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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 -
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 -
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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Strengthening the Outsource Service Offering through Integration
Controlling costs and increasing efficiencies are two fundamental drivers for outsourcing of pharmaceutical manufacturing, explains Luigi Trussardo, CEO of Olon Ricerca Bioscience.
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Meeting Biopharma Contract Manufacturing Needs with a Flexible Global Network
Gustavo Mahler, President & CEO of AGC Biologics discusses the increasing need for CDMO support to provide with advanced capabilities and technology platforms across scales and geographies.
President & CEOAGC Biologics -
Creating Comprehensive Solutions through Laboratory Testing
Xin Zhang, Ph.D., Vice President & Global Head of DMPK, Bioanalysis & Abgent, Eugene Gong, Ph.D., Vice President, Head of Technology Operations & Analytical & Regulatory CMC and Ed Amat, Vice President of International Sales & Marketing for WuXi AppTec discuss the company’s Laboratory Testing Division.
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Addressing Development Challenges for Complex Biologic Drug Candidates
Karen Fallen, Vice President, Business Unit Head of Clinical Development & Manufacturing at Lonza, discusses how to handle increasingly complex biological candidates.
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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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An OEE Approach To Solid Dose Equipment Purchasing and Implementation
Adam Covitt, Vice President of Federal Equipment Company discusses strategic equipment acquisition.
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Groundbreaking for Amgen in Rhode Island
The $200-million biopharma plant will be completed in 2020.
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Quethera Acquired by Astellas Pharma
Astellas will pay up to £85m in upfront and contingent payments.
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Allergan and Editas Medicine Announce Exercise of Options to Jointly Develop CRISPR Genome Editing Experimental Medicine EDIT-101
EDIT-101 is Editas Medicine's experimental CRISPR genome editing medicine for the treatment of Leber Congenital Amaurosis type 10 (LCA10).
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Pliant Therapeutics Receives FDA Orphan Drug Designation for Lead Program PLN-74809 in Idiopathic Pulmonary Fibrosis
Pliant Therapeutics, Inc., a biotechnology company focused on discovering, developing and commercializing treatments for fibrotic diseases, has been granted orphan drug designation for its anti-fibrotic lead compound, PLN-74809, for the treatment of idiopathic pulmonary fibrosis (IPF).
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Building a Robust Supply Chain with Dependable Quality Primary Suppliers
Drug manufacturers and their suppliers face a number of challenges, such as downward pricing pressures and the need for flexibility and speed to market, says Dale Martin, General Manager & CFO for CapsCanada.
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With Expertise Comes Security
Using a trusted expert to remove surplus equipment helps protect your facility and assets, says Matt Hicks, Chief Operating Officer & Counsel for Federal Equipment Company.
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Death to Cleanrooms in Biopharmaceutical Manufacturing
Marc Pelletier, Ph.D., Director of CRB USA explains the benefits of closed processing.
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Biosimilars: Are We on the Edge of a New Era of Biologics?
Experts weigh in on our Roundtable question.
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Nice Insight Overview: The Key to Pharma’s Next Generation Success
Evolving markets are prompting drug owners and developers to pursue new business models in the post-blockbuster era.
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Behind the Scenes of International Pharmaceutical Business Success: A Conversation with Horst Wallrabe
Haig Armaghanian is in conversation with Horst Wallrabe, formerly of Bayer, to reflect on his impressive career and what lies ahead.
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Grifols Achieves Key Milestone with FDA Approval of the New Consolidated Manufacturing Facility (CMF) for Production of Recombinant Proteins
The company received approval to relocate existing immunodiagnostic manufacturing operations to a new Consolidated Manufacturing Facility (CMF) in Emeryville, California.
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Xolair Gets Breakthrough Therapy Designation from US FDA for Treatment of Food Allergies
If approved, the drug would be the first FDA-approved treatment for the prevention of severe reactions due to food allergies.
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Perrigo to Divest Its Prescription Drug Business
Company to focus on generics and consumer products.
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Array BioPharma Receives FDA Breakthrough Therapy Designation for BRAFTOVI™ in combination with MEKTOVI® and cetuximab for BRAFV600E-mutant Metastatic Colorectal Cancer
The designation is based on Phase 3 BEACON CRC safety lead-in data.
Nice Insight Awareness/Perception Scorecard
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Aug 14, 2018 12:13:08 PM PAO-M08-18-NI-016Forces Driving Growth in the U.S. Surgical Microscopes Market
Aug 9, 2018 3:58:58 PM PAO-08-18-CL-001Intertek Groups Expands Offerings with the Acquisition of Alchemy Systems
Aug 9, 2018 1:12:27 PM PAO-M08-18-NI-012New Method Developed for Stereoselective Synthesis of Biologic Drug Substances
Aug 8, 2018 2:11:08 PM PAO-M08-18-NI-011New Collaboration Targets Drug Development Using the Gut Microbiome
Aug 7, 2018 3:12:17 PM PAO-M08-18-NI-007
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Nice Insight Industry Benchmark Reports 2017
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