This document outlines 10 hot topics in biomanufacturing: 1) product mix and business models in biopharma, 2) high-titer processes in mammalian cell culture, 3) downstream processing being driven by mass rather than volume, 4) facility fit considerations, 5) cost of goods and price margin pressures, 6) biosimilars and biobetters, 7) offshore manufacturing, 8) technology platforms and implications of high titer, 9) emerging technologies for biomass removal and contaminant clearance, and 10) single-use technologies and integrated processing. The speaker concludes by emphasizing the need for new perspectives and solutions to address challenges in biomanufacturing.
This presentation has been moved. To view this presentation, please visit http://pubs.acs.org/iapps/liveslides/pages/index.htm?mscNo=jz300725d
Vibrational Circular Dichroism Shows Reversible Helical Handedness Switching in Peptidomimetic lValine Fibrils
This presentation has been moved. To view this presentation, please visit http://pubs.acs.org/iapps/liveslides/pages/index.htm?mscNo=jz300725d
Vibrational Circular Dichroism Shows Reversible Helical Handedness Switching in Peptidomimetic lValine Fibrils
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Presentation at ACS Spring 2022 conference.
Recently, there has been a flood of cannabidiol (CBD)-containing products, with divers marketing claims for a plethora of use cases. With this new market segment, regulatory oversight is still developing, and label claims of CBD concentration is often verifiable. CBD is unstable in solution and some CBD products are anecdotally reported to turn purple on storage; however, the decomposition products of CBD are mostly unknown.
Delic Lab embarked on a long and painstaking hunt for those decomposition products, established their identity through complementary chemical methods and established reaction pathways between them.
We will present our findings about common CBD oxidation products, who those are highly photochemically unstable and decomposes rapidly. Decomposition leads to a multitude of new cannabinoid derivatives.
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While the actual THC concentration can vary between 70 and 95%, what is common for all cannabis concentrates is that the total of identified compounds seldomly goes above 95% of product weight.
Delic Labs is a research venture that seeks to add fundamental scientific insight to the field of cannabis and mushroom production. In this regard, we set out to identify those compounds in the missing mass balance for cannabis concentrates. This presentation will show our latest advances in characterizing and quantifying impurities in cannabis concentrates. For example, we found reduced cannabinoid species in CBN products, THC isomers in distillates and oxidation products in CBD formulations.
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Authors:
Tobias Wheeler, Lucy Sun, Rajendra Singh, Bahram Fathollahi and Hans Pirard
Affiliations:
PerkinElmer (Caliper), Alameda, CA, USA
For further information on the Microfluidics Technology (PerkinElmer) presented in this poster, please visit http://bit.ly/12j68ol
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The recombinant ligand that is linked to the well proven methacrylic polymer backbone of TOYOPEARL media has been engineered to maintain capacity even after repeated exposure to alkaline solution. Its multipoint attachment to the TOYOPEARL matrix further enhances chemical and thermal stability. In practice this pays off for a low level of Protein A leaching and also for a high resistance to alkaline solutions applied in cleaning-in-place (CIP) procedures. Due to its rigid polymer matrix TOYOPEARL AF-rProtein A HC-650F also provides excellent pressure flow characteristics.
Protein A resins constitute a substantial cost in state-of-the-art mAb purification processes. Factors such as operating cycles, capacity, and mAb titer can have an impact on total costs associated with mAb purification. The high capacity of the new TOYOPEARL AF-rProtein A HC-650F resin and its high alkaline resistance increase product throughput, reduce operating costs and increase manufacturing productivity.
Maak van socialmedia geen gemiste kans! Met je juiste strategie kun je socialmedia voor, tijdens en na je event perfect inzetten en zo een recurring event in gang zetten
Deep Purple: Discolouration in CBD productsMarkus Roggen
Presentation at ACS Spring 2022 conference.
Recently, there has been a flood of cannabidiol (CBD)-containing products, with divers marketing claims for a plethora of use cases. With this new market segment, regulatory oversight is still developing, and label claims of CBD concentration is often verifiable. CBD is unstable in solution and some CBD products are anecdotally reported to turn purple on storage; however, the decomposition products of CBD are mostly unknown.
Delic Lab embarked on a long and painstaking hunt for those decomposition products, established their identity through complementary chemical methods and established reaction pathways between them.
We will present our findings about common CBD oxidation products, who those are highly photochemically unstable and decomposes rapidly. Decomposition leads to a multitude of new cannabinoid derivatives.
