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Cell Culture & Cell Therapy: Bioprocessing Conference

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Ask The Expert Questions

What do you think were the biggest factors that led to the anti-vaccine movement and what can we do to change public perception and assure safety.
Do you believe that vaccine manufacturing will eventually move to an entirely cell-based manufacturing? If so, what do you think will be the hurdles that must be overcome to make this happen?
What do you think the next big vaccine breakthrough will be?
Which vaccine, past or present, do you think has made the biggest impact on society?
We are working on a low cost device that is used with a syringe. Its use results in a substantial increase in the intradermal (ID) injection success while requiring minimal training in Mantoux technique. The current use of ID vaccination is limited to BCG and rabies and TB testing. Would you please suggest vacines in development that would likely benefit from a simple ID injection device.
Do you think polio will ever be eradicated?
Which up and coming vaccine technologies do you think show the most promise?
I am a concerned parent that lives in a school district where parents opting out of vaccination by using the religious exemption is about 6%. As a parent that vaccinates their child and sees the tremendous value of vaccines, I am concerned about children endangering my child because they are not vaccinated. Are my fears founded or does vaccinating my child protect them from these children that aren’t vaccinated.
I saw a clip on your new book and I was wondering in light of your new book. How would you recommend people research which if any vitamins are right for them?
What do you believe is the biggest obstacle faced in vaccine manufacturing today?
How can we eradicate the fugal contamination on our lab?
Is it possible the elimination of contaminated culture from bacterial, yeast, fungal etc.?
After thoroughly cleaning and sterilizing our lab after a bacterial contamination, we are worried about recontamination. Any thoughts about things we can do to ensure sterility after cleaning and any suggestions on how to test to be sure that the contamination is gone.
Recently we are facing a problem of culture getting white flocks in our culture. Even after adding more anti-micotic and anti-biotics to culture eradication is not possible. Fumigation has been done twice in two weeks but eradication seems impossible. Any help in this regard??
How can you ensure that your frozen cells, or cells you obtain through a collaboration aren’t contaminated?
Why is it so frowned upon to use antibiotics in cell culture now?
What are the important factors to consider when evaluating film for single-use applications?
What cell-line was used to evaluate cell culture performance with Bioclear™ 11 and how sensitive is it to the degradation product of TBPP?
Does the lower antioxidant level affect the shelf-life of Bioclear 11?
How has GE applied its expertise in film development?
What about leak resistance? As you have made changes to reduce leachables how has this impacted the strength of the bags?
Are bag decisions somewhat custom, I mean depending on the sensitivity of the cell line, drug product, etc. do you have recommendations about the make up of the bags that should be used?
How concerned are you about leachables/extractables in single use connectors and tubing? Do you have plans in these areas?
In your opinion when is the best time to evaluate extractables and leachables in your manufacturing process?
How do you match up the model solvents you use for testing with drug products?
Do you have recommendations for deciding how detailed the evaluation of extractables and leachables need to be? I know it is up to the company to decide but are there some guiding principals? Also, how is the work split between company and supplier when doing these evaluations. Is there some documentation that you will provide as part of the process?
In your opinion do you think that there is another bDtBPP type compound that we haven’t identified yet or do you think the key leachables have been identified and are being addressed.
Why doesn’t the industry move to standardized testing for single-use films and bags?
How does your film interact with lipids, is there a film recommendation related to lipids?
What film selection advice do you have for vaccine manufacturing and specifically virus production?
We are a company just starting to work on risk assessment for extractables and leachables after moving from stainless steel, what do you see are the biggest challenges? Any advice on avoiding potential pitfalls?
We are a lab scaling up from benchtop glass bioreactors to disposable bags, but are still working at fairly small scale. What kind of film questions should we be asking as we make the transition?
How has GE developed the capabilities to work with customers?
What type of enzymes will be detectable with these assays?
Is using your kits easier than preparing homebrew ELISA assays?
What are the sensitivity and measuring ranges of your assays?
What is the time to results for these assays?
What if you are not using Roche enzymes, can you still use these kits?
We are interested in conducting in process testing for residual enzymes to check our process efficiency at a couple stages. Can you explain what kind of information we will gain by running your kits particularly with respect to in process tests? Also do you have any recommendations for using you kits in this manner?
We use BAPNA to test for residual trypsin activity. How does your kit compare?
Do you have a clinical grade trypsin?
What type of samples are compatible with your assays? Is there any sample preparation required?
At what stage(s) of the production cycle should you test for residual enzymes?

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June 2017

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Industry Issues (11)
Downstream Bioprocessing (37)