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Biologics – Large Molecule

126 Articles available
FDA Clearance

Inova Diagnostics Receives FDA Clearance for Test to Detect Antibodies to HMGCR

PR-M09-18-NI-031
Clinical Trial

BeiGene Initiates New Phase 3 Trial of Anti-PD-1 Antibody Tislelizumab Combined with Chemotherapy as First-line Treatment for Patients with Advanced Squamous Non-Small Cell Lung Cancer in China

PR-M08-18-NI-115
Small Molecule

SwRI to host 2018 small molecule drug development workshop

PR-M08-18-NI-112
FDA Approval

Kyowa Kirin Announces FDA Approval of Poteligeo® (mogamulizumab-kpkc) for the Treatment of Mycosis Fungoides and Sézary Syndrome

PR-M08-18-NI-109
Biologics

Building a Biologics Business from the Ground Up

PAP-Q2-18-CL-008
FDA Approval

Grifols Achieves Key Milestone with FDA Approval of the New Consolidated Manufacturing Facility (CMF) for Production of Recombinant Proteins

PR-M08-18-NI-123
Biologics

New Method Developed for Stereoselective Synthesis of Biologic Drug Substances

PAO-M08-18-NI-011
Biosimilars

Another mAb Biosimilar on the Horizon in Europe

PAO-M06-18-NI-006
Biologic Candidates

Addressing Development Challenges for Complex Biologic Drug Candidates

PAP-Q2-18-CL-004
Contract Manufacturing Needs

Meeting Biopharma Contract Manufacturing Needs with a Flexible  Global Network

PAP-Q2-18-CL-006
Multi-Product Facility Manufacturing

Using a Risk-Based Approach to Manufacturing in a Multi-Product Facility

PAP-Q2-18-CL-009
Controlled Nucleation

Achieving Controlled Nucleation During Aseptic Lyophilization

PAP-Q2-18-CL-018
Market Expansion

BioPharma CDMO Success Requires Technical Leadership and Problem-Solving Capabilities

PAP-Q2-18-CL-019
FDA Approval

FDA Approves New Migraine Treatment

PAO-M05-18-NI-014
FDA

AbbVie Submits Biologics License Application to U.S. FDA for Investigational Treatment Risankizumab for Moderate to Severe Plaque Psoriasis

PR-M04-18-NI-103
Biologics

Thermo Fisher Scientific Announces $50 Million Investment to Enhance Biologics Capabilities

PR-M04-18-NI-90
Strategic Partnership

Charles River Laboratories and PathoQuest Expand Strategic Biologics Partnership

PR-M04-18-NI-39
Expanded Capacity

AGC Biologics Increases Footprint in Bothell, WA

PR-M04-18-NI-016
Biologics License Application

FDA Accepts for Filing Supplemental Biologics License Application (sBLA) for Xeomin® (incobotulinumtoxinA) in Adult Patients with Sialorrhea

PR-M03-18-NI-062
Biologics

Charles River Laboratories Makes Expansions to Global Biologics Infrastructure

PR-M03-18-NI-044
Fill/Finish

Getting to the Finish Line

PAP-Q1-18-NI-004
Biologics

Fully Supporting Customer Needs for Biologics Development and Manufacturing

PAP-Q1-18-CL-016
Biologics

Next Generation Biologics, Janssen's Tremfya, Eli Lilly's Taltz, and Novartis' Cosentyx, Raising the Bar in Psoriasis Management

PR-M03-18-NI-040
License Agreement

Xencor Signs Four Commercial License Agreements with Selexis SA to Advance its Pipeline of XmAb Bispecific Antibody Drug Candidates

PR-M03-18-NI-009
Facility

First Order Reported for New Samsung Plant

PAO-M03-18-NI-001
Facility

Cytovance® Biologics, Inc. announces completion of first batch in new state-of-the-art 1000L microbial facility

PR-M02-18-NI-68
Stem Cell

Royal Biologics Launches Amnio-Maxx™, a Stem Cell Product Derived From Human Amniotic Placental Tissue

