Solid Dose Featured Articles
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All You Need To Know About Contamination Control Strategies, Part 1
5/12/2023
In the first of this two-part series, microbiology and contamination control specialists Vanessa Figueroa, Rebecca Brewer, and Greg Gibb, Ph.D., discuss best practices in developing contamination control strategies through the lens of the newly formalized provisions in the EU GMP Annex I, Manufacture of Sterile Medicinal Products.
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5 Misconceptions About Data Integrity In Pharmaceutical And Device Development & Operations
9/15/2021
Data integrity (DI) issues in pharma and medical devices have always been there, but in my experience as a consultant, these issues have increased in frequency more recently, thus moving them to the forefront. In this article, I explain five misconceptions about data integrity in our industry.
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Containment Solutions For Safe Handling Of HPAPI Chemical Synthesis
6/4/2019
With high potency active pharmaceutical ingredients (HPAPIs) comes a heightened awareness of this requirement and the added burden of a higher level of regulatory oversight.
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How Can You Achieve Economic Compaction Of Your Raw Materials?
12/19/2017
In tablet manufacturing, the traditional use of a batch-based wet granulation process presents several issues. An alternative to this is dry granulation by roller compaction. However, to appreciate how roller compaction can benefit manufacturing capacity and efficiency, it is important to first understand the functionality and capability of this technology.
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How To Utilize Zeta Potential To Stabilize Pharmaceutical Suspensions
10/17/2017
As an indicator of the suspension quality of various pharmaceutical products, using the measurement of zeta potential to yield the best products is of primary importance during product development.
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Outsourcing Solid Dose Manufacturing Trends In 2014
3/3/2014
In 2014, the contract manufacturing market for solid dosage forms is anticipated to be $19.6B, representing 58% of the total CMO market value of $33.7B. While the market value percentage for solid dose has been drifting downward — likely related to the shift towards biologics, which are more expensive to develop and manufacture — the propensity to outsource oral solid dosage forms continues to grow modestly.
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Contract Manufacturing In China
12/4/2012
The outsourcing of pharmaceutical manufacturing is growing most rapidly in Asia. Recently, PriceWaterhouseCoopers named China as the most attractive Asian country for outsourcing. At present, more than 100 drug manufacturing sites in China are manufacturing API or finished products for approved branded and generic drugs. By Oliver Mueller & Clifford Mintz, PhD
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The Benefits Of Contract Manufacturing
10/25/2012
Contract manufacturing organizations (CMOs) offer a wide array of manufacturing services to the pharmaceutical and biotechnology industries. These services can range from production of small quantities of materials for R&D purposes, larger amounts for clinical study usage and ultimately full-scale production for commercial purposes. The global contract manufacturing market primarily includes solid and liquid dosage forms and injectables.
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Accelerated Drug Development: The Promise Is In The Process
3/21/2012
In 1993, the FDA issued the call to the pharmaceutical industry to streamline the drug development process from discovery to First In Man. By Jan-Olav Henck, Ph.D., Chief Scientific Officer, Aptuit LLC
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Saudi Arabia Emerges As Pharma Manufacturing Hot Spot
2/12/2012
The World Bank/International Financial Corporation’s Doing Business report ranked the Kingdom of Saudi Arabia 12th in the world out of 183 economies for ease of doing business in 2011 — up from 67th in 2005. By Sara Gambrill, Life Science Leader magazine