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West, Amgen in Container Pact
Will assess Daikyo Crystal Zenith technologies for containment
Gil Roth
06.21.12
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Clinigen CTS To Distribute Accord Drugs in EU
Agreement covers clinical trial distribution for Intas unit's injectable oncology portfolio
Gil Roth
06.20.12
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Biologics, Proteins, Vaccines
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Vetter Expands PFS Services
New Ravensburg line to handle one million prefilled syringes a day
Gil Roth
06.19.12
Breaking News
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Fill/Finish
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Industry News
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Parenterals
Unilife Gets PFS Contract
Seven-year deal for commercial supply of prefilled syringe
Gil Roth
06.19.12
Bio News
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Breaking News
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Industry News
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Inspections
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Lyophilization
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Vials
Cook Pharmica Gains Commercial Manufacturing Approval
FDA inspection covers new filling line lyophilization capabilities, and quality systems
06.19.12
Breaking News
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Lachman Consultants Names Director
Jaworski to head compliance practice
06.08.12
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Scale-up/Technology Transfer
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CMOs and Final Dosage Manufacturing in China
The far east market evolves
Oliver Mueller and Clifford Mintz, Suzhou Pharma Services and BioInsights
05.30.12
Aseptic Processing
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Capsules
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Chemistry
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Newsmakers: Clive Bennett
Halo CEO Clive Bennett
Gil Y. Roth, Contract Pharma
05.30.12
Drug Delivery
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Injectables
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Parenterals
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Vials
U.S. CMO Market Report
A growth industry in transition
Jesse Sullivan and Jennifer Brice, Frost & Sullivan
05.30.12
Analytical Services
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Bioassay Development
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Capsules
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Clinical Trials
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Cytotoxics and High Potency Manufacturing
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Drug Development
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Facilities
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R&D
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Solid Dosage/Semi-solids
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Toxicology
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Validation
Newsmakers: Jim Mullen
Patheon's CEO talks about his first year on the job
Gil Y. Roth, Contract Pharma
05.04.12
Analytical Services
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Aseptic Processing
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Bioanalytical Services
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Bioassay Development
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Biologics, Proteins, Vaccines
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Biosimilars
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Capsules
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Clinical Trials
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R&D
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Scale-up/Technology Transfer
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Serialization
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Supply Chain
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Toxicology
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Biosimilar Outsourcing Update
FDA’s draft guidance leads to new opportunities
Gil Roth, Contract Pharma
05.04.12
Bio News
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Biologics, Proteins, Vaccines
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Breaking News
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Capsules
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Extractables and Leachables
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Trials & Filings
FDA, EMA Approve Genzyme Line
Fill/finish line in Ireland to double Myozyme, Lumizyme capacity
Gil Roth
05.03.12
Breaking News
|
Industry News
|
Parenterals
Vetter To Continue Expansion Efforts
Secures loan for new filling capacity and expanded facilities invesmtents
05.01.12
Breaking News
|
Lyophilization
|
Packaging & Tracking
West Adds NovaPure Components
New line utilizes QbD principles to enhance safety, efficacy
04.16.12
Aseptic Processing
|
Microbiology
|
Parenterals
|
Vials
Sterile Products
...
Aseptic Processing
|
Biologics, Proteins, Vaccines
|
Capsules
|
Cytotoxics and High Potency Manufacturing
|
Drug Delivery
|
Fill/Finish
|
Formulation Development
|
Parenterals
|
Process Validation
|
Solid Dosage/Semi-solids
|
Vials
Parenteral Packaging Considerations
Pairing the product, package and process for parenterals
Andrea Wagner
04.04.12
Fill/Finish
|
GMPs/GCPs
|
Inspections
|
Logistics
|
Regulatory Affairs
|
Risk Management
|
Serialization
|
Supply Chain
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Vials
Packaging Trends and Anti-counterfeiting Initiatives
Contract packagers and suppliers see opportunities
Kristin Brooks
04.04.12
Analytical Services
|
Aseptic Processing
|
Bioanalytical Services
|
Bioassay Development
|
Biologics, Proteins, Vaccines
|
Capsules
|
Clinical Trial Materials
|
Cytotoxics and High Potency Manufacturing
|
Drug Delivery
|
Drug Development
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Extractables and Leachables
|
Facilities
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Fill/Finish
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Formulation Development
|
GMPs/GCPs
|
Injectables
|
Inspections
|
Lyophilization
|
Methods Development
|
Microbiology
|
Parenterals
|
Process Development
|
Process Validation
|
QA/QC
|
Solid Dosage/Semi-solids
|
Supply Chain
|
Toxicology
|
Validation
|
Vials
Parenteral Outsourcing Trends
More opportunities, but greater regulatory scrutiny
04.04.12
Breaking News
|
Parenterals
|
Promotions & Moves
|
Vials
AMRI Appoints Senior Facilities Manager
Rossmeisl will oversee Burlington, MA facilities
03.27.12
Aseptic Processing
|
Breaking News
|
Capsules
|
Clinical Trial Materials
|
Clinical Trials
|
Cytotoxics and High Potency Manufacturing
|
Extractables and Leachables
|
Facilities
|
Fill/Finish
|
Formulation Development
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GMPs/GCPs
|
Industry News
|
Lyophilization
|
Process Development
SCM Wins UK Business Award
commended for commitment to aseptic processing and filling capabilities
03.27.12
Analytical Services
|
Bioanalytical Services
|
Bioassay Development
|
Biologics, Proteins, Vaccines
|
Breaking News
|
Drug Delivery
|
Drug Development
|
Industry News
|
Methods Development
|
Process Development
|
Toxicology
Particle Sciences Acquires LyoCell Portfolio
Will offer bioavailability solutions to clients
03.08.12
Breaking News
|
Parenterals
|
Promotions & Moves
|
Vials
AMRI Expands QC Team
McGrath and Phillips to head QC at Burlington site
02.29.12
Parenterals
Small Volume Parenteral (SVP)
...