PR-M02-18-NI-045
Biomanufacturing

Amgen to Open Biomanufacturing Plant in the US

PAO-M02-18-NI-010
IND Application

WuXi Biologics Congratulates BioAtla on FDA Clearance of IND Application for CAB-AXL-ADC

PR-M02-18-NI-011
Supplier

Abzena Selects Sartorius Stedum Biotech as Supplier of Single-Use Tech

PAO-M01-18-NI-033
Merger

CMC Biologics Becomes AGC Biologics

PAO-M01-18-NI-032
Biologics

EU Approves AstraZeneca’s Respiratory Biologic

PAO-M01-18-NI-031
Biologics

New Class of Exosome Biologics Focuses on Stroke Treatment

PAO-M01-18-NI-011
Business

Cue Biopharma Announces Closing of Initial Public Offering

PR-M01-18-NI-003
FDA Guidance

FDA Received Numerous Comments on Its Draft Guidance for Evaluating Biosimilarity

PAO-M01-18-NI-004
Biosimilars

Pfizer Receives FDA Approval for Remicade® Biosimilar

PAO-M12-17-NI-039
Added Capacity

World’s Largest Biologics Plant Gets EMA Nod

PAO-M12-17-NI-029
Immuno-oncology

Genentech and Biothera to Assess Combination Cancer Therapy

PAO-M12-17-NI-010
Biosimilars

First Biosimilar to Treat Breast and Stomach Cancers Approved

PAO-M12-17-NI-007
Biosimilars

Boehringer Ingelheim’s Adalimumab Biosimilar Wins First EU Approval

PAO-M11-17-NI-045
Biologics

Collaboration Announced Between Takeda Pharmaceutical and Portal Instruments

PAO-M11-17-NI-035
Drug Development

Compugen Advances Lead Anti-TIGIT Monoclonal Antibody to Manufacturing

PAO-M11-17-NI-025
Business

Grand River Aseptic Manufacturing Announces Majority Investment by Arlington Capital Partners

PR-M11-17-NI-014
CAR T

Mustang Bio Sends CAR T Cell Therapy Line to College

PAO-M11-17-NI-003
Biologics

ADCs: The Future of Biologic Drugs

PAP-Q04-17-VP-001
Innovation

Moving Beyond Monoclonal Antibodies

PAP-Q4-17-FA-002
Innovation

Single-Use Operational Excellence Explained: Effective Lifecycle Management

PAP-Q4-17-CL-006
Cell Line Development

Abzena and UGA Team Up to Develop MS Therapeutic

PAO-M10-17-NI-033
Funding

Ventria Bioscience aids global fight against intestinal infections that threaten up to 400 million children a year

PR-M10-17-NI-008
Biosimilars

Amgen To Co-Develop Biosimilars for Chinese Market with Simcere Pharmaceutical Group

PAO-M10-17-NI-007
Biosimilar

FDA Approves First Biosimilar Treatment for Multiple Cancers

PAO-M09-17-NI-030
Acquisition

Catalent Acquires Cook Pharmica

PAO-M09-17-NI-028
Biosimilar

Another Biosimilar Gets FDA Nod

PAO-M09-17-NI-011
Partnership

Collaboration Seeks Novel Pancreatitis Therapies

PAO-M08-17-NI-037
Biologics

New FDA Draft Guidance on Manufacturing Changes for Biologics Issued

PAO-M08-17-NI-034
Capacity Expansion

Boehringer Ingelheim Expands Biologics Manufacturing Capacity in California

PAO-M08-17-NI-007
CDMO

Biopharmaceutical Manufacturing Goes Mainstream

PAP-Q2-17-FA-004
Excipients

Celanese on the Road to BIO: Excipients In Biologics

Dr. Donald Loveday – Customer Applications Director, Pharma and Medical, Celanese. View more about Celanese on the Road to BIO.

