Essential use of chemicals. An update
As known, essential use, was initially proposed by scientists and later referred to in
As known, essential use, was initially proposed by scientists and later referred to in
Pharmaceutical innovation requires efficient production of active pharmaceutical ingredients (APIs) and the synthesis often involves one or more catalytic steps. Optimizing the catalyst and reaction conditions will result in improved product purity, yield, and safety and such optimization is often accompanied by significant cost reduction. Many companies do not have such capabilities for catalyst screening and optimization studies in-house, due to a lack of continuous need or limited resources to maintain a high-tech laboratory with high throughput testing equipment. In such case, a (pharmaceutical) company has to rely on Contract Research Organizations (CROs) for their catalyst research. Selecting an expert CRO involves assessing their effective communication, scientific knowledge, high throughput infrastructure, unbiased services, flexibility, and quality control. Addressing potential challenges with clear communication, prompt issue resolution, aligned goals, and adaptability is critical. Collaborating with an experienced CRO can accelerate market entry, reduce production costs, and drive competitiveness in the rapidly evolving pharmaceutical industry.
As the pharmaceutical industry undergoes transformations driven by innovation, outsourcing plays a vital role in drug development. Contract development and manufacturing organizations (CDMOs) are no longer simply production capacity providers but have become integral collaborative partners. Choosing the right CDMO is crucial amid global trends and events. At Veranova, we work closely with our partners to manage industry demands with confidence. In this article, Ken Zrebiec, Veranova’s Senior VP of Manufacturing Operations, explores how pharma companies leverage specialized CDMO expertise to enhance development capabilities.
Pharmaceutical companies recognize that the absence of standardized data can hinder their agility and innovation. This is particularly applicable to in-flight data, as it travels between different software solutions. Max Kelleher, Chief Operating Officer at Generis and Remco Munnik, a Director at Iperion, a Deloitte business, offer practical guidance on mapping and managing operational data to enhance business operations.
Bormioli Pharma, global leader in pharmaceutical packaging and medical devices with a global presence
Waiting for regulators or software vendors to come up with the definitive rulebook for all future data reporting requirements is a bit like waiting for a tax office request to trigger accounts management. There will always be new compliance goals, but the real opportunity is about making good data work harder – something Life Sciences companies should be doing today. At Amplexor’s (now ArisGlobal) recent BE THE EXPERT 2023 global conference in June, Remco Munnik of Iperion – a Deloitte business, explored the broader process benefits and actionable insights that come within reach as soon as companies embrace the value of structured data in everything they do.
Bachem is leading specialist for drug substances, specializing in the development and manufacture
Continuous processing has been implemented for the intensification of manufacturing in many industries, including small molecule drug production. However, adoption of continuous processing for biopharmaceutical manufacturing has been occurring at a relative slow rate. Biophorum has been active in understanding the biomanufacturing landscape to help promote and establish implementation of continuous manufacturing technologies through a cross-industry team of end-users, suppliers and integrators. This team has identified barriers, provided innovative solutions, and collaborated with industry stakeholders to develop a consensus approach in a number of areas such as optimizing buffer management bottlenecks, defining process control strategies, and developing templates for critical process parameter evaluation. Through these activities, significant progress has been made in enabling faster implementation of continuous processes in a GMP environment, reducing time-to-market, and lowering manufacturing costs. This article provides an overview of this cross industry team’s accomplishments and highlights the impact of their efforts in driving the adoption of continuous biomanufacturing across the pharmaceutical industry.
mRNA vaccine is the newest type of vaccine available to the public and has great prospects in terms of speed from research to market. In manufacturing, some barriers observed during Covid can already be lifted up such as (A) a slow transition from research to commercialisation, (B) unequal access to vaccines across countries and (C) inadequate supply of raw materials. Solutions have already been found for (A) a quicker shift from benchwork to commercialisation with a manufacturing process based on repeat-batch production of in vitro transcription (IVT), (B) technology that is small, straightforward to use, modular and transportable to diverse locations and (C) increased number of suppliers for critical raw materials, which are reputable for reliable and predictable deliveries. RNA production with Ntensify™ starts with DNA templates which are first transcribed into RNAs and then purified, ready for encapsulation. In this process, the reaction volume of the in vitro transcription (IVT) is fixed to 20 mL. Large-scale manufacturing occurs by 20 mL increment: i.e. repeat-batch production, with the benefit of an already optimal ratio for reagents (a process co-developed with our partner eTheRNA), which avoids dedicating time to optimisation when entering production. With both high yields and low impurities RNAs, purification can be simplified to a single step. To demonstrate that our approach in 20 mL is successful, several constructs were tested using this process. Their sequence length ranges from 1999 and 4060 ribonucleotides. mRNA reaction yield is on average 5.1 mg/mL. Analysis of the data shows that all batches met the specification limits, where defined.
Indena, the leading company dedicated to the identification, development and production of high