New requirements for control of elemental impurities went into effect at the beginning of 2018, replacing the longstanding requirements for heavy metals. Elemental impurities guidances — International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Q3D, U.S. Pharmacopeia (USP) General Chapter <232>, European Pharmacopeia (EP) 5.20 — are based on modern safety considerations specific to the elements identified.
Biopharma executives have warned they need more biologics development and manufacturing capacities, particularly in North America. They haven’t been howling at the moon. Four announcements – within two days of each other – offer a sign of relief. And Amgen has provided Outsourced Pharma with its first public estimate of costs for one of those facilities.
During my visit to Thailand, I was privy, not only to the particularly innovative research goals being pursued, but also to a number of challenges the country has recognized and hopes to address within the next few years to encourage a stronger, more diverse industry.
A few weeks ago, I was invited by the Thailand Board of Investment to attend a media trip to learn about the country’s budding life sciences industry. Entering Thailand, a country in which the government is pushing more investment and education in the sciences, was even more striking and meaningful to me given the current scientific climate in the U.S.
In the spirit of this list-making season, I compiled what I thought were the five most important biosimilar-related triumphs in the past year. Many of these events were widely covered by the media and will play an influential role in how the biosimilar industry unfolds through 2017 and beyond.
Pfizer's Bernie Huyghe and ADC Therapeutics' Michael Mulkerrin get bushwhacked with this question in a public forum. Their open replies will help each one of you to your own personal assessment. Be prepared for some soul searching.
New requirements for control of elemental impurities went into effect at the beginning of 2018, replacing the longstanding requirements for heavy metals. Elemental impurities guidances — International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Q3D, U.S. Pharmacopeia (USP) General Chapter <232>, European Pharmacopeia (EP) 5.20 — are based on modern safety considerations specific to the elements identified.
Using a risk management tool such as preliminary hazard analysis, a periodic review frequency can be identified and applied to qualified equipment. This will enable a timely review of the equipment by means of pertinent data such as manufacturing performance trend data, change history, and/or deviation history.
This is the first in a five-part article series, Identifying And Resolving Errors, Defects, And Problems Within Your Organization. This article will enhance your understanding and prime you for visual detection of real trends in your organization by looking at a couple of examples. (You will understand the relationship between this picture and your quest for the quantitative truth by the end of this article.)
When weighing the operational and product constraints — batch size, container throughput, cost per unit, equipment utilization, facility footprint, cost per square foot, etc. — it is important to consider all of the options available to provide the most effective processing approach for the product manufacturer and, importantly, the best quality product for patients.
When looking at most job descriptions in GMP companies, they now require a college degree. This leads to the question: Are we overvaluing educational degrees and undervaluing experience in our hiring practices and position expectations?
The high-shear rotor/stator mixer (HSM), once relegated to a relatively narrow niche of mixing applications, has become a mainstay in many applications in the chemical process industries. The ability to apply intense shear and shorten mixing cycles gives these mixers broad appeal for applications that require immiscible fluids to be formulated into emulsions, or agglomerated powders to be dispersed into a liquid medium.
Excipients have a much larger influence on final product performance than the term “inactive ingredient” suggests. Choosing the right excipients is a key determinant of the quality.
Dye ingress leak testing and vacuum decay are the most common methods used for leak testing blister packages.
Companies are reevaluating mixing processes, looking for ways to lower cost, boost production capacity, and improve quality. This article will explain how high shear mixing can help achieve these goals.
Whether biopharmaceutical companies have one candidate or 100, the directive is clear: moving quickly into FIH testing is essential. But, how?
When selecting a bioreactor, It is important that this core technology is carefully chosen, specified, designed, and supported, both now and in the future.
The use of aqueous cleaning in medical device manufacturing can provide numerous benefits in terms of efficacy, minimal surface contact and reduced residue potential, and easier cleaning validation.
