For many years, the pharmaceutical industry meant “small (usually synthetic) molecules” mixed with various non-active materials and put into capsules or, in the old days, rolled into pills or pressed into tablets. While synthesizing the APIs (active pharmaceutical ingredients), formulating the dosage forms, and analyzing the materials at every step of the life cycle was not always trivial, it was relatively straightforward.
One of pharma’s greatest foibles as an industry has been the penchant to focus on the wrong things. We saw this with process analytical technology (PAT), where we focused on the design and implementation of the technology and ignored the impact of foundational material characterization and supplier control. Pharma 4.0 has the potential to fall into the same trap.
This article will share recent analysis of price increases within the healthcare sector in an effort to understand the growth of healthcare expenditures and pharmaceutical prices over time.
The FDA’s Population Pharmacokinetics Guidance for Industry draft calls for sponsors of new drug and biologics license applications to apply population PK analysis. This column covers the implications for drug and device manufacturers.
Following a trial in the District Court of New Jersey, Sandoz has been barred from marketing a biosimilar version of Amgen’s Enbrel product. Due to the scarcity of biologics patent case rulings, this case provides an interesting precedent for how future decisions may treat biologics patent issues.
This is the second part of a two-part article counting down the FDA’s top 10 most-common drug GMP inspection citations for the agency’s 2018 fiscal year (FY2018).
A recent decision by the U.S. Court of Appeals for the Federal Circuit has indicated that pharmaceutical makers with patent protection are unlikely to receive any compensation from the government for the loss of their patents during inter partes review (IPR) decisions by the Patent Trial and Appeal Board (PTAB).
With all the attention on the costs of pharmaceutical products, there is an upcoming regulatory “dead zone” that will potentially delay market entry of certain insulin products, adversely impacting insulin prices for consumers and payors. A recent Senate bill has been proposed to address this regulatory anomaly. Industry players should monitor this bill and other efforts to address the insulin dead zone, given how critical this product is to so many people.
The transfer of a monoclonal antibody production process between scales, often referred to as scale-up or scale-down, is a difficult task. This study reviews moving a monoclonal antibody production process from a microscale bioreactor to the Xcellerex XDR single-use platform.
Surface plasmon resonance (SPR) assays are used across the life cycle of a biopharmaceutical, from target identification, through CQA determination, development, and on-going quality control. This article focuses on concentration assays associated with late-stage development and biotherapeutic drug chemical manufacturing and control.
An organized effort across biopharma, including drug substance manufacturers and suppliers, is needed to address and meet the needs of industry regarding raw material quality and consistency.
Learn what challenges exist when developing biologic drugs to be efficacious but safe and how novel analytical techniques, like surface plasmon resonance, can help circumvent these issues and optimize development.
A single-step downstream process using protein A chromatography to purify a bispecific antibody (BsAb) in early screening has been successfully developed to replace an existing-three step process.
Protein Sciences learned several valuable lessons during the development and final regulatory approval of its recombinant hemagglutinin (rHA) influenza vaccine, Flublok.