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Top Features
Seven Core Pieces of the Puzzle: What to Consider When Selecting an Analytical Lab
Bridging the Divide: Understanding Contrasting Approaches in Drug Development
Updates on the Value of a Day of Delay in Drug Development
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FDA Approves Roche's Itovebi for Breast Cancer
Evonik to Restructure Keto and Pharma Amino Acid Business
Hubble Therapeutics Selects Andelyn to Manufacture Clinical Grade AAV
Cellipont Bioservices, Mongoose Bio Partner to Advance MGB-001
Lipocine Enters Exclusive Supply and Distribution Agreement with Pharmalink
APIs
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Solid Dosage/ Creams/ Ointments
Evonik to Restructure Keto and Pharma Amino Acid Business
Application of QbD Approach for Tech Transfer and Process Characterization of Biologics
Rommelag CDMO
Hubble Therapeutics Selects Andelyn to Manufacture Clinical Grade AAV
Cellipont Bioservices, Mongoose Bio Partner to Advance MGB-001
Capsules
Cold Chain Management
Injectables
Logistics
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Solid Dosage / Semi-solids
Supply Chain
Vials
Nipro Launches D2F Glass Vials Using Stevanato's EZ-fill Technology
Thermo Fisher Scientific to Leverage DHL Express GoGreen Plus Service
SK pharmteco, Cryoport Partner for Cell and Gene Therapy Logistics and BioServices
Pharma Matters Q&A: Rising Above the Rest
Avara Highlights Recent Expansions and Core Capabilities
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Application of QbD Approach for Tech Transfer and Process Characterization of Biologics
Hubble Therapeutics Selects Andelyn to Manufacture Clinical Grade AAV
Arbele Enters AI Alliances in Precision Oncology and Manufacturing
Panthera Biopartners Joins Parexel Site Alliance Vaccine Network
Lilly, insitro Enter Strategic Agreements for Metabolic Diseases
Filtration & Purification
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Rottendorf Pharma Selects ValGenesis VLMS
FDA sIRB Mandate: A Chance to Reassess Site Performance
Rottendorf Pharma Selects ValGenesis’ VLMS
U.S. House of Representatives Passes the BIOSECURE Act
Post-COVID Trends in Biopharma Contract Manufacturing
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Process Validation
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APIs
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Serialization
PDUFA to Patients in 7 Days with Integrated Packaging Solutions
Join industry experts on June 20th for an engaging webinar focused on streamlining new drug launches with integrated packaging solutions.
Sponsored
released by
Cardinal Health
05.22.24
APIs
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Regis Custom Pharma
...
Deanna Rentner, Marketing Coordinator
10.26.23
Analytical Services
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Process Development
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Process Validation
Fujifilm Diosynth Biotechnologies Doubles Laboratory Footprint in North Carolina
Expands the sites’ process development, process characterization and analytical services and adds approximately 145 positions by 2024.
01.05.22
Biologics, Proteins, Vaccines
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Clinical Trials
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Drug Development
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Inspections
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Process Validation
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Risk Management
Establishing Commercial Manufacturing Services for Antibody-Drug Conjugates
Learn how to properly structure your development work, perform a thorough process risk assessment and prepare for pre-approval inspection audit.
Sponsored
released by
Merck
06.09.21
Biologics, Proteins, Vaccines
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Industry News
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Scale-up/Technology Transfer
Avid, Humanigen Enter Lenzilumab Mfg. Agreement
To expand production capacity for lenzilumab, Humanigen’s therapeutic candidate in development to treat cytokine storm associated with COVID-19.
Kristin Brooks
02.03.21
Bioanalytical Services
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Bioassay Development
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Biologics, Proteins, Vaccines
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Process Development
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Process Validation
eBook: Increase Time to Market with Precision Dispensing Technology
Discover how to make safe, productive, efficient bioprocessing a reality by exploring the benefits of precision dispensing technology.
