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Upstream

RELATED TOPICS

 * Bioreactors
 * Biochemicals/Raw Materials
 * Cell Culture Media

 * Expression Platforms
 * Microbial Cell Culture
 * Perfusion Cell Culture

RECENT IN UPSTREAM

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Bispecific Antibodies Unleashed
Sponsored Content
Bispecific Antibodies UnleashedBispecific Antibodies Unleashed
byBPI Contributor
Nov 2, 2023
1 Min Read
Working Toward an AAV Platform: Challenges, Threats, and Opportunities
Sponsored Content
Working Toward an AAV Platform: Challenges, Threats, and OpportunitiesWorking
Toward an AAV Platform: Challenges, Threats, and Opportunities
byMégane Denu, Quentin Bazotand 1 more
Oct 20, 2023
Downstream

RELATED TOPICS

 * Chromatography
 * Filtration

 * Separation/Purification
 * Viral Clearance

RECENT IN DOWNSTREAM

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A Scalable Single-Use Two-Step Plasmid Purification Process
Sponsored Content
A Scalable Single-Use Two-Step Plasmid Purification ProcessA Scalable Single-Use
Two-Step Plasmid Purification Process
byBPI Contributor
Nov 3, 2023
20 Min View
Minimizing Lentiviral Vector Loss During the Purification Process Using an
Innovative Nanofiber Adsorbent
Sponsored Content
Minimizing Lentiviral Vector Loss During the Purification Process Using an
Innovative Nanofiber AdsorbentMinimizing Lentiviral Vector Loss During the
Purification Process Using an Innovative Nanofiber Adsorbent
byBPI Contributor
Oct 31, 2023
20 Min View
Manufacturing

RELATED TOPICS

 * Biosimilars
 * Continuous Bioprocessing
 * Facility Design/Engineering
 * Formulation
 * Single Use
 * Fill/Finish

 * Information Technology
 * Process Monitoring and Controls
 * Supply Chain
 * Validation
 * CMC Forums

RECENT IN MANUFACTURING

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Bioprocess Insider
Breyanzi: BMS seeking to expand outreach of lymphoma therapyBreyanzi: BMS
seeking to expand outreach of lymphoma therapy
byJosh Abbott
Aug 22, 2024
3 Min Read
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Bioprocess Insider
Fujifilm expands UK manufacturing space with one eye on the futureFujifilm
expands UK manufacturing space with one eye on the future
byJosh Abbott
Aug 22, 2024
2 Min Read
Analytical

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 * QA/QC
 * Cell Line Development
 * PAT
 * Product Characterization

 * Bioanalytical Methods
 * Process Development
 * Assays
 * Laboratory Equipment

RECENT IN ANALYTICAL

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Test - Juan - Article
Analytical
Test - Juan - ArticleTest - Juan - Article
byAdrianna Milewska
May 3, 2024
1 Min Read
The Key Role of Analytical Methods in Technology Transfer
Sponsored Content
The Key Role of Analytical Methods in Technology TransferThe Key Role of
Analytical Methods in Technology Transfer
byOlena Chervonenko
Oct 17, 2023
Business

RELATED TOPICS

 * Bioregions
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 * Pre-Clinical & Clinical Trials
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RECENT IN BUSINESS

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Bioprocess Insider
Key strategies for effective technology evaluationKey strategies for effective
technology evaluation
byKim Bennett
Aug 8, 2024
2 Min Read
Resilience logo
Sponsored Content
Built to Serve Innovation: A Briefing on Commercial Readiness at ResilienceBuilt
to Serve Innovation: A Briefing on Commercial Readiness at Resilience
byBPI Contributor
Jun 25, 2024
15 Min View
Therapeutic Modalities

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 * Cell Therapies
 * Emerging Therapeutics
 * Gene Therapies
 * Large Molecule Development

 * MAb
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RECENT IN THERAPEUTIC MODALITIES

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Bioprocess Insider
Biomanufacturing in space accelerating therapy development on
EarthBiomanufacturing in space accelerating therapy development on Earth
byJosh Abbott
Jul 24, 2024
3 Min Read
DNA Synthesis: Chemical, Enzymatic, or Both?
Therapeutic Modalities
DNA Synthesis: Chemical, Enzymatic, or Both?DNA Synthesis: Chemical, Enzymatic,
or Both?
byMark Behlke
Oct 20, 2023
BioProcess Insider

RELATED TOPICS

 * Deal-Making
 * Facilities & Capacity
 * Global Markets
 * Regulations

 * Therapeutic Class
 * Upstream & Downstream Processing
 * Webcasts
 * BioProcess Insider Podcasts

