Ron Scarboro, Azurity Pharmaceuticals, explains how cross-functional development, disciplined reformulation, and post-approval metrics can help proven medicines work in everyday use.
|Articles|November 13, 2014
Novasep and Nilsan Nishotech to Install Continuous Chromatography System at Laurus Labs
Novasep, a supplier of life-sciences manufacturing solutions, and its partner Nilsan Nishotech Systems, a process engineering specialist in India, announced the commissioning of a continuous chromatography Varicol system at Laurus Labs, an API manufacturer based in India.
Advertisement
Novasep, a supplier of life-sciences manufacturing solutions, and its partner Nilsan Nishotech Systems, a process engineering specialist in India, announced the commissioning of a continuous chromatography Varicol system at Laurus Labs, an API manufacturer based in India.
This is the first time Laurus Labs will use a continuous chromatography system at multi-ton scale to obtain high productivity and cost-efficient chiral molecule separation.
Varicol continuous chromatography is used to separate enantiomers from racemic mixtures. A key feature is the solvent recycling unit associated with the chromatography system enabling the process to exhibit low solvent consumption (more than 99.9% solvent recovery).
According to the press release, Novasep’s Varicol is capable of achieving separation of 500 kg per day in Laurus Labs’ production of API. Prior to the installation, Novasep conducted a feasibility study at its R&D laboratory in Pompey, France, to evaluate the continuous process on a small-scale.
Source:
Advertisement
Related to this article
The FDA approves oral pritelivir for drug-resistant herpes sores in immunocompromised patients; what it means for antiviral development and manufacturing.
This week, drug formulation and manufacturing experts showcased their knowledge, and companies exhibited their products, at CPHI Milan.
FDA approves Teva’s Weltruza, a once-monthly subcutaneous olanzapine for schizophrenia whose copolymer depot eliminates post-injection monitoring.
Equivalence test using two one-sided tests are widely used for demonstrating the comparability of treatment effects in different research fields. The method described in the manuscript aims to use simulations in Microsoft Excel to compute power for 2 one-sided tests for two groups with unequal variances.
Richard Jaenisch examines whether FDA's NAM pathway truly shortens drug pipelines or just shifts the evidentiary burden elsewhere.
Susan J. Schniepp, distinguished fellow with Nelson Labs, and Siegfried Schmitt, PhD, vice president, Technical, with Parexel, clear up some of the confusion about what does and does not need to be complied with regarding standards set by international pharmacopoeias.
Mitigating nitrosamine risk requires assessing each product individually, says Bram Baert, Global Head of Regulatory Affairs at Capsugel, and Sandrine Picco, Senior Analytical Specialist on Capsugel's Innovaform Accelerator Team, in this interview with PharmTech.
Advertisement
Advertisement
Trending on Pharmaceutical Technology
1
Pritelivir Shifts Resistant Herpes Care from Intravenous to Oral
2
What the Olanzapine Depot Approval Means for CMC Teams
3
PharmTech AI Pulse Check: Availability Bias Threatens AI Regulatory Reviews
4
Complying with International Pharmacopoeias
5