January 24th 2025
The collaboration will combine fully automated and digitalized technologies to reduce CGT manufacturing timelines to 2.5 days.
January 22nd 2025
Cytiva will combine its CGT manufacturing technologies with Cellular Origins' robotic manufacturing platform.
January 21st 2025
The company will be featuring its sustainable packaging solutions at the event in Paris on Jan. 22–23, 2025.
January 20th 2025
The two companies will be exhibiting together after Gerresheimer’s December 2024 acquisition of Bormioli.
January 17th 2025
Production is set to take place at Samsung Biologics’ Songdo, South Korea, site, and the agreement will run through December 2030, subject to change.
The evolution of therapeutic modalities drives the adoption of single-use technologies.
Achieving Manufacturing Excellence
Moving to the next level of productive, reliable performance in bio/pharmaceutical manufacturing requires a willingness to make changes and create a quality culture.
GMP Facility Modernization: Opportunities for Successful Implementation
The DME Facility Focus survey revealed best practices for coping with the challenges of aging facilities and implementing facility modernization.
EU and US Pledge to Recognize Each Other’s GMP Inspections
The Mutual Recognition Agreement will allow FDA and EU inspectors to recognize each other’s work and avoid the duplication of drug inspections.
Integrating Industrial Internet of Things and Pharmaceutical Manufacturing Processes
Industry experts discuss IIoT and its impact on pharmaceutical manufacturing.
Operational Excellence at Baxter BioPharma Solutions
Pharmaceutical Technology spoke with Frank Generotzky, plant manager for Baxter BioPharma Solutions’ Halle, Germany facility, about operational excellence at the site.
Key Considerations in Capsule Filling
Capsule filling is a complex process, and the product to be encapsulated must be well developed to ensure mass uniformity.
Harnessing Advances in Informatics to Ensure Data Integrity
Although best practices are key, advances in integrated informatics platforms and automation can make it easier to ensure data integrity and improve overall lab efficiency.
Serialization Hits the Home Stretch
As the November 2017 deadline nears, a surprising number of companies still don’t have a serialization plan in place. New programs aim to get them compliant in time.
UKSCB Releases Stem Cell Lines for Development
The UK Stem Cell Bank released validated stem-cell lines for researchers developing novel cell-based therapies for clinical trials.
Insourcing vs Outsourcing: Choosing the Right Strategy
The article reviews strategies for firms with or without existing in-house capacities and the pros and cons for outsourcing bio/pharmaceutical development and manufacturing.
The Challenge of IDMP Compliance
Having an effective and granular data management process in place will enable companies to meet the requirements of IDMP as well as help usher in a new age of digital-based identification, in which organizations can easily share data across borders.
Hospira Receives FDA Warning Letter for Repeated Violations
The agency cited the company’s Kansas facility with CGMP violations similar to problems found at other Hospira facilities.
Avella Specialty Pharmacy Recalls Sterile Products
Avella issued a nationwide recall of sterile products produced at the Advanced Pharma Houston location due to inaccurate labeling.
Sanofi and Lonza Partner on mAb Cell Culture Facility in Switzerland
Sanofi and Lonza formed a joint venture to build and operate a large-scale mammalian cell culture facility for monoclonal antibody production in Visp, Switzerland.
Endo Pharmaceuticals Recalls Alprostadil
The company is voluntarily recalling one lot of Edex due to a lack of container closure integrity.
Can Bigger be Better?
The industry is becoming more consolidated, but there needs to be some strategy behind the mergers and acquisitions.
Combination Products: Regulatory and Patent Issues You Should Consider Now
The authors discuss regulatory and patent issues with combination products.
Amphastar Receives Complete Response Letter for Intranasal Opioid Overdose Med
The regulatory agency rejected the medication, citing various issues related to device use.
Momenta Receives Warning Letter for Generic Copaxone
Momenta’s fill/finish contract manufacturer, Pfizer, was cited in the letter.
Sterile Manufacturing Deviations Found at Japan Facility
FDA sent a warning letter to Sato Pharmaceutical Co., Ltd. after inspectors found deviations in the facility’s aseptic processes.
Overcoming Obstacles in Process Analytical Technology
Improved process analytical technology and new ways of thinking seek to enhance measurement and control for next-generation pharmaceutical manufacturing.
EDQM Clarifies the Role of Monographs in Determining Biosimilarity
The directorate says monographs are flexible and changeable and their compliance does not on its own determine biosimilarity in biosimilars.
Synergy Rx Pharmacy Issues Recall Due to Lack of Sterility
The company has voluntarily recalled all lots of of human chorionic gonadotropin because of a lack of sterility assurance.
Using Spectroscopic and Virtual Sensor PAT in Continuous Solid-Dosage Manufacturing
Soft sensors are powerful tools that can be used along with spectroscopic instruments in on-line measurement.
Aurobindo Adds Four Biosimilars From TL Biopharmaceutical
Aurobindo has added four cell-culture derived biosimilars to its product line.
GPhA Rebrands as AAM
The Generic Pharmaceutical Association announces a rebranding campaign to expand access to medicines.
Drug Shortage Survey Points to Pharma’s Supply Chain Management Weaknesses
Research by Pew Charitable Trust and ISPE suggests that inability to forecast internal demand, and poor partner alignment are among the reasons for drug shortages
Austrian Centre of Industrial Biotechnology and GE Healthcare Form Cell Line Engineering Pact
This three-year partnership will explore and identify new tools and methods to modify and optimize the Chinese hamster ovary (CHO) cell line performance.
ISPE Announces 2017 Facility of the Year Award Winners
The International Society for Pharmaceutical Engineering (ISPE) and its Facility of the Year Awards program announced its 2017 category award winners.
How to Select Pharmaceutical Dust Collectors in Accordance with the New ASHRAE Standard 199
The pharmaceutical industry now has a way to accurately evaluate and compare dust collection systems that are self-cleaning