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Building a Biologics Business from the Ground Up
Building a biologics business from the ground up provides tremendous flexibility but requires the right business strategy.
PAP-Q2-18-CL-008 -
Leveraging Hot Melt Extrusion for Solubility and Continuous Manufacturing
Hot melt extrusion (HME) technology leads to enhanced solubility.
PAP-Q2-18-CL-007 -
Inside Mergers & Acquisitions
Innovation and efficiency are both key to successful drug development and commercialization.
PAP-Q2-18-CL-001 -
Changes in the Biopharma Industry: from Minor to Major Evolution
The biopharmaceutical industry continues to grow rapidly. Targeted biologics are helping treat previously untreatable diseases.
PAP-Q2-18-NI-002 -
Supporting Patient-Centric Clinical Trials from Point-of-Origin through the Last Mile
The clinical trial paradigm has shifted.
PAP-Q2-18-CL-002 -
Taking Middle-Market CROs and CDMOs to the Next Level
Smaller outsourcing organizations often need assistance moving to the next level.
PAP-Q2-18-CL-003 -
Addressing Development Challenges for Complex Biologic Drug Candidates
Biotherapeutics identified as potential drug candidates are increasingly complex.
PAP-Q2-18-CL-004 -
Flexible, Mobile, Modular: High-Containment Viral Vector Center of Excellence
Next-generation viral vector and gene therapy manufacturing facilities must be flexible.
PAP-Q2-18-CL-005 -
Meeting Biopharma Contract Manufacturing Needs with a Flexible Global Network
As biologic drugs become more complex and sophisticated, biopharmaceutical companies increasingly need the support of contract development and manufacturing organizations (CDMOs) with advanced capabilities and technology platforms that are consistently implemented across scales and geographies.
PAP-Q2-18-CL-006 -
Using a Risk-Based Approach to Manufacturing in a Multi-Product Facility
Manufacturing in multi-product facilities affords numerous advantages- and challenges.
PAP-Q2-18-CL-009 -
State-of-the-Art Biologics Manufacturing in an Unexpected Location
Biotechpharma UAB, located in Vilnius, is exporting biologic drug substances worldwide.
PAP-Q2-18-CL-010 -
Overcoming Raw Material and Supply Chain Challenges in Viral Vector Manufacturing
Viral vector manufacturers involved in all stages of clinical-trial-material and commercial product production rely on single-use (SU) technologies.
PAP-Q2-18-CL-011 -
Modern OSD Facility Design Considerations for Operational Efficiency and Regulatory Compliance
Oral solid dosage (OSD) remains the preferred dosage delivery form for the formulation of many of today’s drug products.
PAP-Q2-18-CL-012 -
Strengthening the Outsource Service Offering through Integration
Controlling costs and increasing efficiencies are two fundamental drivers for outsourcing of pharmaceutical manufacturing.
PAP-Q2-18-CL-013 -
Corporate Social Responsibility as a Driver for Improved Sustainability
The pharmaceutical industry must respond to growing expectations regarding the environmental impact of medicinal products and manufacturing.
PAP-Q2-18-CL-014 -
Challenges for Next-Generation Biological Therapeutics Discovery and Development
In the last three and half decades, the focus of drug discovery and development has gradually shifted to large, complex molecular entities — therapeutic biologics.
PAP-Q2-18-FA-001 -
Thinking a Generation Ahead: Biologics-Based Therapy
Whether dealing with stem cells, CRISPR Cas-9 technology or antibody-drug conjugates, there is no shortage of innovation - the challenge is scaling up.
PAP-Q2-18-FA-002 -
Finishing Touches – The Future of Fill-Finish and Pharma Packaging
Fill-finish has remained relatively stable in spite of myriad developments in the industry over the last decade.
PAP-Q2-18-FA-003 -
Maximizing ROI through Equipment Liquidation
Cost pressures are significant drivers for pharmaceutical manufacturers seeking to eliminate redundancies and increase productivity and efficiency.
