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The Road to Biologics’ Continued Success
In a short period of time, biopharmaceuticals have had a tremendous impact on both the pharma industry and the lives of countless patients.
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Biologics: Driving Force in Pharma
Biologics actually accounted for six of the top eight drugs by revenues in 2016.
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Making Real-Time Process Analytical Technology In Biomanufacturing A Reality
Automated, aseptic sampling and analysis is a prerequisite for making real-time Process Analytical Technology (PAT) in biomanufacturing a commercial reality.
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Disease-In-A-Dish: Leveraging in vitro Human Models to Advance Drug Discovery
A personalized approach to the generation of therapeutics is gaining greater traction not only with medical personnel, but also with the patient.
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Speeding Development And Reducing Costs With Analytical Quality By Design
Applying Quality by Design (QbD) principles to analytical method development leads to many benefits.
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Implications of Serialization for the U.S. Pharma Industry
New requirements under the U.S. Drug Supply Chain Security Act (DSCSA) have been set for pharmaceutical manufacturers.
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Serialization: The First Steps In Sales Unit Traceability and Data Management
While initially driven by regulations, the impacts of serialization will be far-reaching.
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Supporting The Tech Transfer Continuum For Cell & Gene Therapies
Organizations that can support the continuum of tech transfer projects will be best positioned to meet the expanding needs of the marketplace.
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Propagating a Full Spectrum of Services for ADC Development and Manufacture
The development and manufacture of antibody-drug conjugates (ADCs) requires expertise in both biological drug substance and API technologies.
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Moving Quality to the Forefront Brings Measurable Results
Quality initiatives are imperative in the pharmaceutical industry, but not all quality systems are equal.
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Making Strides: Biologics Push Forward
Biologics are no longer seen as the ‘next big thing’ in drug development; they are now a mainstay in many pipelines.
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Clinical Trials Find a Device for Growth
Technology developments and a growing population are driving growth in the clinical trials market.
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The Search for Alternative Delivery Methods Continues
While biologic drugs offer numerous advantages, the need to administer them parenterally is a significant limitation.
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Biopharmaceutical Manufacturing Goes Mainstream
With biologics, the maxim is “process is the product,” and suppliers are meeting the technologies demanded by developers with an equal amount of innovation.
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From Blobs to Hearts: Understanding the 3D Bioprinting Revolution
Additive manufacturing (AM), commonly referred to as ‘3D printing,’ is a revolutionary technology that seems to bleed across disciplines.
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Optimizing API Production as a True Manufacturing Partner
The required attributes of a good API — namely quality, safety and effectiveness — stem from good manufacturing processes.
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Small Molecule Injectable Manufacturing: Challenges and Complexities
Despite the growth of biologic drugs, medicines based on small molecules remain important in the treatment of all types of diseases.
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Building a One-Stop Shop CDMO for Biopharmaceuticals
There are few true one-stop shop organizations providing support to pharma companies developing biosimilars and branded biologics.
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The People’s Choice: Premeasured Single Dosage Forms
Taking medication as intended is an issue for many patients — single unit packaging is a solution for better FDA and patient compliance.
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Design of Complex Biopharmaceutical Facilities: Considering Options and Alternatives
The movement of next-generation drug products toward commercialization is driving the need for new and different technologies and facilities.
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Designing Flexibility for Added Value
Biopharmaceutical facilities today rely on a wide range of equipment and processes that require a high level of flexibility.
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Fit Biopharmaceutical Facilities: A Predictive Maintenance Approach
It is essential that both mature and newer existing facilities manage the aging process.
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Nice Symposium Oral Solid Dose 2017: Bringing the Supply Chain Together to Tackle Development Challenges
The first-ever “Nice Symposium,” hosted by That’s Nice, brought together a diverse range of service and technology providers and their customers.
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Q: If You Could Have One Piece of Biologic Manufacturing Equipment Improved, What Would It Be and Why?
Improving bioreactor and cell retention setup used in perfusion processes could be a major improvement area for biologic manufacturers.
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Q: How is Growth in the Biosimilars Market Impacting the Development of New Biologics Manufacturing Equipment Technologies?
Biosimilar market growth is heightening the pressure to improve cost and quality.