02.27.12
Parenteral Drug
...
02.27.12
Large Volume Parenteral (LVP)
...
02.27.12
Parenterals
Center for Drug Evaluation and Research (CDER)
...
02.27.12
Aseptic Processing
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Bio News
|
Biologics, Proteins, Vaccines
|
Breaking News
|
Capsules
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Extractables and Leachables
|
Facilities
|
Fill/Finish
|
GMPs/GCPs
|
Industry News
|
Lyophilization
|
Parenterals
|
Process Development
Jubilant HollisterStier Wins Four Contracts
Will manufacture sterile parenteral products at Spokane facility
Gil Roth
02.22.12
Drug Discovery
|
Lyophilization
JHS Secures Multi-Million Dollar Contracts to Manufacture Sterile Parenteral Products
...
Breaking News
|
Capsules
|
Extractables and Leachables
|
Facilities
|
Fill/Finish
|
GMPs/GCPs
|
Lyophilization
|
Parenterals
|
Process Development
|
Promotions & Moves
|
Regulatory Affairs
|
Supply Chain
Hospira Appoints Quality Expert
Adds several new operations and quality leaders
02.14.12
Breaking News
|
Clinical Trial Materials
|
Clinical Trials
|
Industry News
|
Parenterals
|
Vials
Florida Biologix Meets EU Compliance
Expands aseptic fill-finish capabilities for clinical biologics
02.02.12
Aseptic Processing
|
Biologics, Proteins, Vaccines
|
Breaking News
|
Parenterals
|
Promotions & Moves
|
Supply Chain
SCHOTT Names Syringe VP
Muguet to lead global syringe business
Gil Roth
02.02.12
Breaking News
|
Lyophilization
|
Promotions & Moves
Coldstream Appoints Tech Transfer Manager
Maclean brings 20 years of experience
01.23.12
Biologics, Proteins, Vaccines
|
Cold Chain Management
|
Extractables and Leachables
|
Facilities
|
GMPs/GCPs
|
Logistics
|
Methods Development
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Parenterals
|
Process Development
|
QA/QC
|
Serialization
|
Supply Chain
|
Validation
Lengthening of The Last Mile
New questions about maintaining drug quality
Kevin O'Donnell
01.23.12
Analytical Services
|
Aseptic Processing
|
Bioanalytical Services
|
Bioassay Development
|
Chemistry
|
Drug Delivery
|
Drug Development
|
Extractables and Leachables
|
Facilities
|
Fill/Finish
|
GMPs/GCPs
|
Inspections
|
Laboratory Testing
|
Logistics
|
Methods Development
|
Parenterals
|
Process Development
|
QA/QC
|
Risk Management
|
Serialization
|
Supply Chain
|
Toxicology
|
Validation
|
Vials
The Glass Quandary
Glass breakage, delamination and compatibility with biologics have boosted interest in novel materials in pharma packaging
Fran DeGrazio and Diane Paskiet
01.23.12
Aseptic Processing
|
Breaking News
|
Extractables and Leachables
|
Facilities
|
Fill/Finish
|
GMPs/GCPs
|
Methods Development
|
Parenterals
|
Process Development
|
Promotions & Moves
|
QA/QC
|
Toxicology
|
Validation
AAIPharma Names Charleston Quality Director
Uribe to oversee parenteral facility
Gil Roth
01.18.12
Aseptic Processing
|
Breaking News
|
Capsules
|
Clinical Trial Materials
|
Clinical Trials
|
Cytotoxics and High Potency Manufacturing
|
Extractables and Leachables
|
Facilities
|
Fill/Finish
|
GMPs/GCPs
|
Industry News
|
Lyophilization
|
Parenterals
|
Process Development
Carbogen Amcis Acquires Creapharm Parenterals
Acquisition will extend drug product offerings
Gil Roth
01.16.12
Analytical Services
|
Bioanalytical Services
|
Bioassay Development
|
Biologics, Proteins, Vaccines
|
Breaking News
|
Capsules
|
Clinical Trial Materials
|
Clinical Trials
|
Drug Development
|
Extractables and Leachables
|
Facilities
|
Fill/Finish
|
Formulation Development
|
GMPs/GCPs
|
Industry News
|
Lyophilization
|
Methods Development
|
Parenterals
|
Process Development
|
Solid Dosage/Semi-solids
|
Toxicology
Microtest To Manufacture Nexvax2
Will provide clinical materials, support to ImmusanT
Gil Roth
01.11.12
Breaking News
|
Capsules
|
Cleaning Validation
|
Cytotoxics and High Potency Manufacturing
|
Extractables and Leachables
|
Facilities
|