PAP-Q2-18-CL-015 -
Experience Meets Flexibility
Advances in rapid synthesis technologies are leading to the preparation of new classes of compounds with attractive therapeutic properties.
PAP-Q2-18-CL-016 -
Scientific Expertise Facilitates Oral Peptide Product Development and Manufacturing
Most often developed as injectable formulations, a few “oral peptide” drugs have been approved in recent years.
PAP-Q2-18-CL-017 -
Achieving Controlled Nucleation During Aseptic Lyophilization
Controlled nucleation is essential for obtaining high-quality lyophilized products with intra- and inter-batch consistency.
PAP-Q2-18-CL-018 -
BioPharma CDMO Success Requires Technical Leadership and Problem-Solving Capabilities
Since their introduction, biologic drugs have shown great potential to treat diseases not possible to remedy with traditional small-molecule drugs.
PAP-Q2-18-CL-019 -
Providing Flexible Capabilities to Meet Market Demand for Sterile Fill-Finish Services
The fill-finish step in the manufacturing of drugs is the last step completed before a product is packaged and delivered to the patient.
PAP-Q2-18-CL-020 -
DOPING – Famous Cases, Substances and Values in Sports
Doping remains a constant threat to the ethics and values in professional sports, as well as on the amateur level.
PAP-Q2-18-NI-003
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Investing in New Technologies for Innovative Functional Solutions
Sarath Chandar, Chief Scientific Officer, Applied Innovation Group at SPI Pharma discusses how the company is re-engaging in innovation.
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Particle Engineering for Improved Bioavailability in Oral Solid Dose Medications
Catalent’s Ronak Savla, Ph.D., Scientific Affairs Manager and Stephen Tindal, Director of Scientific Affairs, explains the OSD evolution.
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How do you Address Operational Excellence as an Institution?
Industry experts weigh in on our Roundtable question.
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Fit Biopharmaceutical Facilities: A Predictive Maintenance Approach
Andrew Harris, Associate, Lead Process Engineer and Joe Povenski, Process Specialist for CRB USA explain maintaining facilities.
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Optimizing API Production as a True Manufacturing Partner
Jim Scandura, Executive Vice President, Chief Operating Officer at Avara Pharmaceutical Service discusses serving as a partner for API production.
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Analytical Testing - Contractors Take on the Challenge of Complex Molecules
A SPECIAL FEATURE by Drug Development & Delivery.
The global pharmaceutical analytical testing outsourcing market could reach $9.6 billion by 2025.
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Stem Cell Research May Lead to Treatments for Gastrointestinal Diseases
Researchers have grown a mini esophagus from stem cells.
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Gene that Helps Cells Resist Zika Infection Identified
Found by University of Texas Southwestern Medical Center researchers using CRISPR.
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Researchers Make Major Breakthrough in Controlling the 3D Structure of Molecules
A team of scientists from The Graduate Center of The City University of New York has made a breakthrough in chemical synthesis that makes it possible to quickly and reliably modify a molecule's 3D structure.
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FDA Permits Marketing of Transcranial Magnetic Stimulation for Treatment of Obsessive Compulsive Disorder
Transcranial magnetic stimulation (TMS) is a procedure that uses magnetic fields to stimulate nerve cells in the brain.
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Accelerating Approval and Reducing Costs of Spray Dried Drugs through Development by Design (DbD)
Filipe Gaspar, Vice President, R&D and Márcio Temtem, Ph.D., Associate Director for Particle Design & Formulation at Hovione explain Development by Design (DbD).
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Achieving a High Level of Customer Service Through Lean Quality Management
Warren Horton, Executive Vice President Global Quality Assurance and Regulatory at Avara Pharmaceutical Services discusses the real foundation of customer service.
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Differentiating Generic SODFs with Hard Capsule Formulations
With lower development costs and greater flexibility, hard capsules are the best choice for the formulation of generic solid oral dosage pharmaceuticals, explains Jonathan Gilinski, Executive Director for CapsCanada.