RECENT IN BIOPROCESS INSIDER

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LumaCyte
Sponsored Content
LumaCyte Unveils Predictive CAR T Donor Analytics to Revolutionize Cell Therapy
ManufacturingLumaCyte Unveils Predictive CAR T Donor Analytics to Revolutionize
Cell Therapy Manufacturing
byBPI Contributor
Sep 18, 2024
3 Min Read
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Facilities & Capacity
Symbiosis doubles Scotland footprint with $34m investmentSymbiosis doubles
Scotland footprint with $34m investment
byShreeyashi Ojha
Sep 9, 2024
2 Min Read




INSIDER NEWS


NOW OPEN: MILLIPORE’S MARYLAND FACILITY SLASHES VIRUS TESTING TIME

Oct 9, 2024


ALLTERUM PARTNERS WITH GBI TO MANUFACTURE MAB FOR CLINICAL TRIAL

Oct 9, 2024


OPENCELL AND ADVA PARTNERSHIP SEEKS TO IMPROVE CGT MANUFACTURING

Oct 9, 2024


RECIPHARM AND EXELA COLLABORATE TO BOOST US STERILE INJECTABLE PRODUCTION

Oct 9, 2024
Read More
people in hazmat suits
Vaccines


THE POWER OF UNIVERSAL VACCINES IN THE FIGHT AGAINST BIOLOGICAL WARFARE


THE POWER OF UNIVERSAL VACCINES IN THE FIGHT AGAINST BIOLOGICAL WARFARE

Sep 1, 2024
bioreactor
Bioreactors
Lessons in Bioreactor Scale-Up: Part 3 — Experimental Determination and
Application of Oxygen Mass- Transfer Rate, Mass-Transfer Coefficient, and
Oxygen-Uptake Rate
Lessons in Bioreactor Scale-Up — Part 3: Experimental Determination and
Application of Oxygen Mass- Transfer Rate, Mass-Transfer Coefficient, and
Oxygen-Uptake Rate

Sep 9, 2024

Continuous Bioprocessing
Controlling Integrated, Continuous Processes: Real-Time Monitoring with
Feed-Back and Feed-Forward Controls Enables Synchronization and Enhances
Robustness
Controlling Integrated, Continuous Processes: Real-Time Monitoring with
Feed-Back and Feed-Forward Controls Enables Synchronization and Enhances
Robustness

Sep 22, 2024




BIOPROCESS INSIDER DAILY - BIOTECH WEEK BOSTON

Read More

Therapeutic Class
Vertex adds Lonza to cautious Casgevy commercial network

Vertex says finding the sweet spot in manufacturing capacity is key to ensuring
the successful rollout of sickle cell gene therapy Casgevy (exagamglogene
autotemcel).

Global MarketsWhite House OSTP: ‘Whether Harris or Trump, biomanufacturing is
bipartisan’

A President Biden Executive Order supporting homegrown biomanufacturing will
remain in place whoever wins in November, White House OSTP assistant director
Sarah Glaven told Biotech Week Boston delegates.

Facilities & CapacityResilience opens doors to showcase former Sanofi plant to
BWB delegates

CDMO Resilience hosted visitors at its Boston manufacturing site during Biotech
Week Boston.

Upstream & Downstream ProcessingUnderstanding scope is key to tackling
bioproduction tech challenges, say experts

Defining industry-wide problems and collaboratively solving them remain key for
the industry, according to delegates discussing technology implementation at
Biotech Week Boston.


LATEST ISSUE

September 2024 Issue

Current Issue



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Process Monitoring and Control: Data-Powered Operations for Drug Quality

Featured Report



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Special Report

From Pipettes to Infusion Pumps: Volume Accuracy in Regulated Industries and Its
Critical Impact



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Archive


Upstream Processing

BPI Theater panelists
Expression Platforms
Improving Expression and Manufacturing of Novel Biologics
Improving Expression and Manufacturing of Novel Biologics

Jul 31, 2024

turbulent flow image
Bioreactors
Lessons in Bioreactor Scale-Up, Part 2: A Refresher on Fluid Flow and Mixing
Lessons in Bioreactor Scale-Up, Part 2: A Refresher on Fluid Flow and Mixing

Jun 12, 2024


Sponsored Content
Empowering Biologic Breakthroughs: Transforming Tomorrow’s Healthcare Landscape
Through Microbial-Based Development and Manufacturing
Empowering Biologic Breakthroughs: Transforming Tomorrow’s Healthcare Landscape
Through Microbial-Based Development and Manufacturing

Mar 28, 2024


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Downstream Processing

quantitative venn diagram
Sponsored Content
LC-MS Detection of Host Cell Proteins: Antibody Affinity Extraction Sample
Preparation Outperforms Native Digestion
LC-MS Detection of Host Cell Proteins: Antibody Affinity Extraction Sample
Preparation Outperforms Native Digestion

