Ask The Expert
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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?
Podcasts
- Automated Stem Cell Based High Throughput Drug Screening for ALS and Parkinson’s Disease
- Cell Culture Media Optimization – It’s about more than just high protein titer
- Job Outlook for the Biomanufacturing Industry
- Resolving large scale buffer management challenges
- Protein A Chromatography – A look at where we have been and where we are going
- Addressing Challenges in Downstream Biomanufacturing with a platform purification approach
- Continuous Biomanufacturing Implementation Now and in the Future
- Cell Harvesting – Selecting a technology compatible with cell density and feed turbidity
- Modeling Downstream Disruptive Technologies to Improve Downstream Bioprocessing
- Start With the End in Mind – How to facilitate transfer from non-GMP to GMP Manufacturing
Cool Tools
- Residual Enzyme Testing – All in one Assay Kits for Liberase and Trypsin
- Clarification using Acoustic Wave Separation offers Advantages including -Continuous Process Solution
- Aramus Single Use Bag Assembly – Provides Advantages over Existing Storage and Transportation of Intermediate and Drug Substance
- Cadence Single Pass TFF Provides in-line Concentration, Enables Continuous process
- SCOUT® technology reduces time to market and increases chance of success for biopharmaceutical products
- Lynx® CDR Connectors to Improve Sterile Fluid Transfer in Biomanufacturing
- New KANEKA KanCapA™ 3G for Improved Binding and Milder Elution of Therapeutic Antibodies
- Scale up with confidence – Introducing ReadyToProcess 32 L (450/200)
- Pre-activated Resins for Ligand Immobilization to facilitate the Creation of Customized Affinity Purification Media
- Optimize Changeover Workflows with ÄKTA readyflux – An Automated, Single-use Crossflow Filtration System
- Direct vs. indirect methods for characterization and analysis of subvisible particles – A comparative study
- Achieve Integrated and Scalable Continuous Chromatography
- ‘Jetting’ technology for manufacturing agarose beads with enhanced performance characteristics
- Optimize downstream processing with single-pass inline concentration
- Intensify process development steps and simplify transfer to GMP environment with new ÄKTA pilot 600 chromatography system
- Cool Tool – Inline Diafiltration Closes the Gap for End-to-End Continuous Bioprocessing
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Pages
Posts
- Integrity Testing of Flexible Container Using the Helium Integrity Testing (HIT) Platform (2-D and 3-D Bags and Manifolds)
- Lab Management Systems – A discussion on keeping your lab running at peak efficiency
- Vaccines – An interesting discussion of past, present and future
- Bioprocess International Conference – Tuesday’s Talks
- Biological Contamination– A discussion about reducing risks
- Development and Characterization of a LONG R3IGF‐1 ELISA
- Implementing Disposable Chromatography: Technology Fit in Downstream Purification
- CaptureSelect Technology: Introducing One-Step Selectivity in the Purification of Biological Products
- Innovative Downstream Cell Culture Products and Great Posters Featured at the Bioprocess International Conference – Part III
- GE Healthcare Completes Acquisition of Three Thermo Fisher Scientific Business Divisions
- Serum Use – Methods and Considerations for Successful Use in Cell Culture
- PCR Release Testing for Mycoplasmas Gaining Ground versus Conventional Methods
- 3D cell culture set for space HD
- Biologics Development: How do you Solve a Problem Like Data Management?
- Continuous Downstream Processing – A Tool to Address Key Manufacturing Challenges
- UPDATED – A New Model for Continuous Processing in Downstream Purification
- Continuous Bioprocessing – The Biomanufacturing Model of the Future?
- New Report Forecasts Sustained Growth in the Pharmaceutical Market through 2020
- Protein A – Evolution and Optimization Strategies
- Going to the BioProcess International Conference? Don’t miss these exciting activities!
- The Future of Biopharmaceutical Manufacturing – Solutions to Address Industry Challenges
- BioProcess International Conference (BPI) 2015 – An Overview For Anyone Who Missed It!
- Biomanufacturing Innovations are Plentiful at This Year’s BPI Conference
- Evaluating Plastic Film for Single-Use Technologies in Biomanufacturing
- BPI West 2016 – BioProcess International Conference – In case you missed it!
