Archives: Articles

DAY 1 – September 24   Keynote: Oliver Kappe – University of Graz   

Green chemistry is a powerful lever to accelerate the decarbonization of the industry, and because it is not only about inventing new molecules but rethinking an industrial ecosystem, it is risky, complex, and highly rewarding to the winners.
In this article, we aim to review what is fueling the green chemistry rise, what challenges innovators will need to master, and to suggest some directions to scale and success.

Electrochemical energy storage technologies (Lithium & Sodium-ion, Lithium-Sulfur batteries) require a range of highly engineered carbon materials as active materials or conductive additives. With the overal demand for batteries expected at 5 TWh in 2030 (1), this article aims to give an overview on the challenge of sourcing these materials from sustainable processes as well as potential solutions. One solution in particular is to utilise CO2 as a feedstock to create valuable carbon materials while avoiding greenhouse gas emissions. The utilisation of CO2 is assessed from both technical and regulatory perspective, showcasing that a true carbon sink can be found in these materials.

In this article, we wish to highlight the evolution of drug delivery technologies alongside generations of therapeutics, from small molecules to proteins and peptides, to nucleic acids and, most recently, to live-cell therapies.
We will first introduce the context and therapeutic applications of polymeric based drug delivery systems. We will then describe the advances of delivery approaches, with a focus on biodegradable and bio-absorbable polymers, bio-related copolymers and dendrimers.
We will illustrate with two case studies based on water-soluble synthetic polymers that have emerged as essential tools for many biomedical applications. Backed with our experience and expertise in polymer-based chemistry and manufacturing, these polymers are poised to further advance in the realm of biomedicine.

Ever since the publication of the 2006 IPEC-PQG GMP Guide for pharmaceutical excipients, suppliers have needed to demonstrate they have applied those GMPs. Thus, was born, EXCiPACT, the GMP/GDP excipient certification scheme which shares not only the certificates but also the audit reports. The way EXCiPACT can be implemented by excipient suppliers and used by drug product manufacturers is explained, with the benefits both parties can obtain. Recent publication by the regulatory authorities has clarified how EXCiPACT and other 3rd party audit schemes can be used is also highlighted.

Small biotech companies are driving the development of many novel drugs. These companies often lack the resources of their big pharma counterparts.
The strategic use of pharmaceutical consultants can help to mitigate risks, ensure compliance, and accelerate the overall drug development process. In this work, recommendations for how to select consultants and establish consulting agreements are provided. Suggestions for areas where consultants may be particularly impactful during drug development are also given.

Pharmaceutical CDMOs face a complex regulatory landscape, juggling compliance with multiple international standards. Meeting these requirements means aligning manufacturing processes with cGMP guidelines, handling regulatory filings across multiple regions, and adhering to strict safety and environmental protocols. To ensure compliance, CDMOs need a strong quality management system with vigilant oversight. CDMOs must also proactively identify and mitigate risks and continue to improve processes to match regulatory changes and industry trends. A good framework for CDMOs to build the strength of their quality systems is to consider the maturity of their quality management practices. By assessing five key practice areas of quality management maturity, CDMOs can identify opportunities to move their organizations from mere compliance to operational excellence.

The growing complexity of next-generation biologics is exposing the limitations of traditional downstream processing (DSP) technologies. This article explores the critical need for innovation in purification media to meet the demands of new biological modalities such as drug conjugates, viral vectors, nucleic acid therapeutics, and others. We examine performance gaps in current DSP platforms, highlight areas where technologies have delivered impact or failed, and highlight the importance of designing new solutions that are compatible with regulatory requirements, sustainability, and rapid integration across development stages. We argue that purification media must evolve from a passive consumable to a strategic enabler of biomanufacturing agility and success.

Scaling up flow processes in the fine chemical and pharmaceutical industries is underpinned by the integration of chemical engineering and process chemistry. Continuous processing is vital for achieving efficiency, productivity, and sustainability within chemical manufacture and is aligned with good corporate social responsibility. At Almac Sciences (Almac), the implementation of scalable flow processes has augmented the way chemical processes are performed, ensuring that the transition from laboratory to industrial scale is seamless and effective across their sites in Ireland. This article explores the strategic implementation of flow chemistry, highlighting its role in innovation, cost reduction, and environmental impact mitigation, with case studies in high-pressure hydrogenation and low-temperature formylation.