Pharmaceutical Technology-10-02-2019

The new Fourier-Transform Infrared (FT-IR) spectrometer from Protagen Protein Services is used for advanced structural characterization of protein-based biologics and monitoring of vibrational modes of the amide bonds within a protein while in its native state and formulation matrix.

The new Nexera Prep Series Preparative Purification Liquid Chromatograph by Shimadzu improves prep processes for extraction of functional and impurity components, purification of target compounds in the pharmaceutical, chemical, and food industries, and productivity via flexible scalability and preparative workflow.

Airnet II Stainless Steel by Particle Measuring Systems (PMS) aids in cleanroom monitoring in high dust and moisture environments.

VersaMix Multi-Shaft Mixers from Ross utilize a proprietary powder induction feature for charging of thickeners to produce high-quality gels, creams, and pastes.

Limited guidance and numerous challenges create confusion about the scope and timing of stability testing for drugs in development.

Climbing out of a reputation hole starts with adopting a quality culture.

With no plausibly approvable deal on the table in the UK government at the moment, it is possible that Brexit could be extended even further.

A new European Commission is likely, with the support of a new European Parliament, to give a higher profile to healthcare and pharmaceutical matters during its five years in office.

Falsified documents and manipulated test results prompt warnings and investigations.

In this article, experts discuss the fundamentals of dissolution testing and highlight the challenges that are surfacing as a result of the increasing numbers of poorly soluble molecules entering the development pipeline.

Lipid-based formulations provide a versatile solution to bioavailability issues, but a multi-disciplinary approach is needed to overcome limitations with poorly soluble compounds.

As the development pipeline becomes more saturated with complex molecules and patient experience becomes more important, developers are looking to outsourcing partners to provide more specialized expertise and solutions.

Changing regulatory guidance on generic topical products is expected to lead to an increase in the number of market approvals in the near future.

Data supporting the quality and safety of product must meet the ALCOA+ elements in order to avoid regulatory citations for data integrity issues, says Susan J. Schniepp, executive vice-president of post-approval pharma and distinguished fellow, Regulatory Compliance Associates.

Establishing OEL data and ensuring appropriate engineering controls are crucial aspects of safe handling.

Advances in fill/finish for parenteral packaging address demands for efficiency and product safety.

Automated, electronic systems for raw materials tracking improve efficiency and prevent mistakes in biopharma manufacturing.

Using the central limit theorem concerning the distribution of means allows one to justify the assumption of the normal distribution.

Production and process controls, organization and personnel were the top problems found, while packaging and labelling citations increased in 2017 and 2018.

Research into peginterferon alfa-2b’s degradation pathways suggest that drug substance be immediately and continuously converted to drug product when the material is in liquid form.

Click the title above to open the Pharmaceutical Technology October 2019 issue in an interactive PDF format.

Software systems can help validate pharmaceutical manufacturing and steer the most appropriate design of processes in the right direction.

Industry experts discuss the challenges and regulations of setting up a CGMP-compliant stability testing program.