Sponsored
released by
Roquette
10.30.20
Biologics, Proteins, Vaccines
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Process Validation
Process Validation in Biologics Development
Strategies for successful process validation in the wake of faster approval timelines.
Victor Vinci and Claudia Berdugo-Davis, Catalent Biologics
05.07.19
Bio News
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cGMP Manufacture
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Collaborations & Alliances
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Scale-up/Technology Transfer
3P Enters Mfg. Tie-up With Dutch Biotech Xenikos
3P responsible for process transfer and scale-up, cGMP production for clinical trials and process validation
03.12.19
Chemistry
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Microbiology
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Validation
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Bio News
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Vials
Grand River Breaks Ground on Major Expansion
With the support of The Right Place & the MEDC, the 60,000 sq ft facility is expected to be operational by 2020
Videos
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Scale-up/Technology Transfer
Thermo Fisher, Symphogen Enter Collaboration
To deliver validated, platform workflows for simplified characterization & quality monitoring of complex therapeutic proteins
10.29.18
Logistics
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Process Validation
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QA/QC
Nulogy Launches Quality & Compliance Solution
Capabilities provided to contract packagers are purpose-designed for compliance and GMP compatible and unique to the market
Online Exclusives
Betsy Louda, Associate Editor
10.04.18
APIs
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WuXi STA Enables Ascletis to Receive NDA Approval from China FDA for Ganovo
Is first CDMO to support the approval of an innovative drug in China through the MAH pilot program
06.14.18
Facilities
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Fill/Finish
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Process Development
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Process Validation
Hovione Strengthens Inhalation Services Portfolio
With its new MG2 Tekna Precision Capsule filling unit
01.24.18
Bioanalytical Services
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Collaborations & Alliances
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Industry News
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Methods Development
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Process Validation
vTv Therapeutics, Reneo Pharmaceuticals Enter Agreement
The licensing agreement focuses on the PPAR-delta program
12.28.17
Aseptic Processing
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Breaking News
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Facilities
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Industry News
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Process Validation
Sterigenics Expands Capacity
$17.5 million investment in Fort Worth site makes it the largest sterilization facility in the company’s network
08.02.17
Process Validation
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Regulatory Affairs
Process Validation in the Light of Annex 15 and FDA Requirements
...
12.09.16
Analytical Services
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Lyophilization
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Process Development
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Process Validation
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Validation
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Vials
Ajinomoto Bio-Pharma Services
Ajinomoto Bio-Pharma Services is a fully integrated CDMO providing comprehensive process development services, cGMP manufacturing and drug product fill finish services of small molecule and biologic APIs and intermediates.
Amber Riley, Marketing Manager
11.07.16
Capsules
|
Excipients
|
Process Validation
|
Validation
Continuous Granulation Technology Trends
Seeking a smooth path and avoiding dead ends
Dilip M. Parikh, DPharma Group
06.02.16
Process Validation
ILC Dover Demonstrates CrimpLoc System
Next-gen high containment system designed to provide secure closure in pharmaceutical processing
Videos
Breaking News
FDA Approves Roche's Itovebi for Breast Cancer
Evonik to Restructure Keto and Pharma Amino Acid Business
Hubble Therapeutics Selects Andelyn to Manufacture Clinical Grade AAV
Cellipont Bioservices, Mongoose Bio Partner to Advance MGB-001
Lipocine Enters Exclusive Supply and Distribution Agreement with Pharmalink
View Breaking News >
CURRENT ISSUE
September 2024
Seven Core Pieces of the Puzzle: What to Consider When Selecting an Analytical Lab
Bridging the Divide: Understanding Contrasting Approaches in Drug Development
Updates on the Value of a Day of Delay in Drug Development
CEO Spotlight: Matthew Stober
CDMO Specialization
Post-COVID Trends in Biopharma Contract Manufacturing
Pharma’s Next Frontier: GLP-1s and Other New Therapies
CEO Spotlight: Prasad Raje
HPAPIs Soar Riding the Targeted Drugs Wave
View More >