Out of the Shadows: Identifying Impurities in Cannabis ProductsMarkus Roggen
Highly concentrated cannabis products have seen rapid growth, as customers become more accustomed to cannabis consumption and actively seek out high-potency products. Cannabis concentrates come in various forms and product names, from Badder, Budder and Crumble to Distillate, Oil and Shatter. Those products can have THC concentrations are high as 95%, compared with less than 25% common in cannabis flower.
While the actual THC concentration can vary between 70 and 95%, what is common for all cannabis concentrates is that the total of identified compounds seldomly goes above 95% of product weight.
Delic Labs is a research venture that seeks to add fundamental scientific insight to the field of cannabis and mushroom production. In this regard, we set out to identify those compounds in the missing mass balance for cannabis concentrates. This presentation will show our latest advances in characterizing and quantifying impurities in cannabis concentrates. For example, we found reduced cannabinoid species in CBN products, THC isomers in distillates and oxidation products in CBD formulations.
High-Throughput Screening of mAb Charge Variants Using Microchip-CZEPerkinElmer, Inc.
This poster describes the development of a high-throughput microchip-CZE assay for profiling the charge variants of therapeutic mAbs.
Authors:
Tobias Wheeler, Lucy Sun, Rajendra Singh, Bahram Fathollahi and Hans Pirard
Affiliations:
PerkinElmer (Caliper), Alameda, CA, USA
For further information on the Microfluidics Technology (PerkinElmer) presented in this poster, please visit http://bit.ly/12j68ol
High capacity chromatography resin for the capture and purification of monoclonal antibodies
Tosoh Bioscience, a provider of chromatographic solutions for the isolation and analysis of biomolecules, introduced a new Protein A chromatography resin designed for the purification of monoclonal antibodies (mAbs). It is well-suited for high capacity capturing of immunoglobulin out of high titer feedstock. TOYOPEARL AF-rProtein A HC-650F achieves 30% to 50% greater antibody adsorption than similar products. It exhibits dynamic binding capacities of greater than 70 g/L at residence times of 5 minutes and greater than 50 g/L at residence times of 2 minutes with feedstock titers from 1 g/L to more than 10 g/L.
The recombinant ligand that is linked to the well proven methacrylic polymer backbone of TOYOPEARL media has been engineered to maintain capacity even after repeated exposure to alkaline solution. Its multipoint attachment to the TOYOPEARL matrix further enhances chemical and thermal stability. In practice this pays off for a low level of Protein A leaching and also for a high resistance to alkaline solutions applied in cleaning-in-place (CIP) procedures. Due to its rigid polymer matrix TOYOPEARL AF-rProtein A HC-650F also provides excellent pressure flow characteristics.
Protein A resins constitute a substantial cost in state-of-the-art mAb purification processes. Factors such as operating cycles, capacity, and mAb titer can have an impact on total costs associated with mAb purification. The high capacity of the new TOYOPEARL AF-rProtein A HC-650F resin and its high alkaline resistance increase product throughput, reduce operating costs and increase manufacturing productivity.
Maak van socialmedia geen gemiste kans! Met je juiste strategie kun je socialmedia voor, tijdens en na je event perfect inzetten en zo een recurring event in gang zetten
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ELN use at Merck
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Company
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• Cross-Disciplinary Integration Via Comprehensive
Informatics Environments, A Case Study In Bridging
Discovery And Pre-Clinical Development
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We know we want to create products which our customers find to be valuable. Whether we label it as customer-centric or product-led depends on how long we've been doing product management. There are three challenges we face when doing this. The obvious challenge is figuring out what our users need; the non-obvious challenges are in creating a shared understanding of those needs and in sensing if what we're doing is meeting those needs.
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Industry expert Scott Sehlhorst will:
• Introduce a taxonomy for user goals with real world examples
• Present the Onion Diagram, a tool for contextualizing task-level goals
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1. “10 Hot Topics in Biomanufacturing”
Vienna, May 20th 2010
Dr. Uwe Gottschalk, VP Purification Technologies,
Sartorius Stedim Biotech
2. Hot Topic 1: Product Mix, Growth Rates in Business Modells in Biopharma
3. Hot Topic 1: Product Mix, Growth Rates in Business Modells in Biopharma
4. Hot Topic 1: Product Mix, Growth Rates in Business Modells in Biopharma
5. Hot Topic 2: High-Titer Processes in Mammalian Cell Culture
Data adapted from: F. Wurm Production of recombinant Protein Therapeutics
in Cultivated Mammalian Cells. Nature Biotechnology 22, 1-6 (2004)
6. Hot Topic 2: High-Titer Processes in Mammalian Cell Culture
7. Hot Topic 3: Downstream Processing is Mass- not Volume Driven
6th Annual Survey of Biopharmaceutical Manufacturing.
