14 March Seminars

This presentation will broadly cover:

- Sharing audit observations (Indian API companies)
- Provide an insight into audit areas to focus on
- Tips on successfully conducting audits
- Focus on particular GMP areas such as transportation

Delivery of medicinal products through the lungs, via capsule based Dry Powder Inhaler devices represent one of the most rapidly expanding fields in pulmonary drug delivery. The precise filling of capsules with doses in the milligram-range needed for inhalation application relies on a well understood filling process. Among the several low-dose capsule filling systems currently available, the dosator principle plays an important role. One of the greatest challenges for successfully manufacturing high-quality low-dose inhalation products is dose uniformity. During a dosing step a combination of various stresses between the powder and the equipment material, results in more or less stable plugs which can be lifted by the nozzle to be filled into a capsule. The powder is kept in the dosator nozzle because of the formation of a stable arch at the outlet, which is dependent on powder characteristics and the vertical stresses which are transmitted through the powder bed. In order to understand the interplay between filling process and filling material a combinational approach, which comprises an in-depth analysis of the process based on experimental and in silico simulation studies was used: 1) To experimentally investigate the effect of different material properties and process parameters on the quality of the final product using a lab-scale, capsule filler; 2) In silico simulations via the Discrete Element Method to support experimentally obtained data and to be able to "look inside" the dosator nozzle. Modelling and simulation studies of the dosator capsule-filling process are rare and a deeper mechanistic understanding of the process is required. With this combined approach, process understanding and mechanistic modelling & simulation a systematic understanding, thus a further step towards a scientific qualification of dosator nozzles capsule filling can be achieved and will help improving the filling performance of challenging powders for DPI applications.

Both the USP and EP implemented changes to the requirements for elemental impurities testing during the winter of 2017/2018. The changes were implemented based on the publication of ICH Q3D regulations in December 2014.

These changes have now been in place for around 100 days so are still in the early stages of being part of the regulations, but this major change has still had a significant impact on the nature of pharmacopeial testing.

The removal of the use of the wet chemistry heavy metals test, to be replaced by specific elemental testing has been the most significant change to the pharmacopeias. Elemental testing that was historically included in monographs has, for the time being, been retained. Compliance with the regulations can seem a burdensome, but through a risk assessment process this burden can potentially be reduced.

In this presentation, a brief background of these regulations will be discussed, along with the impact of the changes on the nature of control of elemental impurities within the pharmacopeias and how this new approach is starting to become incorporated into pharmaceutical control as well as covering some examples of elemental testing that has been retained within the monographs.

The utility of mini-tablet dosage forms for paediatric administration is becoming more commonplace. However, the manufacture of these dosage forms is not without its challenges and this presentation explores some of the solutions and strategies put in place to address these issues. Furthermore, a range of finished dosage form presentations are discussed and case studies on clinical supply formulations and commercial product are used to illustrate the performance and opportunities for these types of dosage forms.

How do world class firms set the culture, communication strategy and management style to ensure GMP is followed even when Supervisors are not watching? How can we use studies of human behaviour to reduce the risk of error, non-compliance and poor decision making? How can we simplify the whole process of GMP compliance.

GSK Vaccines Global Regulatory Affairs executes over 1000 submissions each year with a team of more than 400 experts. Obtaining and providing end-to-end demand visibility is more than ever a critical success factor for on time delivery and optimal use of critical resources.
In this case study we will share an innovative approach based on the Binocs Cloud platform for resource planning (discover-binocs.com). We’ll shortly demonstrate the platform, discuss our implementation approach and share our KPI improvements.

Given the growth of the Biopharma sector and the number of Biosimilars making it to market one aspect of these products that still causes concerns is the risk of protein immunogenicity. There are several factors that play a role in immunogenicity, a key factor is the presence of aggregates, which when found in products can increase the risk of an immune response. Aggregates can be formed under a number of conditions and at various stages of the production, shipment or during delivery to the patient. Therefore, understanding and characterizing these macromolecules is an important aspect of bioanalytical analysis and patient safety.

This presentation will aim to provide a "how-to-guide" to aid your macromolecule characterisation efforts, and illustrate why it is critical to have a good understanding of the techniques when interpreting the results.

The inherently complex nature of a globular proteins mean that an overreliance on in silico modelling is a highly risky, yet surprisingly common, approach to take during early formulation development activities. Light scattering is highly sensitive to changes in the apparent size of a molecule; making it ideally placed for proteins and other macromolecule analysis. Experiments can be designed in such a way that allow for the development of robust formulations that are resistant to common causes of batch failure; such as agglomeration and sensitivity to temperature changes.