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Q: Has Downstream Processing Technology Caught up with the Significantly Higher Titers Coming Out of the Current Upstream Process? If No, What Issues Remain?
Yes, downstream technology development is advancing to accommodate higher titers via multiple chromatography approaches.
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Q: What is the Most Significant Recent Advancement in Downstream Bioprocessing Technology? Why is it so Important?
Recent advancements in continuous chromatography and SPTFF are all contributing to significant improvements across the complete process.
PAP-Q1-17-RT-002
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Propagating a Full Spectrum of Services for ADC Development and Manufacture
John Manzello and Campbell Bunce from Abzena explain the need for CDMOs to provide services for antibody-drug conjugates.
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What’s New in Bioanalysis?
Chad Briscoe, Executive Director at PRA Health Sciences discusses developments in small and large molecule bioanalysis, including LC-MS-MS.
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FDA Fast Track Designation Granted for Pfizer and Eli Lilly’s Innovative Pain Treatment
Tanezumab is currently in global Phase III trials for chronic pain.
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3D Patch Reduces Ischemia in Mouse Models
The architecture of the patch organizes cells to enhance blood flow.
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Sanofi Will Increase Investments in Biologics
The French firm is positioned to be on the forefront of this crucial market category and will spend 600 million euros to increase capacity.
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Early-Stage Planning for End-Stage Success
Icagen, Inc. accelerates the identification of high quality drug candidates through advanced computation and process automation.
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Checkmate Pharmaceuticals Receives Series B Funding for CMP-001
The company will use $27 million for Phase Ib clinical trials of the immuno-oncology therapy.
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Creating Differentiated Value for Biotechs
Alcami is expanding their U.S. parenteral manufacturing footprint while leveraging pre-filled syringe capability.
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Making Your Facility a Future Facility
CRB is designing scalable processes through the FutureFacility™ concept and addressing long-term challenges.
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MicroJet Reactor (MJR) for APIs
Michelle Hall, Marketing Director at CoreRx talks about the company’s new nanotechnology.
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Latest
View All LatestNumber of New Collaborations Announced by Johnson & Johnson Innovation
Jun 23, 2017 11:37:07 AM PAO-M06-17-NI-014Upsher-Smith Laboratories’ Generics Business Now Part of Sawai Pharmaceutical
Jun 23, 2017 11:36:32 AM PAO-M06-17-NI-016Biosimilar Manufacturers Get Favorable Decision from US Supreme Court
Jun 23, 2017 11:36:04 AM PAO-M06-17-NI-017Harvard University Researchers Develop Ultrasound/Nanoparticle Method for Targeted Delivery of Chemotherapeutics
Jun 23, 2017 11:35:34 AM PAO-M06-17-NI-015Checkmate Pharmaceuticals Receives Series B Funding for CMP-001
Jun 20, 2017 12:38:04 PM PAO-M06-17-NI-013FDA Fast Track Designation Granted for Pfizer and Eli Lilly’s Innovative Pain Treatment
Jun 20, 2017 12:35:54 PM PAO-M06-17-NI-010The Impact of Wearable Health Monitoring Tools on Contract Research Organizations (CROs)
Jun 20, 2017 12:02:17 PM CPM-M04-17-NI-001Takeda Begins Expansion of its Manufacturing Footprint in Ireland
Jun 16, 2017 3:13:08 PM PAO-M06-17-NI-009Eli Lilly, KeyBioscience Agree to Work on the Development of New Diabetes Drugs
Jun 16, 2017 3:09:42 PM PAO-M06-17-NI-011US Diabetes Patients Now Have Access to an “Artificial Pancreas” for Automatic Insulin Delivery
Jun 16, 2017 3:09:07 PM PAO-M06-17-NI-012Vetter and Microdermics Will Develop Microneedle Delivery Systems
Jun 13, 2017 5:22:35 PM PAO-M06-17-NI-008Topics
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Building a One-Stop Shop CDMO for Biopharmaceuticals
PAP-Q2-17-CL-012
Designing Flexibility for Added Value
PAP-Q2-17-CL-015
The People’s Choice: Premeasured Single Dosage Forms
PAP-Q2-17-CL-014
Columns
Making Real-Time Process Analytical Technology In Biomanufacturing a Reality