Jul 29, 2024

Simplifying Downstream Processing: Innovative Solutions for Filtration and
Chromatography Cover
Sponsored Content
Simplifying Downstream Processing: Innovative Solutions for Filtration and
Chromatography
Simplifying Downstream Processing: Innovative Solutions for Filtration and
Chromatography

Jun 12, 2024


Navigating Biotherapeutic Complexity: Tailored Chromatography Resins to Enable
Purification Success
Sponsored Content
Navigating Biotherapeutic Complexity: Tailored Chromatography Resins to Enable
Purification Success
Navigating Biotherapeutic Complexity: Tailored Chromatography Resins to Enable
Purification Success

Jun 12, 2024


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Manufacturing

eBook cover
Sponsored Content
eBook: Drug Delivery — New Formats for Novel Biopharmaceuticals
eBook: Drug Delivery — New Formats for Novel Biopharmaceuticals

Jun 26, 2024

buffer design workflow
Information Technology
Buffer Design for Biopharmaceutical Processes: An Online Tool for Designing and
Understanding Buffers
Buffer Design for Biopharmaceutical Processes: An Online Tool for Designing and
Understanding Buffers

Jun 19, 2024


digital globe
Information Technology
Keys to Successful Technology Transfer
Keys to Successful Technology Transfer

Jun 12, 2024


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Analytical

Cell Therapies
Analytical Considerations for Gene-Modified Hematopoietic Stem and Progenitor
Cell Therapies: Part 1 — In-Process and Drug Product Control
Analytical Considerations for Gene-Modified Hematopoietic Stem and Progenitor
Cell Therapies: Part 1 — In-Process and Drug Product Control
QA/QC
Practical Applications of Process Capability Indices in the Biopharmaceutical
Industry: A Simulation-Based Study
Practical Applications of Process Capability Indices in the Biopharmaceutical
Industry: A Simulation-Based Study

Corrective and preventive actions
QA/QC
Determining Sample Size for Demonstrating Zero Failures: Ensuring the
Effectiveness of Corrective and Preventive Actions
Determining Sample Size for Demonstrating Zero Failures: Ensuring the
Effectiveness of Corrective and Preventive Actions

View More

Business

scientist at computer
Bioregions
US–India Collaborative Innovations for Rapid Drug Discovery
US–India Collaborative Innovations for Rapid Drug Discovery
Outsourcing — India's Burgeoning Biologics CDMO Marketplace eBook Cover
Sponsored Content
eBook: Outsourcing — India's Burgeoning Biologics CDMO Marketplace
eBook: Outsourcing — India's Burgeoning Biologics CDMO Marketplace

business man in choppy waters
Economics
Navigating Choppy Waters: Three Resilient Marketing Tactics for Biotechnology
Companies amid Market Turmoil
Navigating Choppy Waters: Three Resilient Marketing Tactics for Biotechnology
Companies amid Market Turmoil

View More

Therapeutic Modalities

handshake
Cell Therapies
Elevating the CGT Manufacturing Game: How Outsourcing Enables Success
Elevating the CGT Manufacturing Game: How Outsourcing Enables Success
Allogeneic Cell Therapy eBook cover
Sponsored Content
eBook: Allogeneic Cell Therapy — From Clinical Concept to Viable Product
eBook: Allogeneic Cell Therapy — From Clinical Concept to Viable Product

Macroscopic macrophage image
Emerging Therapeutics
A Milestone in Macrophage-Based Cancer Treatment: Leveraging Chimeric Antigen
Receptors To Address Solid Tumors
A Milestone in Macrophage-Based Cancer Treatment: Leveraging Chimeric Antigen
Receptors To Address Solid Tumors

View More


LATEST EBOOKS

See All
Facility Design/EngineeringeBook: Sustainable Facilities — Emerging Approaches
to Design and ConstructioneBook: Sustainable Facilities — Emerging Approaches to
Design and Construction



Cell TherapieseBook: Challenges of Commerical-Scale Autologous CAR-T Cell
ManufacturingeBook: Challenges of Commerical-Scale Autologous CAR-T Cell
Manufacturing



Fill/FinisheBook: Drug Delivery — New Formats for Novel BiopharmaceuticalseBook:
Drug Delivery — New Formats for Novel Biopharmaceuticals






Special Reports


Sponsored Content
Scaling Up mAb Production with a Platform Medium and Feed SystemScaling Up mAb
Production with a Platform Medium and Feed System

As the monoclonal-antibody (mAb) market continues to grow, it is becoming
increasingly important for pharmaceutical and biotech companies to accelerate
process development and establish a scalable manufacturing process capable of
achieving high titers and consistent product quality. Central to this is a cell
culture media and feed system that can provide the required nutrients for
optimal cell growth, viability, and function, as well as facilitate a seamless
transition from development to clinical and commercial manufacturing. However,
choosing an appropriate system can be a complex and time-consuming process,
often requiring the evaluation of multiple medium and feed options. Platform
systems, consisting of a medium and complementary feed developed for a specific
cell line and application, have emerged as a valuable option for developers to
help simplify selection and increase scale-up efficiency. To meet the need for
high-performance platform mAb manufacturing solutions, Thermo Fisher Scientific
has dev...

