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Novasep to Manufacture Mydicar API
To provide custom biomanufacturing for commercial production
02.17.15
Biologics, Proteins, Vaccines
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7 Top Trends in Biomanufacturing Outsourcing
Keep your eye on these trends in 2015.
Eric S. Langer and Jean-Claude Lupis, BioPlan Associates
01.29.15
Bioassay Development
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Biologics, Proteins, Vaccines
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Catalent, Valerion in Biologics Development Pact
Catalent to provide cell line engineering, process development, and manufacturing
12.02.14
Biologics, Proteins, Vaccines
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Breaking News
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Amgen Opens Next-Gen Bio-Mfg. Facility in Singapore
Incorporates multiple technologies aimed at greater speed and efficiency
11.20.14
APIs
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Capsules
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Extractables and Leachables
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Regulatory Affairs
Newsmakers: CMOs and CDMOs Have a Trade Association to Call Their Own
The new Pharma & Biopharma Outsourcing Association aims to help advance the industry’s regulatory, legislative and business interests.
11.13.14
Biosimilars
|
Process Development
Biopharm Executives Point to Better CMO Performance
Better process control and increased adoption of single-use systems played a part in improving downstream manufacturing
Eric S. Langer, BioPlan Associates, Inc.
10.14.14
APIs
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Breaking News
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Capsules
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Process Development
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Regulatory Affairs
Pharma & Biopharma Outsourcing Association Formed
PBOA to represent CMO/CDMO interests
09.24.14
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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Process Development
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Validation
EMD Millipore Expands Biomanufacturing Center in Japan
Training center to aid biopharma companies with manufacturing challenges
08.27.14
4 Merck & Co.
...
07.21.14
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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Facilities
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Fill/Finish
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GMPs/GCPs
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Industry News
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Lyophilization
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Process Development
Repligen Acquires Refine’s Bioprocessing Business
Gains Alternating Tangential Flow (ATF) System
06.03.14
Breaking News
|
cGMP Manufacture
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Clinical Trials
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Extractables and Leachables
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Industry News
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Lyophilization
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Process Development
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Supply Chain
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Toxicology
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Validation
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Vials
AIBioTech Acquires ImmunoTox
Kemwell expands lyophilization capacity
04.03.14
Biosimilars
|
Clinical Trials
|
Drug Delivery
|
Fill/Finish
Alvotech and Finesse Enter Bio-Manufacturing Pact
Catalent, CiRA in regenerative therapy pact
04.03.14
Breaking News
Catalent Ups Stake in Redwood Bioscience
...
04.03.14
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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Facilities
|
Fill/Finish
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GMPs/GCPs
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Industry News
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Lyophilization
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Process Development
Catalent Ups Stake in Redwood Bioscience
SMARTag ADC Technology achieves key milestone
Kristin Brooks
03.24.14
Bio News
|
Biosimilars
|
Breaking News
|
Capsules
|
Extractables and Leachables
|
Facilities
|
Fill/Finish
|
GMPs/GCPs
|
Lyophilization
|
Process Development
Alvotech and Finesse Enter Bio-Mfg. Pact
Will leverage SmartFactory single-use automation platform
Kristin Brooks
03.14.14
Biosimilars
|
cGMP Manufacture
|
Toxicology
Too Much CMO Capacity?
...
Eric A. Langer, BioPlan Associates
03.07.14
Breaking News
|
Capsules
|
cGMP Manufacture
|
Clinical Trial Materials
|
Extractables and Leachables
|
Facilities
|
Fill/Finish
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GMPs/GCPs
|
Industry News
|
Lyophilization
|
Process Development
Gallus, Symphogen in Clinical Manufacturing Pact
To manufacture Symphogen’s antibody mixture product candidates
Kristin Brooks
