today.

Singhvi describes how companies in the vaccine space today tend to be very insular, controlling all aspects of the process, but that Takeda is taking a partnering approach, which he sees as very important.

Singhvi goes on to discuss what he feels the greatest needs and opportunities are in terms of technological innovation, development and manufacturing solutions, before making some bold predictions about the future of the vaccine industry, and the key trends and opportunities to watch out for.

3 Biologics Industry Predictions from 2015 vs the 2016 Reality

For an industry as fast-moving as the biopharmaceutical industry, it is always interesting to look back at past predictions and to compare them to where we currently find ourselves. Last year we sat down with Günter Jagschies, a Senior Director at GE Healthcare Life Sciences, to discuss the trends in different sectors of biopharma. Here we look though Jagschies’ predictions from 2015 and compare them to state of the industry today.

Continue reading “3 Biologics Industry Predictions from 2015 vs the 2016 Reality”

The Value of Small Scale Studies

mic image

BioProduction recently caught up with Brij Patel, Deputy Manager and Assessor, MHRA to find out more about his upcoming talk at this year’s event and what attendees can take away from his session

BioProduction (BP): Could you give us a brief overview of your key research interestes?

Brij Patel (Brij): Originally, my research experience stems from work with vaccines and drug delivery technology. I still remain interested in vaccines and biotech products, but now from a regulatory perspective (where I have had considerable experience as a regulatory evaluator for biological products on both MHRA and EMA applications).

BP: What can industry gain from this?

Brij: The ultimate aim is to attain regulatory approval – as fast and as efficiently as possible. My previous regulatory experience would provide an insight into how regulators assess risks and solutions.

BP: And what work will you be presenting at BioProduction this year?

Brij: EU regulators have now come across a number of QbD applications for biological products. There is obviously a “disconnect” between industry and regulators. I would like to present a reflection on regulatory experience with biological QbD

BP: What will our delegates gain by attending your presentation and session? What is the message you would like them to leave with?

Brij: Some of the key issues include agreement on risk assessments, the value of small scale studies, and regulatory flexibility. Communication (appropriate detail, at the right times, FTF meetings) is critical in order to persuade the regulator when deviating from the usual

BP: How will the industry look in 2-3 years? What challenges will still remain/would have been overcome?

Brij: QbD principles will be built into most programmes. The issue will be how to get ROI

BP: What did you want to be when you were young?

Brij: Useful

For more information about Brij’s talk and all of our other presentations, please visit our website or download the brochure