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Process‐wide control and automation of an integrated continuous manufacturing platform for antibodies

Biotechnology and Bioengineering, 2020
Integrated continuous manufacturing is entering the biopharmaceutical industry. The main drivers range from improved economics, manufacturing flexibility, and more consistent product quality. However, studies on fully integrated production platforms have
F. Feidl   +10 more
semanticscholar   +1 more source

Continuous Manufacturing of Bioinspired Bone‐Periosteum Integrated Scaffold to Promote Bone Regeneration

Advanced Functional Materials
The scaffold that bioinspired natural bone‐periosteum is ideal for the repair of bone defects, while the achievement of a gradient scaffold with an integrated and stable interface remains challenging.
Zhengwei Li   +8 more
semanticscholar   +1 more source

Blend uniformity monitoring in a continuous manufacturing mixing process for a low-dosage formulation using a stream sampler and near infrared spectroscopy.

International journal of pharmaceutics
Continuous manufacturing has the potential to offer several benefits for the production of oral solid dosage forms, including reduced costs, low-scale equipment, and the application of process analytical technology (PAT) for real-time process control ...
Raúl S. Rangel-Gil   +3 more
semanticscholar   +1 more source

Deep learning for continuous manufacturing of pharmaceutical solid dosage form.

European journal of pharmaceutics and biopharmaceutics, 2020
Continuous Manufacturing (CM) of pharmaceutical drug products is a new approach within the pharmaceutical industry. In the presented paper, a GMP continuous wet granulation line for production of solid dosage forms was investigated. The line was composed
Y. Roggo   +4 more
semanticscholar   +1 more source

Implementing PAT for single-pass tangential flow ultrafiltration for continuous manufacturing of monoclonal antibodies

, 2020
Control of single pass tangential flow ultrafiltration is crucial for continuous manufacturing of monoclonal antibodies. We propose a strategy to control the output concentration of a continuous ultrafiltration step regardless of variations in the volume
Garima C. N. Thakur   +2 more
semanticscholar   +1 more source

From powder to tablets: Investigation of residence time distributions in a continuous manufacturing process train as basis for continuous process verification.

European journal of pharmaceutics and biopharmaceutics, 2020
The essence of Continuous Manufacturing (CM) resides in the fact that continuous process units are directly connected to each other forming a continuous process train.
V. Pauli, P. Kleinebudde, M. Krumme
semanticscholar   +1 more source

Prediction of tablet weight variability in continuous manufacturing.

International journal of pharmaceutics, 2020
This paper provides a method for prediction of weight variability of tablets made in rotary tablet presses as a function of material attributes and processing parameters.
S. Razavi   +8 more
semanticscholar   +1 more source

Process analytical technology for continuous manufacturing tableting processing: A case study

Journal of Pharmaceutical and Biomedical Analysis, 2019
&NA; The use of Near Infrared Spectroscopy (NIRS) as a fast and non‐destructive technique was employed for the control and monitoring of the tableting step during a continuous manufacturing process.
V. Pauli   +7 more
semanticscholar   +1 more source

E-factor analysis of a pilot plant for end-to-end integrated continuous manufacturing (ICM) of pharmaceuticals

, 2020
Most drugs are still manufactured by time-intensive and cost-inefficient batch processes; however, the pharmaceutical industry is undergoing a transition to continuous processes to benefit from the reduced lead time, cost, and footprint and improved ...
Chuntian Hu   +14 more
semanticscholar   +1 more source

Continuous manufacturing process monitoring of pharmaceutical solid dosage form: A case study.

Journal of Pharmaceutical and Biomedical Analysis, 2019
Continuous Manufacturing (CM) of pharmaceutical drug products is a rather new approach within the pharmaceutical industry. In the presented paper, a GMP continuous wet granulation line used for clinical production of solid dosage forms was investigated ...
Y. Roggo   +7 more
semanticscholar   +1 more source

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