Search results for " collaboration" in Articles / App Notes
Article
Improving Process-Scale Chromatography
Advances in technology are increasing the productivity and efficiency of commercial-scale chromatography bioprocesses.
By Cynthia Challener, PhD
Chromatography is a crucial step in the purif…
Article
Efforts Accelerate to Streamline Postapproval Change Process
Manufacturers and regulatory authorities seek coordinated lifecycle management policies.
By Jill Wechsler
Frequent revisions and updates in manufacturing processes and operations are routine…
Article
Modeling Bioreactor Performance
…ng, which is creating an opportunity for manufacturers to characterize their systems, potentially in collaboration with their customers, and develop better models for scaling.
Clapp also stresses…
Article
Design and Qualification of Single-Use Systems
Adoption of established good engineering practices for design and deployment of SUTs is crucial and requires close collaboration between users, component designers and system engineers having experien…
Article
Managing Biomanufacturing Capacity Expectations
Capacity for complex therapeutics is becoming increasingly difficult to predict.
By Randi Hernandez
Demand for any given new product is typically only known after significant investments h…
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A Q&A With Jeff Carter on Trends in Single-Use Technologies
Process Development Forum speaks with Jeff Carter, Strategic Projects Leader at Cytiva, and first Vice Chair on the executive board of the Bio-Process Systems Alliance (BPSA).
What general trend…
Article
Innovative Therapies Require Modern Manufacturing Systems
FDA and industry see progress and challenges in bringing cutting-edge medicines to patients.
By Jill Wechsler
FDA set a 19-year record in 2015 in approving more new drugs and biologics, and …
Article
Biopharma in 2015: A Year for Approvals and Innovations
Insiders agree that 2015 was a banner year for biopharma. Last year’s new drug approvals reached 51, besting every year since 1950. Twenty approvals (39%) went to biological drugs—up from 35% in 201…
Article
GMP Challenges for Advanced Therapy Medicinal Products
Finalizing GMP requirements and quality standards for the development, manufacture, and clinical testing of ATMPs in the EU is proving to be a complex task.
By Sean Milmo
A consultation period…
Article
USP Stresses Pharmacopeial Standards at CPhI China
“We will strengthen our collaboration with the Chinese Pharmacopoeia Commission and other partners to share knowledge on pharmacopeial standards, promote industry developments, and improve public heal…