Over two-thirds of recombinant biopharmaceuticals, including more than 85% of monoclonal antibody drugs, are manufactured using Chinese Hamster Ovary (CHO) cell lines. Residual Host Cell Protein (HCP) impurities derived from these cells can compromise the stability, efficacy and safety of the therapeutic product. Regulatory authorities such as the FDA therefore require manufacturers to monitor and …

A column is the heart of any chromatographic separation. Taking good care of that column will help ensure that your investment has the longest possible lifetime and will be ready for your samples. It isn’t hard to ensure your LC and SFC columns are used, stored, and cleaned correctly, but mistakes can be costly. Your …

In today’s highly digitized world, data integrity and computer system validation (CSV) compliance is of paramount importance within the pharmaceutical manufacturing industry. It is necessary to ensure the safety, efficacy, and quality of drugs, and to protect public health. Regulators conduct regular inspections of drug manufacturing facilities to ensure manufacturers are GMP compliant. In the …

Whether consumers are supplementing their diet with vitamins, taking a daily aspirin, or using an inhaler to relive asthma, they will likely presume the medicines they are prescribed are safe, effective, and of the highest quality. This assumption is, in most cases, correct – the pharmaceutical industry is one of the most highly regulated in …

Of the 95 warning letters issued by the FDA in 2018 – 54 of them involved data integrity. As with any industry, success depends on following quality standards throughout all aspects of work. For the pharma cycle, it’s extremely vital because drugs that make it to market are expected to be trustworthy. This requires an …

Consumers expect that the medicines they need are guaranteed to be effective and safe. This means that throughout the entire manufacturing process, as well as during research and development, all standards of quality are being met or exceeded. While most people are probably unaware of all the ingredients that make up their medicine, pharmaceutical manufacturers …

Impurities in drug substances and drug products provide no therapeutic benefit. Heavy metals – arsenic, cadmium, mercury, and lead, for example – are not generally useful in pharmaceutical production… but are still present as impurities. Controlling these substances is not only imperative to the health of patients, but also to the integrity of drug manufacturers. …

While harmonization efforts and the leadership of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) and World Health Organization (WHO) have proven helpful in minimizing the prior variance and complexity in the drug development pathway for GMP-regulated labs, their interactions with individual pharmacopoeial monographs, as well as regulatory agencies, …

Quality and Compliance – Where You Need Them Most Pharmaceutical labs consider dissolution testing to be one of the critical steps in the drug development process. And it makes its impact at almost every step of the journey, from early product development to late-stage quality control. Dissolution testing helps labs control key variables in the …

When it comes to your batch release – whether it’s a drug’s introduction to the market or the return of an existing product – a seamless rollout can save your reputation and minimize overhead costs. Ensuring that you follow standard procedures and protocols is essential in all stages of the process to guarantee success. We’ve …