THERMO BIOPROCESS ONLINE EVENT SHORTS
Clinical Trial Strategy And ADC Dev Partnership
As the Bioprocess Online Live panel discussion Accelerating ADC Process Development wraps up, expert panelists Dr. Léo Marx (Debiopharm), Dr. Monika Lamba Saini (ADC Therapeutics), and Dr. Philipp Spycher (Araris Biotech) address audience questions on AI-d...
ADC Heterogeneity, Site-Specific Conjugation
This busy segment of the Bioprocess Online Live panel discussion Accelerating ADC Process Development finds Dr. Léo Marx (Debiopharm), Dr. Monika Lamba Saini (ADC Therapeutics), and Dr. Philipp Spycher (Araris Biotech) addressing DAR variability and lipoph...
Linker And ADC Platform Manufacturing Technologies
In this segment from the Bioprocess Online Live panel discussion Accelerating ADC Process Development, Dr. Léo Marx (Debiopharm) addresses advances in linker technology before he, Dr. Monika Lamba Saini (ADC Therapeutics) and Dr. Philipp Spycher (Araris Bi...
Challenges In ADC Process Development
Where does ADC process development fail? In this segment from the Bioprocess Online Live panel discussion Accelerating ADC Process Development, expert panelists Dr. Monika Lamba Saini (ADC Therapeutics), Dr. Léo Marx (Debiopharm), and Dr. Philipp Spycher (...
AI In ADC Target Identification
How are AI and machine learning contributing to ADC target identification and early development? Dr. Monika Lamba Saini (ADC Therapeutics), Dr. Léo Marx (Debiopharm), and Dr. Philipp Spycher (Araris Biotech) tackle computational approaches to protein targets, clini...
ADCs & Speed To IND
In this opening segment from the Bioprocess Online Live panel discussion Accelerating ADC Process Development, expert panelists Dr. Monika Lamba Saini (ADC Therapeutics), Dr. Léo Marx (Debiopharm), and Dr. Philipp Spycher (Araris Biotech) frame up ADC deve...
Outsourcing Considerations For Novel Protein Therapeutics
Panelists discuss special considerations for outsourcing the development and manufacturing of novel, complex protein therapeutics in this Bioprocess Online Live event.
Addressing Aggregation And Degradation In Complex Protein Therapeutics
In this segment of the Bioprocess Online Live event Early Process Considerations For Novel Protein Therapeutics, panelists discuss using a transient expression platform to make fast early product attribute decisions.
When To Conduct Analytical Assays In Novel Protein Therapeutic Development
Panelists in the Bioprocess Online Live event discuss the various points at which analytical assays are most critical during complex protein therapeutic development.
IND Prep Versus Clinical/Commercial Scale-Up In Novel Protein Therapeutics
In this segment of the Bioprocess Online Live event Early Process Considerations For Novel Protein Therapeutics, panelists share detailed considerations for scale-up of complex protein therapeutics.
Addressing Post-Translational Modifications In Novel Protein Therapeutics
Meinhard Hasslacher, Ph.D., Head of CMC at SOTIO Biotech, addresses an audience question on conjugation efficiencies in this segment of the Bioprocess Online Live event Early Process Considerations For Novel Protein Therapeutics. From there, we move on to an audience-led ...
Key Attributes To Monitor During Cell Line Development Of Complex Proteins
In this segment of the Bioprocess Online Live event Early Process Considerations For Novel Protein Therapeutics, panelists discuss key attributes to monitor during cell line development processes.
Cell Line Selection In Novel Protein Therapeutic Development
Lena Tholen, Ph.D., and Meinhard Hasslacher, Ph.D., weigh in early on important cell line selection considerations for novel protein therapeutics in this segment of "Early Process Considerations For Novel Protein Therapeutics".
Three Novel Protein Therapeutic Worldviews
In this segment of the Bioprocess Online Live event Early Process Considerations For Novel Protein Therapeutics, we meet panelists who share their topline perspectives on developing complex, novel protein therapeutics.
