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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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Corporate Social Responsibility as a Driver for Improved Sustainability
Allain de Wilde, Corporate Social Responsibility Director and Loïc Allanos, Corporate Social Responsibility Manager for Servier Group, describe the how the industry can meet CSR standards.
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Modern OSD Facility Design Considerations for Operational Efficiency and Regulatory Compliance
When engineering and designing today’s OSD manufacturing facilities, the primary goal is to develop an operation that provides for the highest levels of product quality and operational efficiency, says Dave DiProspero, Associate/Director of Pharmaceutical Process Technology at CRB USA.
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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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Achieving Controlled Nucleation During Aseptic Lyophilization
Controlled nucleation is essential for obtaining high-quality lyophilized products with intra- and inter-batch consistency, says Robert Darrington, VP, Technical Marketing, SP Industries, Inc.
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Experience Meets Flexibility
Terry Novak, Chief Operating Officer for Tedor Pharma discusses how to meet demands of an increasingly complex global OSD market
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State-of-the-Art Biologics Manufacturing in an Unexpected Location
Vladas Algirdas Bumelis, Chief Executive Officer and Chairman of the Board for Biotechpharma comments on how the company, located in Lithuania is exporting biologic drug substances worldwide.
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WuXi STA First CDMO to Support the Approval of an Innovative Drug in China Through the "MAH" Pilot
WuXi STA enables Ascletis to receive NDA Approval from China FDA for Ganovo (R).
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The US FDA Approves First Supplemental Abbreviated New Drug Application (sANDA) for Glenmark Pharmaceuticals' Manufacturing Facility in Monroe, North Carolina
The approval covers: Atovaquone and Proguanil Hydrochloride Tablets, 250 MG/100 MG and 62.5 MG/25 MG, a generic version of GlaxoSmithKline's Malarone® (atovaquone and proguanil hydrochloride) Tablets.
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China Grants First Approval for PD-1/L1 Checkpoint Inhibitor
The China Drug Administration approved Bristol-Myers Opdivo as a 2nd line treatment for patients with locally advanced or metastatic non-small-cell lung cancer (NSCLC).
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Could a Bispecific Antibody Be A Functional Cure for AIDS?
Hong Kong University researcher Chen Zhiwei reports successful results in mouse models.
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HPAPI’s and Two-Piece Liquid-Fill Capsules: The Perfect Match
For oral solid dosage (OSD) drugs, formulating highly potent APIs as liquids in hard-shell capsules provides significant advantages over OSD forms, including soft-shell capsules, explains Tom Breshamer, Operations Manager for CapsCanada.
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WuXi Laboratory Testing Division: Propelling Innovation and Better Treatments for Patients
Jason Liu, Ph.D., MBA, SVP of WuXi AppTec and COO of Laboratory Testing Division and Francis L. Tse, Ph.D., VP of WuXi AppTec and CSO / Head of US Sites of the Laboratory Testing Division describe how WuXi AppTec’s Laboratory Testing Division (LTD) has expanded its global footprint.
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Successful Solid Dose Equipment Training
Helping operators become technicians and building strong production teams requires training on machine set up, operation, cleaning, and maintenance, explains Mike Tousey, Technical Director/CEO of Techceuticals.
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Transforming A CDMO Using an Operational Excellence Approach
Sébastien Mathieu, Industry Performance Deputy Director and Laurent Dray, Industry Performance Leader for Servier CDMO explain how to improve productivity and efficiency, reduce costs and environmental impacts and enhance quality assurance through operational excellence.
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Small Molecule Injectable Manufacturing: Challenges and Complexities
Marga Viñes, Business Development Manager for Grifols, explains concentrated and diluted small molecule parenteral formulation options.
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Flexible, Mobile, Modular: High-Containment Viral Vector Center of Excellence
Next-generation viral vector and gene therapy manufacturing facilities must be flexible, says Thomas Page, Ph.D., Vice President of Engineering and Asset Development for Fujifilm Diosynth Biotechnologies.
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Will Rapid Genome Sequencing Become A Standard Practice for Acutely Ill Infants?
Rapid whole genome sequencing has the potential to save lives and prevent permanent brain and organ damage in infants.
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French Pharma Company Ipsen Moves US Headquarters from New Jersey to Boston
Firm will join its manufacturing and R&D sites in the East Kendall area.
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StrideBio Closes $15.7 Million Series A Financing to Advance Transformational AAV Platform
The financing was led by Hatteras Venture Partners. Co-investors include Takeda Ventures, Inc., UCB Ventures, and Alexandria Venture Investments, LLC.
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BridgeBio Pharma Launches CoA Therapeutics to Target Coenzyme-A for Rare Genetic Disorders
CoA Therapeutics' lead compound will be entering the clinic in 2019 with a planned initial focus on pantothenate kinase-associated neurodegeneration, or PKAN.
THE ROAD TO BIO: THE EXTENDED STORY
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The Road to BIO in Review
The Road To BIO: Day 12 California
The Road To BIO: Day 11 Arizona /// California
The Road To BIO: Day 10 Texas /// Arizona
The Road To BIO: Day 9 Texas
The Road To BIO: Day 8 Texas
The Road To BIO: Day 7 Mississippi /// Texas
The Road To BIO: Day 6 Georgia /// Mississippi
The Road To BIO: Day 5 South Carolina /// Georgia
The Road To BIO: Day 4 Tennessee /// South Carolina
The Road To BIO: Day 3 Pennsylvania /// Tennessee
The Road To BIO: Day 2 New York /// Pennsylvania
The full story of this epic journey can be experienced as an audiobook. Listen to the story behind the story – the characters, the challenges, and all 12 days of the Road To BIO.
Nice Insight Awareness/Perception Scorecard
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Latest
View All LatestCould a Bispecific Antibody Be A Functional Cure for AIDS?
Jun 19, 2018 1:14:03 PM PAO-M06-18-NI-015China Grants First Approval for PD-1/L1 Checkpoint Inhibitor
Jun 19, 2018 1:11:20 PM PAO-M06-18-NI-014French Pharma Company Ipsen Moves US Headquarters from New Jersey to Boston
Jun 15, 2018 1:00:09 PM PAO-M06-18-NI-013Will Rapid Genome Sequencing Become A Standard Practice for Acutely Ill Infants?
Jun 15, 2018 12:53:46 PM PAO-M06-18-NI-012HPAPI’s and Two-Piece Liquid-Fill Capsules: The Perfect Match
Jun 14, 2018 3:42:01 PM PAO-06-18-CL-001Hormone Therapy Appears to Be the Best Bet for Treating Early Breast Cancer
Jun 14, 2018 1:00:03 PM PAO-M06-18-NI-011Pfizer Expands Investment in Biotech through Pfizer Ventures
Jun 14, 2018 12:55:15 PM PAO-M06-18-NI-010FDA Approves Venclexta/Rituxan Combination Treatment for Leukemia
Jun 12, 2018 2:35:44 PM PAO-M06-18-NI-009Preliminary Data Suggests DENKI Pain Blockers Don’t Have Abuse Potential
Jun 12, 2018 2:29:55 PM PAO-M06-18-NI-008Funding Round Will Boost Efforts to Develop Antibiotic for Alzheimer’s Disease
Jun 5, 2018 2:11:05 PM PAO-M06-18-NI-005
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