Technology & Innovation
Bioprocess Development: New Advances in Drug Product Process Development & Validation
- Recent Advances in Bioprocess Development & Manufacturing
- Approaches in developing drug product
- Incorporating new tools into Drug Product development
- Integrated bioprocess development for the future
Thanks to a combination of emerging technologies such as high producer cell lines, of single use disposable technologies and to continuous bioprocess, most of bioprocess bottlenecks have been overcome. Development of a biological drug product meanwhile is still mainly an empirical stepwise approach. It starts by a broad preformulation screening of different parameters such as buffering system, pH, isotonic agents and further stabilisers (detergents, amino acids, etc). Following the prescreening, an optimization step is run to preselect candidates to put on technical stability under intended storage conditions as well as under thermal stress.
While such development is seen as a well-established approach in developing biological drug products, it is however time and resources consuming, often putting drug product in the critical path.
New alternatives, based on prior knowledge gathered over the last 20 years in developing recombinant proteins and peptides, are emerging. Indeed taking advantage on a better understanding of the degradation pathways and on critical parameters, several simulation models have been developed. The models to determine the effects from thermal stress experiments and the downscale simulation tools are becoming very promising in predicting shelf-life and therefore accelerating biotherapeutics development. Integrated drug product development approach will be presented and discussed.
Global Head Drug Product Development, BTDM-BPD
Technology & Innovation
Formulating for Microneedle Delivery
Exploring the mechanisms available, including hollow, solid, dissolving and hydrogel-forming microneedles
Assessing the delivery of therapeutically relevant concentrations of drugs
Formulating to increase optimisation of Microneedle delivery
Bridging drug design with drug delivery science to create a larger pool of suitable entities for transdermal delivery
In addition to reviewing traditional microneedle technologies, this presentation describes production of unique microneedle arrays prepared from crosslinked poly(methylvinylether-co-maleic acid) which contain no drug themselves. Instead, they rapidly take up skin interstitial fluid upon skin insertion to form continuous, unblockable, hydrogel conduits from attached patch-type drug reservoirs to the dermal microcirculation. Importantly, such microneedles, which can be fabricated in a wide range of patch sizes and microneedle geometries, can be easily sterilised, resist hole closure while in place and are removed completely intact from the skin. Delivery of macromolecules is no longer limited to what can be loaded into the microneedles themselves and transdermal drug delivery is now controlled by the crosslink density of the hydrogel system rather than the stratum corneum, while modulated delivery and the potential for minimally-invasive extraction of skin interstitial fluid for monitoring purposes are also unique features. This technology has the potential to overcome the limitations of conventional microneedle designs and greatly increase the range of type of drug deliverable transdermally, with ensuing benefits for industry, healthcare providers and, ultimately, patients.
Prof. Ryan Donnelly
Chair in Pharmaceutical Technology
Queen’s University Belfast
Biologics – Optimising Drug Formulations
Long-lasting Parenteral Formulations for Peptides
• Half-life extension approaches
• Prodrug depots with cleavable linkers
• Encapsulation approaches
• Devices One way to improve patient compliance consists in reducing the number of injections defined in the therapeutic plan.In the past years, sales for GLP-1 receptor agonists showed a clear trend towards weekly dosed drugs. This presentation will highlight different approaches and technologies used in developing long-lasting peptide formulations. Additionally, the device strategy and its impact on the peptide formulation will be also discussed at the end of the presentation.
Head of Laboratory