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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.
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Icagen on the Road to BIO: Early-Stage Planning for End-Stage Success
Kenneth F. Wertman Ph.D., Senior Vice President at Icagen, Inc. discusses the cycle of discovery on the Road to BIO.
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Unither Pharmaceuticals on the Road to BIO: Innovation in Delivery
David Kudla, General Manager for North America at Unither Pharmaceuticals, discusses blow-fill-seal and powder stick-pack technology.
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Upsher-Smith Laboratories’ Generics Business Now Part of Sawai Pharmaceutical
The acquisition broadens Sawai's generics footprint in the US.
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Harvard University Researchers Develop Ultrasound/Nanoparticle Method for Targeted Delivery of Chemotherapeutics
New drug delivery platform reduces the systemic toxicity associated with conventional chemotherapy.
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Making Real-Time Process Analytical Technology In Biomanufacturing A Reality
Clint Pepper, Ph.D., Director of MAST Technology at Capsugel, explains the Modular Automated Sampling Technology platform.
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Biosimilar Manufacturers Get Favorable Decision from US Supreme Court
Notification of intent to market a biosimilar can be made prior to FDA approval.
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Number of New Collaborations Announced by Johnson & Johnson Innovation
The company is focused on developing treatments for obesity, diabetes, non-alcoholic steatohepatitis (NASH) and rheumatoid arthritis.
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The Impact of Wearable Health Monitoring Tools on Contract Research Organizations (CROs)
In no other industry does the latest technology have the ability to impact lives more directly than in pharma.
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Accelerating Discovery to Improve Lives
Bio-Rad offers a complete library of antibody solutions, with over 11,000 antibodies and related reagents for immunology and cancer research.
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Trends In Excipient Demand
Excipients play a key role in helping pharmaceutical manufacturers serve patients better through improved compliance and efficacy of treatment.
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The Road To BIO: An Epic Jouney
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Pharma's Almanac TV
View All VideoIcagen on the Road to BIO: Early-Stage Planning for End-Stage Success
Kenneth F. Wertman Ph.D., Senior Vice President, Icagen. View more about Icagen on the Road to BIO.
Unither Pharmaceuticals on the Road to BIO: Innovation in Delivery
David Kudla, General Manager for North America, Unither Pharmaceuticals. View more about Unither Pharmaceuticals on the Road to BIO.
Bio-Rad on the Road to BIO: Accelerating Discovery to Improve Lives
Steven Blakely, Global Director of Marketing, Drug Discovery & Development Business, Bio-Rad. View more about Bio-Rad on the Road to BIO.
CRB on the Road to BIO: Making Your Facility a Future Facility
Matthew Kennedy, Process Specialist, Senior Associate, CRB. View more about CRB on the Road to BIO.
Latest
View All LatestFDA’s Gottlieb Weighs in on the Drug Quality and Security Act (DQSA)
Jun 27, 2017 4:24:44 PM PAO-M06-17-NI-018Recombinant Flu Vaccine Outperforms Egg-based Alternatives
Jun 27, 2017 4:18:39 PM PAO-M06-17-NI-019Number 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
