Modernizing pharmaceutical manufacturing: from batch to continuous production

SL Lee, TF O'Connor, X Yang, CN Cruz… - Journal of …, 2015 - Springer
Abstract The Food and Drug Administration (FDA) regulates pharmaceutical drug products
to ensure a continuous supply of high-quality drugs in the USA. Continuous processing has …

[HTML][HTML] The future of pharmaceutical manufacturing sciences

J Rantanen, J Khinast - Journal of pharmaceutical sciences, 2015 - Elsevier
The entire pharmaceutical sector is in an urgent need of both innovative technological
solutions and fundamental scientific work, enabling the production of highly engineered …

Assessment of recent process analytical technology (PAT) trends: a multiauthor review

LL Simon, H Pataki, G Marosi, F Meemken… - … Process Research & …, 2015 - ACS Publications
This multiauthor review article aims to bring readers up to date with some of the current
trends in the field of process analytical technology (PAT) by summarizing each aspect of the …

Process analytical technology in continuous manufacturing of a commercial pharmaceutical product

JM Vargas, S Nielsen, V Cárdenas, A Gonzalez… - International journal of …, 2018 - Elsevier
The implementation of process analytical technology and continuous manufacturing at an
FDA approved commercial manufacturing site is described. In this direct compaction process …

Recent advances in integrated process analytical techniques, modeling, and control strategies to enable continuous biomanufacturing of monoclonal antibodies

V Chopda, A Gyorgypal, O Yang… - Journal of Chemical …, 2022 - Wiley Online Library
Continuous bioprocessing is significantly changing the biological drugs (or biologics)
manufacturing landscape by potentially improving product quality, process stability, and …

Assessment of blend uniformity in a continuous tablet manufacturing process

NO Sierra-Vega, A Román-Ospino, J Scicolone… - International journal of …, 2019 - Elsevier
Blend uniformity was monitored throughout a continuous manufacturing (CM) process by
near infrared (NIR) spectroscopic measurements of flowing blends and compared to the …

A review of PAT strategies in secondary solid oral dosage manufacturing of small molecules

S Laske, A Paudel, O Scheibelhofer, S Sacher… - Journal of …, 2017 - Elsevier
Pharmaceutical solid oral dosage product manufacturing is a well-established, yet
revolutionizing area. To this end, process analytical technology (PAT) involves …

Implementation of an advanced hybrid MPC–PID control system using PAT tools into a direct compaction continuous pharmaceutical tablet manufacturing pilot plant

R Singh, A Sahay, KM Karry, F Muzzio… - International journal of …, 2014 - Elsevier
It is desirable for a pharmaceutical final dosage form to be manufactured through a quality
by design (QbD)-based approach rather than a quality by testing (QbT) approach. An …

A systematic framework for onsite design and implementation of a control system in a continuous tablet manufacturing process

R Singh, A Sahay, F Muzzio, M Ierapetritou… - Computers & chemical …, 2014 - Elsevier
A novel manufacturing strategy based on continuous processing integrated with
online/inline monitoring tools coupled with an advanced control system is highly desired for …

The application of an automated control strategy for an integrated continuous pharmaceutical pilot plant

R Lakerveld, B Benyahia, PL Heider… - … Process Research & …, 2015 - ACS Publications
Continuous manufacturing offers potential opportunities for the improved manufacturing of
pharmaceutical products. A key challenge is the development of an appropriate control …