PTV-M06-17-CL-010
Biologics

Sanofi Will Increase Investments in Biologics

PAO-M06-17-NI-012
Biologics

Pharma Revs Up Cancer-Fighting CAR T-Cell Therapy

MCP-M06-17-NI-001
Biologics

The Road to Biologics’ Continued Success

PAP-Q2-17-EN-001
Biologics

Biologics: Driving Force in Pharma

PAP-Q2-17-NO-001
Biologics

Propagating a Full Spectrum of Services for ADC Development and Manufacture

PAP-Q2-17-CL-007
Biologics

Making Strides: Biologics Push Forward

PAP-Q2-17-FA-001
Biologic

Q: If You Could Have One Piece of Biologic Manufacturing Equipment Improved, What Would It Be and Why?

PAP-Q2-17-RT-001
Roundtable

Q: Has Downstream Processing Technology Caught up with the Significantly Higher Titers Coming Out of the Current Upstream Process? If No, What Issues Remain?

PAP-Q2-17-RT-004
Roundtable

Q: What is the Most Significant Recent Advancement in Downstream Bioprocessing Technology? Why is it so Important?

PAP-Q2-17-RT-002
HPAPI

The Introduction of Robotics: Creating a Truly Sterile Environment

Jason S. Collins, Director, Process Architecture, IPS

 

PTV-M03-17-IN-001
Biologics

Biosimilar Era Begins to Blossom

PAO-M04-17-NI-027
CDMO

Bioprocessing Capacity is in High Demand

PAO-M04-17-NI-022
CDMO

Cobra Biologics Invests in Gene Therapy

PAO-M04-17-NI-020
CDMO

Grand River Has Come a Long Way

Tom Ross, President and CEO, Grand River

PTV-M11-16-AP-026
Biologics

Dan Peizer Reveals Catalant’s Newest Acquisition

Dan Peizer, Global Director of Corporate Marketing, Catalent

PTV-M11-16-AP-027
Biologics

Keeping it Clean

Malcolm McLaughlin, Vice President Of Business Development, Alconox

PTV-M11-16-AP-005
Biologics

Hiring Top Talent in Pharma

Robert Hoyle, President, Global Talent Solutions

PTV-M11-16-AP-009
Biologics

GermFree Bio Introduces Mobile GMP Cleanroom Platform

PAO-M04-17-NI-009
CDMO

Sanofi, Lonza Invest in Large-Scale Biologics Partnership

PAO-M03-17-NI-007
API

Changes in the Wind for the CDMO Market

PAP-Q1-17-FA-002
Excipients

Spending on Excipients Grows & Diversifies

PAP-Q1-17-FA-004
CDMO

Flexible Partnership, Inflexible Quality

PAP-Q1-17-CL-016
Biologics

Investing for Successful Advancement of Viral Vector Manufacturing

PAP-Q1-17-CL-007
Biologics

Cell Line Development for Therapeutic Recombinant Proteins

MCP-M02-17-NI-001
CDMO

Viral Clearance: Risk Mitigation in Biopharmaceutical Manufacturing

APR-M12-NI-16-001
CDMO

The Rise of Biosimilars

PMO-M12-NI-16-001
CDMO

Investment in Biopharma Facilities Continues

PMO-M11-16-NI-001
Biologics

INNOVATION: Creating Solutions for Healthcare’s Ambitious Agenda

PAP-Q04-16-FA-001
API

Finding The Ideal Partner for Your Next Biotherapeutic

PAP-Q04-16-CL-013
API

A Look at Recent Pharma Industry Innovations

PAP-Q04-16-NO-001
CDMO

Pharmaceutical Packaging: Differentiation Equates to Brand Loyalty

PAP-Q04-16-VP-001
CDMO

Achieving Successful Treatment Outcomes Through the Delivery of Manufacturing Services

PAP-Q04-16-CL-012
Biologics

Achieving Continuous Downstream Bioprocessing

PAP-Q04-16-CL-009
CDMO

Harnessing CDMO Expertise for Fill-Finish and Inspection of Sterile Pharmaceuticals

