MP-B Seminars

The chemical and pharmaceuticals industry is one of the United Kingdom’s largest industries and the nation’s second largest export commodity.

Many chemical and pharmaceutical supply chain stakeholders are taking responsibility for finding solutions and driving initiatives that help address, improve, and resolve industry challenges and the CBA continues to lead and facilitate collaboration, to use the challenges of recent years as catalysts for positive change, and to build and maintain momentum to ensure a sustainable future.

CBA’s new People & Skills Hub (P&SH) is addressing the need for a talented and well-motivated workforce that possesses a ‘can do’ attitude and the relevant skills, knowledge, and experience. We have introduced Generation STEAM which fully recognises the importance of STEM but also

recognises the ever-increasing need for creativity in today world, opening our industry to a wider

workforce in order to ensure people at all stages of their careers are empowered to build bright futures in the industry, attracting a wide range of talent and regardless of their background.

The chemical and pharmaceutical industry has a key and leading role to play in decarbonisation, which means that understanding carbon and other greenhouse gases and their role in climate change has become increasingly vital for all sector stakeholders. CBA’s Sustainability Hub is helping members understand their commitments now and how they can make a difference going forward.

Although the past few years have been challenging, the industry has been largely resilient and continues to adjust and adapt. Looking forward, the only thing that is certain, is that the future will involve more change and uncertainty.

In this presentation I will discuss how lessons learnt from the past can help to prepare for the future, for both the expected and unexpected challenges ahead.

To operate effectively in the modern day chemical and pharmaceutical supply chain companies need to have a good understanding of the possible uses and misuses to which the chemicals they are manufacturing, supplying, or using can be put.

There are several substances subject to strategic export controls (trade controls) on an international level but also nationally, such as EU and UK, which require differing degrees of paperwork and processes in place to ensure compliance. It is therefore vital that companies keep up to date with the changes to prevent delays, enforcement action or ‘bad press.’

In this presentation I will outline how CBA’s Code of Conduct on trade controls for chemicals is helping member companies not only understand their obligations and the requirements of the legislation, but also gives them practical advice on how they can put this into practise.

The presentation will provide a basic insight into aspects of:

• What to do in practice
• Legal Expectations
• What security measures should be in place

This presentation describes how UV dissolution imaging is being used to provide insights and mitigate against failure in its use in the determination of intrinsic dissolution rates and drug release from whole dosage forms. Several case studies reviewing the effects of various excipients in controlled release systems, solid dispersions, cocrystal systems and hot-melt extrusions formulations will be discussed.  Applications of UV imaging to non-oral formulations have started to emerge and will also be discussed.

This presentation will be of interest to excipient companies, and pharmaceutical companies working in the pre-formulation and formulation sectors.

Twitter: @dr_kasareaddo

Research group twitter: @AsareAddo_RG

Do you have responsibility for the oversight of outsourced manufacture of Investigational Medicinal Products (IMP)?

This talk will introduce basic processes that support the qualification of contract manufacturers in your GMP supply chain. It will demonstrate sponsor oversight for effective management of risks associated with the manufacture of IMPs. Anonymised events at manufacturing sites that benefited from sponsor feedback by documented risk assessment will be given.

Start as you mean to go on. Make sound risk-based decisions when selecting vendors, confirming their GMP manufacturing process, and assessing events that occur during manufacturing by using a simple pragmatic quality system.

Latest equipment developments that can see and report microbial bioburden in air and water as it happens, will be presented, with how it fits with Annex 1 compliance explained

Homegrown 3D printing was thrust into the global mainstream as a temporary healthcare solution to support efforts to fight COVID-19, but with global supply chains still reeling from the pandemic, there continues to be a focus on building resilient, long-term, production capabilities across the pharmaceutical industry. This presentation takes a unique approach to detailing how the role of the three pillars of industrial 3D printing goes far beyond a stopgap and describes how innovative pharma manufacturers can take advantage of this technology to drastically reduce downtime, improve supply chain security and make significant efficiency gains.

Microfluidic chips have revolutionized the manufacturing of lipid nanoparticles and the development of novel drug delivery systems. The use of microfluidic devices offers great advantages in the optimization of lipid nanoparticles with decreased experimental times, complex flows, excellent mixing and high reproducibility. Our studies have demonstrated the continuous manufacturing of lipid nanoparticles varying from conventional to Stealth nanoparticles for passive and active targeting of cancer tumours or exosome-like delivery systems.
Our 3D printed microfluidic chips are designed for easy to scale-up production of nanoparticles with a variety of inner structures for efficient mixing of aqueous and organic flows at various ratios and flow rates. Advanced designs can be used for in situ formation of lipid nanoparticles that can be used directly for patient administration.

Pharmaceutical 3D printing is a rapidly growing field, set to change the world of pharmaceutics forever. With the ability to fabricate small batches of precise structures and personalised dosage rapidly, pharmaceutical 3D printing makes personalised medicine safer and more accessible. It also has the ability to drastically improve patient treatment adherence, with personalised colour, flavour, shape and drug combinations (polypills). This technology is now being analysed for different drugs in clinical studies across the world. This presentation will go though the exciting updates the field has to offer, including clinical studies, regulatory updates and how to get involved.

How do you know if you are inspection ready? Being able to demonstrate GMDP compliance is essential to avoid additional costs, licensing delays and reputational damage.
The presentation will cover what being inspection ready means in practice based on insights from former MHRA Inspectors, highlighting expectations for PQS documentation, completion of operational activities, and examples of how to leverage output from the PQS to confirm GMDP compliance. How to prepare for a regulatory inspection will also be discussed, highlighting practical considerations for hosting the inspection and advice on how to present information to demonstrate GMDP knowledge and compliance.

On 25 November 2020 the European Commission (EC) published a pharmaceutical strategy document, which they said was the first step in a “complete overhaul” of the medicines legislative framework for human medicines to be proposed in about two years’ time. Commission vice-president Margaritis Schinas told a press conference on 25 November 2020 “We will be completely overhauling the entire legislative medicines framework – a set of rules that is 20 years old and badly needs modernisation”.

The presentation will look at the most important changes in the EU HMRs including those that directly impact UK manufacturers and I plan to discuss the impact of the Windsor Framework.

The presentation will explore the DI and CSV challenges faced for new start-up companies progressing towards regulatory licence. Recent years have seen a vast increase in the volume of new organisations starting up especially in the areas of Cell Gene Therapy, mRNA and DNA technology.

While these organisations may be leading edge with regards to the science and technology, of the aspect of DI and CSV compliance is seen as a secondary or even lower priority - until the aspect of submission for licence inspection occurs.

In addition to the pure DI and CSV journey there are a number of additional areas that need attention during this journey, the presentation will draw on the experience gained in the last 2-3 years helping a number of clients on this journey to successful licence.

• How to navigate the intimidating scale of the supply-side
• What you need to ensure your API supply chain is compliant
• API testing: no chemistry, but examples of problems that can arise between labs