All our Blog posts can be found here, listed in chronological order beginning with the most recent post. To access blogs on specific topics, use the links below.

Unlocking the Potential: The Power of Drug Repurposing in Modern Medicine

Drug development is a complex, expensive, and multistage process which could take 10 to 15 years to bring a new molecule from discovery to commercialization. Drug repurposing, also known as drug repositioning paves an alternate path for drug development which involves identifying new therapeutic indications or uses for the existing molecules that could have been initially approved for or have clinically failed in a different indication. The success rate for new drugs to reach the market is approximately only 10% whereas about 30% of repurposed drugs get regulatory approval.

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Formulation Strategies for Large Molecule Drug Products

Large molecule drug products produce highly effective medicines, but formulation can be challenging because of their complexity, sensitivity, and potential for instability. It is crucial that formulation strategies ensure their bioavailability and efficacy to develop new and successful products.

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Ensuring Aseptic Technique: Use of Isolators

By: Deb Quick, Ph.D. Senior Consultant Everyone knows that good aseptic technique is crucial when handling biological products, particularly in fill and finish operations. But for cellular therapies, good aseptic technique is essential throughout the entire process to...

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What is a process control strategy and why is it important?

By Maria Wik, MS VP, CMC Development The ICH Q10 definition for a Control Strategy is: “A planned set of controls, derived from current product and process understanding, that assures process performance and product quality.” Understanding the essence of a process...

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Three Characteristics of a Rock Star QC Partner

Biomedical startups experience a failure rate of 90% per year for various reasons, including flawed financial strategies, inexperienced management, subpar science, poor timing, and an aversion to risk. Another significant factor is quality control issues stemming from poor team selection and inadequate time and resources, which also applies to quality control (QC) partners. However, there are three key characteristics that reliable QC professionals bring to the table in a drug development organization’s process of creating new pharmaceutical products. These characteristics significantly improve the odds of regulatory approvals.

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3 Critical Keys to Expediting CMC Development

Certain key strategies are imperative for establishing effective quality control (QC) systems in the development of new pharmaceuticals. The “Key 3” are implementing a QC process control strategy, creating a Standard Operating Procedure (SOP) manual, and partnering with experts.

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What Does Syner-G’s Technical and Quality Assurance Team Do?

One thing that we on the Technical and Quality Assurance (QA) QA team share with every employee throughout Syner-G is intelligence, passion, and unwavering commitment to making a difference. While every department within the organization brings unique knowledge and skill sets to problem-solving, our team is specifically responsible for transforming concepts, ideas, and dreams into tangible products that have the power to transform lives.

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