Eric S. Langer, BioPlan Associates Inc.
8. Hot Topic 3: Downstream Processing is Mass- not Volume Driven
Jim Davis, Lonza Economics of Monoclonal Antibody Production: The relationship between upstream titer and
downstream costs; IBC San Diego March 2008
9. Hot Topic 4: Facility Fit
Dr. Christian Eckermann, Boehringer Ingelheim 2007
10. Hot Topic 5: COGs and Price – Margin pressure from both sides
Technical challenge
Sensitive and technically demanding products require processes with inherent
complexity and expensive infrastructure
Need for robust & scalable processes for the entire DSP
Increasing regulatory scrutiny (Comparability!)
Financial challenge
Processes are fixed-cost driven (Investment vs Consumables)
Manufacturing costs 15 - 25% of sales price
Costs for DSP up to 75% of manufacturing costs
Cost Balance Benefit for innovative treatments
Biosimilars
11. Hot Topic 5: COGs and Price – Margin pressure from both sides
Biomanufacturing is fixed cost driven
Category
MAb manufacturing: 6 x 2,000L tanks, 2g/L, 90% utilisation; 211 #/a; 527 kg/yr; invest 172 Mio Euro;
142 $/g; Sinclair 2006
15. Hot Topic 8: Technology Platforms
Cell Removal/
Cell Removal/ Intermediate
Intermediate Virus
Virus
Fermentation
Fermentation Capturing
Capturing Polishing
Polishing
Clarification
Clarification Purification
Purification Clearance
Clearance
Microorg. CEX HIC Size-Exclusion
Size-Exclusion
BHK X-FLow Mixed-Mode Ceramic HA AEX (B/E)
CHO
CHO Centrifuge
Centrifuge CEX Inactivation
Human Depthfilter
Depthfilter Protein A
Protein A Gelfiltration AEX (FT)
Hybridoma EBA AEX-Membrane
AEX-M Adsorption
CHO Centr./DF New Aprocess CEX
Protein AEX (FT) Orthogonal
New process train
train
New process train ready K. Konstantinov
Bayer Corp, USA
16. Hot Topic 8: Technology Platforms– High Titer Implications in DSP
Media
Preparation
Increasing biomass and
contaminant levels
Protein A pool volumes Final
and step cost concentration /
buffer exchange
Virus Removal
DNA & HCP levels post
Capturing
Polishing load volumes Fermentation
and conductivity Cell Removal/
Clarification
Concentration
Capturing Polishing
18. Hot Topic 9: Emerging Technologies
Biomass Removal and Early Contaminant Clearance
addresses:
Increasing biomass and
contaminant levels
DNA & HCP levels post
Capturing
• New generation of lenticular
filtration media
• No Diatomeaceous Earth;
Synthetic
• Cell removal, clarification &
early on contaminant removal
19. Hot Topic 9: Emerging Technologies
Three Birds – one Stone: Contaminant Precipitation at Medarex addresses:
(now part of BMS) Fig 7a. precipitation based process Fig 7b. TFF based process
Contaminant Protein A pool volumes
TFF
precipitation and step cost
DNA & HCP levels post
CEX HCP < 10ng/mg Capturing < 1000 ng/mg
CEX HCP
Dilution Polishing load volumes
Dilution
and conductivity
Q Membrane Q Membrane HCP < 1000 ng/mg
HCP BDL 2 g/ml
20 g/ml
Dilution
VF
Mix Mode
Precipitation of Process-Derived Impurities in Non-Protein A VF
Purification Schemes for MAb; J. Wang et al. BioPharm Intl. 10/2009, 2-9
20. Hot Topic 10: Single Use Technologies and „Integrated Processing“
21. Hot Topic 10: Single Use Technologies and „Integrated Processing“
22. Hot Topic 10: Single Use Technologies and „Integrated Processing“
J. Zhou BPI Vienna 2008
23. Summary: Biomanufacturing 2010+
“The real voyage of discovery consists not
in seeking new landscapes
but in having new eyes.”
Marcel Proust.