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Innovating Equipment: Inline Buffer Dilution Technology
Nice Insight is in conversation with Kimo Sanderson, at Asahi Kasei Bioprocess America, to discuss the company’s “technology of the decade.”
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Implications of Serialization for the U.S. Pharma Industry
Lee Murtagh and Walter Hoberg III of Alcami explain the upcoming regulatory impact on the industry.
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Perspectives on Product Pricing Strategy and Practice
Getting pricing “right” is a tricky balancing act, but one that offers tremendous value for all.
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Elysium Health™ Announces Exclusive License for Use of Nicotinamide Riboside for the Slowing of Aging and Prevention of Age-Related Diseases from Mayo Clinic and Harvard
Aging is the single greatest risk factor for major debilitating and life-threatening conditions, including cancer, cardiovascular disease, and neurodegeneration.
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Patients with Rare Leukemia Disease Will Have New Treatment Option
US FDA approves AstraZeneca’s Lumoxiti (moxetumomab pasudotox) for the treatment of patients with hairy cell leukemia (HCL) who have undergone at least two prior therapies.
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New Genetic Understanding Could Lead to Brain Cancer Treatments
Researchers have identified the gene mutation that leads to the brain cancer glioblastoma
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Xeris Pharmaceuticals and OHSU Conducting Artificial Pancreas Clinical Trial Using Xeris’ Novel Ready-to-Use Liquid Glucagon
Patients enrolling in Phase 1 clinical trial using Xeris’ ready-to-use liquid glucagon formulation as part of a fully integrated, dual-hormone closed-loop system.
Nice Insight Awareness/Perception Scorecard
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Latest
View All LatestFish-Oil Drug Shows Dramatic Results in Cardiovascular Study
Sep 25, 2018 12:56:50 PM PAO-M09-18-NI-025FDA Removes Partial Clinical Hold on Tazemetostat Clinical Trials
Sep 25, 2018 12:53:57 PM PAO-M09-18-NI-024New Evidence Suggests the Brain and Stomach are in Direct Communication
Sep 25, 2018 12:49:56 PM PAO-M09-18-NI-023New Small-Molecule Drugs Could Enhance Immune Responses to Cancer
Sep 25, 2018 12:35:33 PM PAO-M09-18-NI-020Stem Cell Research May Lead to Treatments for Gastrointestinal Diseases
Sep 25, 2018 12:32:08 PM PAO-M09-18-NI-019New Genetic Understanding Could Lead to Brain Cancer Treatments
Sep 21, 2018 10:59:39 AM PAO-M09-18-NI-017Patients with Rare Leukemia Disease Will Have New Treatment Option
Sep 21, 2018 10:57:13 AM PAO-M09-18-NI-016Allergan Makes Neurotoxin Buy with Acquisition of Bonti Inc.
Sep 19, 2018 4:15:43 PM PAO-M09-18-NI-015Transforming with an Equipment Partner: Preparing the Industry for Serialization
Sep 17, 2018 6:00:00 AM PAO-M09-18-CL-001Ophthalmic Drug Developer Kodiak BioSciences Files for IPO
Sep 14, 2018 1:15:11 PM PAO-M09-18-NI-010EU Gives Nod to KEYTRUDA and Chemotherapy Combination Treatment
Sep 14, 2018 1:12:10 PM PAO-M09-18-NI-009Sanofi-Aventis Collaborates with Dyadic International on Cl Gene Expression
Sep 13, 2018 2:34:36 PM PAO-M09-18-NI-007
TOPICS
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Researchers Make Major Breakthrough in Controlling the 3D Structure of Molecules
Sep 25, 2018 5:00:00 AM -
Safety Risks Associated with Crushing or Altering Medication
Sep 25, 2018 5:00:00 AM -
GenomeDx Achieves Significant Medicare Milestone for Decipher Prostate Biopsy Genomic Classifier
Sep 25, 2018 5:00:00 AM -
Synthetic Biology Making Strides in Key Applications, Finds IDTechEx
Sep 25, 2018 5:00:00 AM
Nice Insight Industry Benchmark Reports 2017
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