02.26.14
Breaking News
|
Promotions & Moves
IPS Names Process Engineering Director
Schuster brings 25 years of global experience
Kristin Brooks
01.23.14
Breaking News
|
Promotions & Moves
IPS Appoints Compliance Director
Rezac brings international experience
Kristin Brooks
12.13.13
Bio News
|
Biologics, Proteins, Vaccines
|
Breaking News
|
Capsules
|
Clinical Trials
|
Extractables and Leachables
|
Facilities
|
Fill/Finish
|
GMPs/GCPs
|
Industry News
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Lyophilization
|
Process Development
JHL Biotech Selects GE’s FlexFactory Platform
Installation completed at Taiwan facility
12.02.13
Biologics, Proteins, Vaccines
|
Biosimilars
|
Capsules
|
Extractables and Leachables
|
Facilities
|
Fill/Finish
|
GMPs/GCPs
|
Lyophilization
|
Process Development
CMOs Demanding More Innovations
Chromatography and single-use equipment top list
Eric Langer , BioPlan Associates
11.13.13
Bio News
|
Bioassay Development
|
Biologics, Proteins, Vaccines
|
Breaking News
|
Capsules
|
cGMP Manufacture
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Drug Development
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Extractables and Leachables
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Facilities
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Fill/Finish
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GMPs/GCPs
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Industry News
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Inspections
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Lyophilization
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Methods Development
|
Process Development
|
R&D
|
Regulatory Affairs
|
Toxicology
DSM Opens Brisbane Bio-Facility
Signs pact with Opthea
Gil Roth
10.30.13
Breaking News
|
Promotions & Moves
DSM Appoints Director of Biopharm Businesses
Bouman to head DSM Biologics/BioSolutions
10.23.13
Biosimilars
|
Validation
Bio-CMO Capacity Constraints
What they’re doing about them
Eric Langer, BioPlan Associates
09.05.13
Transforming Bigfoot Into Speed Racer
The facility of the future movement in biologics manufacturing
Jeff Odum, IPS
09.05.13
Breaking News
|
Clinical Trial Materials
|
Industry News
|
Process Development
Gallus, Genzyme in Clinical Supply Pact
To provide process and method development, scale-up, clinical supply for rare disease therapy
08.01.13
Breaking News
|
Capsules
|
Clinical Trial Materials
|
Extractables and Leachables
|
Facilities
|
Fill/Finish
|
GMPs/GCPs
|
Industry News
|
Lyophilization
|
Process Development
Therapure, DVC Awarded DoD Contract
To manufacture materials for anti-nerve gas agent
06.17.13
Bio News
|
Biologics, Proteins, Vaccines
|
Breaking News
|
Capsules
|
Extractables and Leachables
|
Facilities
|
Fill/Finish
|
Formulation Development
|
GMPs/GCPs
|
Industry News
|
Lyophilization
|
Microbiology
|
Process Development
Catalent Opens Madison Bio-CoE
Quadruples bio-manufacturing capacity with single-use tech
04.26.13
Breaking News
|
Promotions & Moves
IPS Appoints Compliance Director for Latin Americas
DeSeabra brings 20 years of leadership experience
04.10.13
Clinical Trials
|
Fill/Finish
|
Process Development
|
Validation
Global Changes in Biomanufacturing
A retrospective analysis of CMO Trends
Eric Langer, BioPlan Associates, Inc.
04.03.13
Biosimilars
|
Clinical Trials
|
Drug Delivery
|
Drug Development
|
Process Development
|
Validation
Bio-CMO Industry Trends
The market continues its upswing
William Downey and Jennifer Hartigan, HighTech Business Decisions
04.03.13
Aseptic Processing
|
Biosimilars
|
Clinical Trial Materials
|
Clinical Trials
|
Fill/Finish
|
Lyophilization
|
Process Development
|
Validation
|
Vials
Fill-Finish Innovation
Showing Sparks of Life
Ronald A. Rader and Eric S. Langer, BioPlan Associates, Inc.
03.13.13
Biosimilars
|
Breaking News
|
Collaborations & Alliances
Viropro, Oncobiologics in Biosimilars Pact
Aims to commercialize six products in emerging markets
02.26.13
Breaking News
|
Drug Development
|
Drug Discovery
|
Industry News
|
Methods Development
Amgen Licenses DSM’s XD Cell Culture Patents
Technology is applicable to multiple biological products
01.15.13
Bioassay Development
|
Clinical Trial Materials
|
Clinical Trials
|
Drug Development
|
Drug Discovery
|
Laboratory Testing
|
Logistics
|
Methods Development
|
Process Development
|
Toxicology
|
Validation
Clinical Testing Technology
Applying flow cytometry to clinical trial samples
Kevin Maskell, Merck Millipore
11.09.12
Biosimilars
Biosimilars: The Race to Market Continues…
Going for the Gold
Fiona Greer, SGS Life Science Services
10.09.12
Biologics, Proteins, Vaccines
|
Capsules
|
Extractables and Leachables
|
Facilities
|
Fill/Finish
|
GMPs/GCPs
|
Lyophilization
|
Process Development
|
Scale-up/Technology Transfer
Future Bio-Capacity Constraints
Top 10 factors from a new survey
Eric S. Langer, BioPlan Associates, Inc.
09.06.12
Analytical Services
|
Bioanalytical Services
|
Bioassay Development
|
Biologics, Proteins, Vaccines
|
Biosimilars
|
Process Validation
|
Toxicology
Continuous Flow Manufacturing
Implications on downstream biologics processing
Aloke Das, Beroe Inc.
