FDA Guidance - Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production
OOS results fall outside acceptance criteria and trigger mandatory investigations. The process has two phases: initial laboratory assessment for errors, then a full-scale investigation for root cause. The quality unit evaluates evidence and
August 22, 2025
by Muhammad Asim Niazi
LOTTE BIOLOGICS Signs Antibody Manufacturing Contract with Ottimo Pharma
LOTTE BIOLOGICS announced on June 19, 2025 that it has signed a contract manufacturing agreement for antibody therapeutics with Ottimo Pharma
June 18, 2025
by PRNewswire
Apeloa Pharmaceutical releases first ESG
Apeloa Pharmaceutical has released its first sustainability report. Apeloa’s 2024 Environmental, Social and Governance (ESG) report marks the start of continuous and responsible disclosure into the future.
May 12, 2025
by PharmaSources
Samsung Biologics presents business updates at 2025 J.P. Morgan Healthcare Conference
Samsung Biologics (KRX: 207940.KS) announced its latest business achievements and 2025 outlook at the 43rd J.P. Morgan Healthcare Conference, which was held in San Francisco between January 13-16.
January 15, 2025
by PRNewswire
BioCina and NovaCina Merger Bolsters Global CDMO Industry
Global Contract Development and Manufacturing Organizations (CDMOs) BioCina and NovaCina announced a strategic merger that will create a powerful brand in biopharmaceutical and small molecule contract manufacturing.
January 14, 2025
by PRNewswire
Vetter Introduces the Next Evolution of the V-OVS® Syringe Closure System
Vetter has announced the development and upcoming launch of the new version of its proprietary V-OVS® syringe closure system.
January 14, 2025
by PharmaSources
Celonic Inaugurates “Next Generation” Biologics Development Center (BDC) and Pilot Plant in Basel, Switzerland
The Celonic Group, a Swiss Based Quality Biologics Contract Development and Manufacturing Organization (CDMO) today opened its “Next Generation” Biologics Development Center and Pilot Plant in Basel, Switzerland.
June 24, 2024
by Biotech Newswire
Vetter Wins Best Managed Companies Award 2024
Vetter, a globally leading Contract Development and Manufacturing Organization (CDMO), has once again been awarded the Best Managed Companies Award, marking its fifth consecutive win.
May 30, 2024
by PharmaSources
Vetter Looks Ahead to Further Expansions to Meet Supply Chain Demand
Vetter, a leading global Contract Development and Manufacturing Organization (CDMO), announces additional investments as part of its long-term dedication to customer partnerships.
November 6, 2023
by B3C newswire
Vetter Earns Frost & Sullivan’s Customer Value Award for the Third Time
On August 29, 2023,Vetter has been awarded the Frost & Sullivan’s 2023 Global Customer Value Leadership Award in the aseptic fill-and-finish market for the company’s high performance for its customers.
August 30, 2023
by PharmaSources
Famous GLP-1RA Outside of the Circle, and Rapid Development of Peptide CDMO
With the famous weight-loss drugs are famous outside of the circle, such as GLP-1RA, it has also stimulated the market's demand and concern for peptide CDMO.
August 7, 2023
by Xiaobin/PharmaSources
Samanta Cimitan Appointed Chief Executive Officer (CEO) at Celonic
On August 03, 2023,Celonic Group has appointed Dr. Samanta Cimitan as the Chief Executive Officer (CEO) of the Celonic Group, a subsidiary of the independent and privately owned J.RETTENMAIER & Söhne Company (JRS Group).
August 3, 2023
by PharmaSources