Fill/Finish
|
GMPs/GCPs
|
Industry News
|
Injectables
|
Inspections
|
Lyophilization
|
Methods Development
|
Parenterals
|
Process Development
|
QA/QC
|
Regulatory Affairs
|
Validation
Ben Venue Extends Manufacturing Stoppage
Quality issues to derail sterile injectables till 4Q12
Gil Roth
12.27.11
Analytical Services
|
Aseptic Processing
|
Bioanalytical Services
|
Bioassay Development
|
Biologics, Proteins, Vaccines
|
Fill/Finish
|
Parenterals
|
Toxicology
|
Validation
Bio-Outsourcing Budgets up (Slightly)
Sponsors funding more, different projects
Eric A. Langer
12.06.11
Aseptic Processing
|
Bioassay Development
|
Biologics, Proteins, Vaccines
|
Capsules
|
Cleaning Validation
|
Clinical Trials
|
Drug Development
|
Drug Discovery
|
Excipients
|
Extractables and Leachables
|
Facilities
|
Fill/Finish
|
GMPs/GCPs
|
Lyophilization
|
Methods Development
|
Parenterals
|
Process Development
|
Toxicology
|
Validation
|
Vials
Vaccine Update
New technologies and manufacturing platforms expand protections
Paul Di Filippo
11.14.11
Breaking News
DPT Continues Facilities Expansion
To invest another $14 million in TX and NJ
10.13.11
Analytical Services
|
Aseptic Processing
|
Bioanalytical Services
|
Bioassay Development
|
Biologics, Proteins, Vaccines
|
Capsules
|
Cytotoxics and High Potency Manufacturing
|
Extractables and Leachables
|
Facilities
|
Fill/Finish
|
Formulation Development
|
GMPs/GCPs
|
Lyophilization
|
Parenterals
|
Process Development
|
Solid Dosage/Semi-solids
|
Supply Chain
|
Toxicology
Newsmakers: Marcelo Morales
The CEO of Jubilant HollisterStier talks about integration
Gil Y. Roth
10.11.11
Aseptic Processing
|
Biologics, Proteins, Vaccines
|
Drug Delivery
|
Fill/Finish
|
Injectables
|
Parenterals
|
Validation
|
Vials
Streamlined Blow-Fill-Seal Insertion
Technology increases flexibility and safety in aseptic packaging
Andrew W. Goll
10.11.11
Aseptic Processing
|
Clinical Trials
|
Drug Delivery
|
Fill/Finish
|
Microbiology
|
Validation
|
Vials
Weathering the Storms
Don’t suffer an aseptic Fill/Finish/FAIL
Alexander Mello
10.11.11
APIs
|
Excipients
|
Extractables and Leachables
|
Facilities
|
GMPs/GCPs
|
Inspections
|
Logistics
|
Methods Development
|
Process Development
|
QA/QC
|
Regulatory Affairs
|
Serialization
|
Supply Chain
|
Validation
Supply Chain Focus: Rx-360 Pilot Program
Will audit standards help improve processes?
Tom Beil
10.11.11
Breaking News
|
Clinical Trials
|
Formulation Development
SCM To Launch Formulation Service
Will provide developmental services for liquid, oral, and topical formulations
09.13.11
APIs
|
Breaking News
|
Chemistry
|
Clinical Trial Materials
|
Clinical Trials
|
Formulation Development
|
GMPs/GCPs
|
Industry News
|
Parenterals
Catalent To Acquire Aptuit's CTS Business
Aptuit to focus on discovery, mid-phase development
Gil Roth
08.22.11
Breaking News
|
Capsules
|
Extractables and Leachables
|
Facilities
|
Fill/Finish
|
Financial Reports
|
GMPs/GCPs
|
Injectables
|
Lyophilization
|
Parenterals
|
Process Development
Financial Reports: Hospira 2Q11
Docetaxel fuels revenue growth
Gil Roth
07.27.11
Biosimilars
|
Drug Discovery
11 Teva Pharma
...
Gil Roth
07.14.11
Aseptic Processing
|
Bio News
|
Biologics, Proteins, Vaccines
|
Breaking News
|
Capsules
|
Extractables and Leachables
|
Facilities
|
Fill/Finish
|
Formulation Development
|
GMPs/GCPs
|
Lyophilization
|
Parenterals
|
Process Development
Althea Passes PAI for Commercial Parenteral
New facility will support drug product, biologics manufacturing
Gil Roth
06.28.11
Breaking News
Ascend Taps Scott Law as COO
FibroBiologics Discusses Opportunities to Work with Charles River
Lilly Acquires Manufacturing Facility from Nexus Pharmaceuticals
Kühne Holding AG Agrees to Acquire Aenova Group
BigHat Biosciences Partners with Janssen Biotech to Guide Antibody Discovery & Design
View Breaking News >
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