cGMP Manufacture
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cGMP Manufacture | Facilities | Industry News | Inspections
Umicore API Facility Passes cGMP Audit
The plant manufactures four oncology APIs produced for global markets according to the latest international guideline06.20.18
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APIs | Breaking News | cGMP Manufacture | Collaborations & Alliances | Drug Discovery | Industry News
Enamine and TBD Biodiscovery Collaborate to Provide GMP-based Services
Collaboration combines expertise in novel chemical compound synthesis with GMP manufacture in drug discovery06.20.18
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Breaking News | cGMP Manufacture | Collaborations & Alliances | Industry News
Orion Contract Manufacturing Enters Supply Agreement with Peptonic Medical
The CMO will be responsible for the launch and ongoing supply of the product to multiple markets06.20.18
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cGMP Manufacture | Drug Development | Facilities | Fill/Finish | Formulation Development
Samsung BioLogics Details End-To-End Services
CDO Team Lead at Samsung BioLogics, Eun Young Yang, shares insight on the company’s one-stop CDMO offeringsVideos
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Biologics, Proteins, Vaccines | Breaking News | cGMP Manufacture | Collaborations & Alliances | Industry News
Brammer Bio, Sarepta Enter Long-term Mfg. Tie-up
Partnership will provide commercial supply for a potential micro-dystrophin gene therapy product launch06.14.18
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cGMP Manufacture | Drug Delivery | Industry News
Recipharm Acquires Sanofi’s UK CMO Biz
Expands inhalation capabilities with commercial drug product manufacturing06.13.18
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cGMP Manufacture
The Good, The Bad, and The Ugly Complexities of Pharmaceutical Manufacturing
What does it really take to develop, design, scale-up, commercialize and manage continuous processes?Girish Malhotra, Contributing Editor 06.12.18
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cGMP Manufacture | Industry News | Inspections
Pii Gets Positive Inspection News from FDA and MHRA
Previously restricted GMP Certificate withdrawn based on recent inspections by the FDA06.11.18
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cGMP Manufacture | Collaborations & Alliances
Stelis Biopharma, Oncobiologics Form Bio2Source
The newly formed unit will offer development stage biotech companies access to a suite of CDMO services06.05.18
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cGMP Manufacture | Clinical Trial Materials | Industry News
Adocia, Tonghua Dongbao Expand Global Supply Pact
Tonghua will manufacture and supply insulin glargine and insulin lispro to Adocia worldwide, excluding China06.01.18
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cGMP Manufacture | Industry News | Promotions & Moves
Ajinomoto Althea Makes Key VP Hires
Bert Barbosa to serve as VP of Drug Product Manufacturing and Darwin Richardson to serve as VP of Compliance05.31.18
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cGMP Manufacture | Collaborations & Alliances | Information Technology
Werum IT, Nymi Enter MES Partnership
To develop joint solutions for smart authentication of employees on the pharmaceutical shop floor05.31.18
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Bio News | cGMP Manufacture | Collaborations & Alliances | Drug Development | Drug Discovery | Industry News
Zai Lab, Crescendo Biologics Enter Licensing Agreement
Zai Lab will develop, commercialize, and manufacture a topical antibody VH domain therapeutic for inflammatory indications05.30.18
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cGMP Manufacture | Collaborations & Alliances
Elite Pharma, Glenmark in Strategic Alliance
License, manufacturing, and supply agreement covers two Elite generic products in the U.S05.29.18
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cGMP Manufacture | Collaborations & Alliances | Drug Development | Facilities | Industry News
Eurofins, Astellas Sign Outsourcing Agreement
Astellas has committed to provide ASL work covering its current capacity for an agreed period of time05.29.18
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Bio News | cGMP Manufacture | Industry News | Regulatory Affairs | Risk Management
Stellar Announces Positive Third-Party Trial Results
The company's KLH manufacturing methods have achieved robust viral clearance05.29.18
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Bio News | cGMP Manufacture | Facilities | Industry News
Ecolab Details Ongoing Expansion & New Facility
The 3,000 sq ft ISO 5- & ISO 7-certified cleanroom production area will be housed within the new 12,000-square-foot facilityOnline Exclusives Betsy Louda, Associate Editor 05.24.18
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cGMP Manufacture | Industry News | Inspections
Samsung BioLogics Receives Additional FDA Approval
Gains third approval for Plant 2 in 26 months05.24.18
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cGMP Manufacture | Industry News | Regulatory Affairs
Recipharm Plans for Brexit
Establishes a dedicated taskforce to manage the potential impact on ops05.24.18
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Bio News | cGMP Manufacture | Industry News
Genvion Adds Spray Drying Capabilities
The new capabilities will bring spray dryers and Wurster coaters on-line05.21.18
