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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.

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.

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...

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.

Personalized medicine is truly that. Based on an individual's unique genetic profile, it’s used to make precise decisions according to that person’s biologically predetermined factors, and guides the optimum approach to disease prevention, diagnosis, and treatment. It...

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.

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.

How AI and ML can facilitate quality improvements in biopharma Artificial Intelligence (AI) and Machine Learning (ML) are often confused, but they are fundamentally different. AI comprises pre-built products that use established patterns for recognition and...