- Poster: Purpose-designed Protein A resins for Improved Downstream Process and Cost Efficiency in MAb purification
- Ensuring Removal of Residual Enzymes in Biomanufacturing – Trypsin and Collagenase
- BIO 2016 Annual Convention – A Summary of Highlights
- Utilizing UVC LEDs in Biotech and Pharma – Paving the way to better instrument design and better manufacturing methods
- Boston Biotech Week 2016 – Downstream Coverage – In case you missed it!
- Gain Productivity in Protein Purification through Column Loading Optimization
- 2016 BioProcess International Award Winners – Downstream and Facilities
- Optimization of a Protein A Chromatography Process for a Herceptin® Biosimilar (Trastuzumab)
- The Top 10 Downstream Column Blogs in 2016
- Affordable Biologic Downstream Purification with Single-Use Protein A Membrane
- Lowering MAb Clinical Trial Material Manufacturing Costs with Purpose-designed Protein A Chromatography Resins – A Case Study
- Increasing Downstream Bioprocess Efficiency and Overcoming Bottlenecks
- A Look at the Current State of Continuous Bioprocessing
- Continuous Processing Optimization with Smarter Tools
- Fortem: A platform film built for bioprocess
- FDA CDER Novel Biologic Drug Approvals 2016
- Addressing Buffer Bottlenecks using automated In-line conditioning and ready-made stock solutions for mAb processes
- Antibody Fragment Purification Platform
- Cost and impact of a bioburden incident
- Subvisible Particle Characterization: Why Simply Counting Shadows Leaves You in the Dark
- Automated Adenovirus Purity Analysis Speeds Viral-based Gene Therapy Process Development
- Continuous bioprocessing – moving from theory to reality
- Fine Tuning Viral Clearance Approaches with a Total Viral Challenge Strategy
- Impact of Continuous Chromatography Mode on Protein A Resin Lifetime
- Bioburden Contamination in Downstream Bioprocesses – Potential entry points for contamination and innovative solutions
- Automated, single-use filtration to increase efficiency in upstream and downstream operations
- 2017 Biotech Week Boston – Downstream Coverage Highlights
- Enabling Antibody-drug conjugate manufacturing using single-use systems in downstream – Extractables study demonstrates a good fit
- Downstream Bioprocessing Cost Modeling – Looking at Integrated Continuous, Single-use and Stainless Steel Platforms
- The Top 25 Downstream Column Blogs of 2017
- Utilizing a Protein A Resin Platform Approach for Purification of Antibody Fragments and Single Domain Antibodies Reduces Process Time
- Validation of Virus Filtration in Continuous Bioprocessing
- Global Downstream Bioprocessing Market Expected to Demonstrate Significant Growth
- Integrating Downstream Unit Operations – Polishing and Concentration Steps
- Flexible Downstream Platform Facilitates Adaptation to Scale
- Video – Viral Safety in Biologics Manufacturing
- Implementing Process Analytical Technology (PAT) in Continuous Bioprocessing
- Impurity Precipitation Strategies for Intensification of mAb Downstream Processes
- Continuous biomanufacturing – Key drivers for adoption, economic modelling and regulatory considerations
- How Robots Are Changing The Landscape Of The Medical Field
- Downstream Manufacturing of Gene Therapy Vectors
- A Guide for Selecting the Correct Filter Integrity Test Instrument
- Rapid Characterization of Virus Like Particles Informs Vaccine and Gene Therapy Downstream Processes
- Monolithic Chromatography Enables Process Intensification of Virus Purification
- High Throughput Process Development in Biomanufacturing – Current Challenges and Benefits
- Designing a Viral Clearance Study – A Step by Step Tutorial
- Utilizing High-Throughput Process Development Tools to Create a Purification Process for a Biosimilar Molecule
- Scalable Protein A Chromatography for High-Throughput Process Development
- Optimizing mAb Purification with Highly Selective Mixed-mode Cation Exchange Sorbent
- Cool Tool – Innovative sorbents enable a robust and streamlined protein purification process
- Bioburden Control Strategies for Continuous Downstream Processing
- Supplier Qualification and Material Selection – A Case Study of Biopharmaceutical Resin Manufacture
- Novel affinity resins enabling the purification of next generation antibody fragments: KANEKA KanCap™ G and KanCap™ L
- Viral Filtration Validation Study Design – A Systematic Method for Choosing the Most Appropriate Test Approach
- Automated Buffer Preparation – Increasing Production Capacity While Maintaining Footprint
- Top Downstream Process Articles of 2019
- Innovative Single-Use Freeze and Thaw Platform for Bulk Drug Substance
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