Sponsored Content
From Pipettes to Infusion Pumps: Volume Accuracy in Regulated Industries and Its
Critical ImpactFrom Pipettes to Infusion Pumps: Volume Accuracy in Regulated
Industries and Its Critical Impact

Precision in volume delivery is critically important for both the
biopharmaceutical and medical device industries. This special report discusses
how accurate volume measurement affects patient safety, product quality, and
regulatory compliance. Sartorius emphasizes the roles that infusion pumps,
laboratory pipettes, and quality control (QC) measures play in ensuring reliable
and reproducible results. Register or Login and hit Download Now to get the full
Special Report.

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Ask the Expert Webcasts


Sponsored Content
Developing Efficient Downstream Purification Processes for Bispecific
AntibodiesDeveloping Efficient Downstream Purification Processes for Bispecific
Antibodies

This webcast features: William H. Rushton, MS, Chromatography Support Scientist,
Process Chromatography, Bio-Rad Laboratories. In this webinar, learn about the
latest advancements in purification workflows for bispecific antibodies (bsAbs).
Downstream purification faces a major obstacle due to the intricate composition
of bsAbs, which frequently results in low yields and increased complexity.
 Purification strategies and technologies are being developed to overcome these
obstacles, aiming to improve the efficiency and scalability of bsAb purification
processes. Modern chromatographic resins can provide researchers with new
solutions to optimize their downstream processes and increase the production of
bsAbs for a variety of therapeutic applications.These advancements in
purification technologies can lead to higher purity levels and increased
productivity, ultimately benefiting the biopharmaceutical industry. This webinar
showcases a series of case studies that focus on purification strategies
utilizing...

Sponsored Content
Accelerating ADC Drug Development with Technology Innovation and an Integrated
PlatformAccelerating ADC Drug Development with Technology Innovation and an
Integrated Platform

This webcast features: Bingquan (Stuart) Wang, PhD, Senior Director, US-EU CMC
Management, WuXi XDC. Antibody-drug conjugate (ADC), is one of the fastest
growing fields in therapy for life-threatening diseases. Its novel mechanism of
action, target for unmet serious diseases and significant therapeutic effect has
led the expedited development and approval of several new ADC drugs. However,
ADC development presents unique and serious challenges. The combination of a
large molecule and a small molecule increases complexity and therefore slows
down progress. Producing the native antibody and the drug and linker requires
multiple processes, as does drug substance conjugation and drug product
manufacturing. Additionally, various assays are essential to support
manufacturing, characterization, and release and stability testing. Overcoming
these hurdles requires advanced CMC expertise and innovative technology. Key
Takeaways: Register or Login and hit Watch on Demand to view the recorded
webcast now.

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White Papers

Lonza licensing campaign
Sponsored Content
Optimization of Transient Protein Expression in CHO Cells
Optimization of Transient Protein Expression in CHO Cells


Millipore Emprove Banner
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Managing Nitrite Impurities: A Supplier Manufacturer Approach to Mitigating
Nitrosamine Risk
Managing Nitrite Impurities: A Supplier Manufacturer Approach to Mitigating
Nitrosamine Risk

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Sponsored Content
Harmonizing Regulatory Guidelines for Assay Validation: A Focus on
Kinetics-Based Assays
Harmonizing Regulatory Guidelines for Assay Validation: A Focus on
Kinetics-Based Assays
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Posters

Accelerating Cell Line Development with an Efficient, Combined Platform Approach
Sponsored Content
Accelerating Cell Line Development with an Efficient, Combined Platform Approach
Accelerating Cell Line Development with an Efficient, Combined Platform Approach
Evaluation Of a New Glucose Control Strategy Using CITSens Bio APC (Automated
Process Control) for CHO Fed-Batch Application
Sponsored Content
Evaluation Of a New Glucose Control Strategy Using CITSens Bio APC (Automated
Process Control) for CHO Fed-Batch Application
Evaluation Of a New Glucose Control Strategy Using CITSens Bio APC (Automated
Process Control) for CHO Fed-Batch Application



High Productivity and Process Economy in GxP Applications with the Octet™
Platform
Sponsored Content
High Productivity and Process Economy in GxP Applications with the Octet™
Platform
High Productivity and Process Economy in GxP Applications with the Octet™
Platform
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Videos

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Accelerating Process Development Through Rapid Aggregate Screening
Accelerating Process Development Through Rapid Aggregate Screening
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