09.06.12
Bio News
|
Biologics, Proteins, Vaccines
|
Breaking News
|
Capsules
|
Clinical Trial Materials
|
Clinical Trials
|
Drug Discovery
|
Extractables and Leachables
|
Facilities
|
Fill/Finish
|
GMPs/GCPs
|
Industry News
|
Laboratory Testing
|
Lyophilization
|
Process Development
WuXi PharmaTech To Make HIV MAb for TaiMed
Biomanufacturing deal covers global Phase II-III trials
Gil Roth
08.28.12
Analytical Services
|
Bio News
|
Bioanalytical Services
|
Bioassay Development
|
Biologics, Proteins, Vaccines
|
Breaking News
|
Capsules
|
Clinical Trials
|
Drug Development
|
Extractables and Leachables
|
Facilities
|
Fill/Finish
|
GMPs/GCPs
|
Lyophilization
|
Methods Development
|
Process Development
|
R&D
|
Toxicology
Fujifilm Diosynth To Expand Bio-Capabilities
Will boost cGMP mammalian cell culture at Billingham
Gil Roth
06.19.12
Bio News
|
Bioassay Development
|
Biologics, Proteins, Vaccines
|
Breaking News
|
Capsules
|
Drug Development
|
Extractables and Leachables
|
Facilities
|
Fill/Finish
|
GMPs/GCPs
|
Lyophilization
|
Methods Development
|
Process Development
|
R&D
|
Scale-up/Technology Transfer
|
Toxicology
DSM Adds XD Client
Major pharma signs commercialization deal
Gil Roth
06.18.12
Breaking News
|
Capsules
|
Extractables and Leachables
|
Facilities
|
Fill/Finish
|
GMPs/GCPs
|
Industry News
|
Lyophilization
|
Process Development
GE Healthcare Completes Xcellerex Acquisition
Expands biomanufacturing services
05.10.12
Analytical Services
|
Aseptic Processing
|
Bioanalytical Services
|
Bioassay Development
|
Biologics, Proteins, Vaccines
|
Biosimilars
|
Capsules
|
Clinical Trial Materials
|
Clinical Trials
|
Extractables and Leachables
|
Facilities
|
Fill/Finish
|
GMPs/GCPs
|
Lyophilization
|
Process Development
|
Process Validation
|
Scale-up/Technology Transfer
|
Toxicology
Bio-CMO Industry Trends
Recent initiatives in biopharma contract manufacturing
William Downey, HighTech Business Decisions
05.04.12
Analytical Services
|
Aseptic Processing
|
Bioanalytical Services
|
Bioassay Development
|
Biologics, Proteins, Vaccines
|
Biosimilars
|
Capsules
|
Clinical Trial Materials
|
Clinical Trials
|
Drug Development
|
Extractables and Leachables
|
Facilities
|
Fill/Finish
|
GMPs/GCPs
|
Inspections
|
Logistics
|
Lyophilization
|
Methods Development
|
Process Development
|
QA/QC
|
R&D
|
Regulatory Affairs
|
Scale-up/Technology Transfer
|
Serialization
|
Supply Chain
|
Toxicology
|
Validation
Biosimilar Outsourcing Update
FDA’s draft guidance leads to new opportunities
Gil Roth, Contract Pharma
05.04.12
Breaking News
|
Capsules
|
Extractables and Leachables
|
Facilities
|
Fill/Finish
|
GMPs/GCPs
|
Lyophilization
|
Process Development
Therapure Opens New Custom Biologics Facility
Offers advanced bioprotein production
04.24.12
Drug Development
|
Logistics
There are $$Acquisitions$$ . . .
. . . and there are ¢¢acquisitions¢¢
Michael Martorelli
04.04.12
Bio News
|
Biologics, Proteins, Vaccines
|
Breaking News
|
Capsules
|
Extractables and Leachables
|
Facilities
|
Fill/Finish
|
GMPs/GCPs
|
Lyophilization
|
Process Development
GE Healthcare To Acquire Xcellerex
Boosts single-use biopharma manufacturing business
Gil Roth
03.07.12
Analytical Services
|
Bioanalytical Services
|
Bioassay Development
|
Capsules
|
Cleaning Validation
|
Extractables and Leachables
|
Facilities
|
Fill/Finish
|
Formulation Development
|
GMPs/GCPs
|
Inspections
|
Laboratory Testing
|
Lyophilization
|
Methods Development
|
Process Development
|
Process Validation
|
QA/QC
|
Solid Dosage/Semi-solids
|
Toxicology
|
Validation
|
Vials
Manufacturing Equipment Trends
Industry perspective from suppliers and manufacturers
Online Exclusives
Kristin Brooks, Associate Editor
03.07.12
Bio News
|
Biologics, Proteins, Vaccines
|
Biosimilars
|
Breaking News
|
Capsules
|
Collaborations & Alliances
|
Extractables and Leachables
|
Facilities
|
Fill/Finish
|
GMPs/GCPs
|
Lyophilization
|
Process Development
GE, M+W in Biosimilar Engineering Pact
To develop biomanufacturing facilities in emerging markets
Gil Roth
12.14.11
Breaking News
|
Process Development
Catalent To Increase Biologic Capabilities
New Wisconsin facility will quadruple capacity
12.07.11
Breaking News
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
Moderna and OpenAI Join Forces to Transform Healthcare with AI
CureVac Names New Chief Business Officer
View Breaking News >
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Clinical Supply CDMOs
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