What's Next For Bioprocess Intensification?
Experts speaking on Bioprocess Intensification In The Real World wrap up the Bioprocess Online Live event with parting shots and reflections on the current state of process intensification and what the future holds.
Considerations In Continuous Chromatography
In this segment of the Bioprocess Online Live event Bioprocess Intensification In The Real World, our presenters discuss considerations for continuous versus batch chromatography and compare notes on the approaches at their respective organizations.
What Analytics Drive Process Intensification?
Bioprocess Online Live panelists discuss the most fundamental analytics that inform and enable process intensification strategies in this segment of Bioprocess Intensification In The Real World.
Process Intensification Development Challenges At AZ and AbbVie
In this segment of the Bioprocess Online Live event Bioprocess Intensification In The Real World, panelists respond to audience questions about the challenges they’ve encountered while developing process intensification strategies.
Process Intensification Audience Q&A
Our panelists take audience questions on process intensification lessons learned from other industries.
Where Process Intensification Sits In The AbbVie, AstraZeneca Organizations
In this segment of the Bioprocess Online Live event Bioprocess Intensification In The Real World, panelists discuss where and how their roles in setting the course for process intensification sit within their greater organizations.
What Bioprocessing Bottlenecks Does Process Intensification Address?
Supply chains, consumables, and data are identified as three of the management challenges that intensified processes and process automation technology (PAT) are addressing at AbbVie and AstraZeneca.
Why AstraZeneca and AbbVie Are Intensifying Processes
In this segment of the Bioprocess Online Live event Bioprocess Intensification In The Real World, our speakers share the motivation for continued process intensification in their respective organizations.
IND Submission Advice From The Front Lines
NDA Partners Regulatory Affairs Expert Consultant Daniela Drago, Ph.D. and Umoja Biopharma VP of Regulatory Affairs Helen Kim share parting shots and nuggets of IND submission wisdom, and respond to a few final audience questions, in this final segment of the Bioprocess O...
Resources For Successful IND Submissions
In this segment of the Bioprocess Online Live event IND Success: Navigate Through The Regulatory Gray, NDA Partners Regulatory Affairs Expert Consultant Daniela Drago, Ph.D. and Umoja Biopharma VP of Regulatory Affairs Helen Kim offer several of their go-to resources for ...
So, You've Been Put On Clinical Hold…
As the frequency of clinical holds increases, so do the chances it’ll happen to you. What’s a biopharma leader to do if it happens? Umoja Biopharma VP of Regulatory Affairs Helen Kim and NDA Partners Regulatory Affairs Expert Consultant Daniela Drago, Ph.D. of...
How To Avoid A Clinical Hold
Umoja Biopharma's VP of Regulatory Affairs and an NDA Partners Regulatory Affairs Expert Consultant have come together to dig into how biopharmas can avoid clinical holds from the outset
IND Submissions Are On The Rise
During this segment of the Bioprocess Online Live event IND Success: Navigate Through The Regulatory Gray, we asked our live audience about their near-term IND submission plans. Our panelists, NDA Partners Regulatory Affairs Expert Consultant Daniela Drago, Ph.D. and Umoj...
The Impact Of The Clinical Hold
In this segment of the Bioprocess Online Live event IND Success: Navigate Through The Regulatory Gray, Umoja Biopharma VP of Regulatory Affairs Helen Kim and NDA Partners Regulatory Affairs Expert Consultant Daniela Drago, Ph.D. discuss the ramification...
Why Clinical Holds Happen
The volume of clinical holds doled out by the FDA has skyrocketed in recent years. In this segment of the Bioprocess Online Live event IND Success: Navigate Through The Regulatory Gray, NDA Partners Expert Consultant Daniela Drago, Ph.D. and Umoja Biopha...
Animal Testing & Tox: What's Required Today?
In this segment of the Bioprocess Online Live event IND Success: Navigate Through The Regulatory Gray, Umoja Biopharma VP of Regulatory Affairs Heln Kim entertains audience questions on FDA toxicology and animal study requirements in light of the Reducin...