PAP-Q03-16-CL-015
Biologics

Applying Advanced Protein Engineering Technologies to Biotherapeutic Development

PAP-Q03-16-CL-009
Biopharmaceuticals

Controlling Glycosylation for Improved Product Quality

BIO-M06-16-NI-001
CDMO

Enabling Right-First-Time Tech Transfer with Effective Scale-Down Modeling

PAP-Q02-16-CL-002
CDMO

Biopharma’s Ascendant Supply Chain Reveals its Present Potential & Future Promise

PAP-Q02-16-FA-001
CDMO

Single-Use Equipment Proving Useful Managing Biomanufacturing Costs

PAP-Q02-16-NI-002
Biologics

Scale-Down Models: An Indispensable Tool to Biopharmaceutical Process Development

PAP-Q02-16-CL-008
CDMO

Rigorous Integration in a Scalable Development and Manufacturing Enterprise to Support Continued Growth of Biopharmaceuticals

PAP-Q02-16-CL-011
Biologics

Innovation at the Heart of Biopharmaceutical Industry Growth

PAP-Q02-16-NO-001
Biologics

Biosimilars: Are We on the Edge of a New Era of Biologics?

PAP-Q02-16-RT-002
CDMO

Advancing Biologics Development and Manufacturing

PAP-Q1-16-CL-011
API

Single-Use Now Key Technology in Biopharmaceutical Manufacturing

POP-M01-16-NI-001
CDMO

Will Biosimilars Make a Difference for the CMO/CDMO Market?

POP-M11-15-NI-001
Biologics

The Buzz Around Oncology — Update On Biologics Approvals

LSL-M11-15-NI-001
Biologics

Be Innovative! Maneuvering the Global Pharmaceutical Market

PAP-Q4-15-NO-001
CDMO

A Look At 2015 Outsourcing Trends And What To Expect In 2016

LSL-M10-15-NI-001
CDMO

From Cell Culture to Cell Therapy – Drug Applications Continue To Surge As Science Grows

API

Suiting a Strategy to Fit Biotech Behaviours

MCP-M07-15-NI-001
API

Biologics Account for an Increasing Share of Outsourcing Spending

MCP-M06-15-NI-001
Biologics

CRO Outsourcing Trends For 2015: The Move to the Cloud, the Web and Mobile Technology Continues

POP-M05-15-NI-001
CDMO

Four Keys to Successful Biopharmaceutical Outsourcing: Technical Expertise, Quality, Reliability and Timeliness

PAP-APR-S01-CL-001
Biologics

Bioreactor Preferences from an Outsourcing Perspective – Part I

PMP-M02-15-NI-001
Biologics

Logistics Providers Strive to Fulfill Biopharma Needs – Specialty Companies Offer Advantages, but Get a Bad Rap on Price

LSL-M11-14-NI-002
Biologics

Outsourcing Biomanufacturing Continues to Grow in Frequency

LSL-M07-14-NI-003
API

Outsourcing Trends in Small Molecule API Manufacturing

LSL-M07-14-NI-001
Biologics

Pre-filled Syringe Technology Benefits Patients, Healthcare Providers and Drug Makers

CIO-M06-14-NI-001
Biologics

Biologics Development Continues To Rise At Traditional Pharma Companies — What Does It Mean For Outsourcing?

CIO-M05-14-NI-001
API

Trends in Outsourcing Solid Dose Manufacturing in 2014

LSL-M03-14-NI-002
Biologics

Outsourcing To CROs And CMOs In Emerging Markets In 2014

CIO-M01-14-NI-002
API

API Manufacturing: Strategic Partnering Preferences with CMOs Vary Among Small Molecule, High Potency and Biologic API

CIO-M12-13-NI-001
Biologics

Using 2013 Trends by Buyer Group to Plan Your Outsourcing Initiatives

CIO-M11-13-NI-001
Biologics

Outsourcing Biomanufacturing

CIO-M09-13-NI-001
Biologics

CROs and CMOs Continuing Drug Delivery Innovation

CIO-M08-13-NI-001
Biologics

Biotherapeutics Outpace Conventional Therapies

BIO-M03-12-NI-001
Biologics

Spending Trends in the CMO and CRO Market

PPO-M01-12-NI-001
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