The ISPE Drug Shortages Initiative Team conducted a webinar on 9 February 2023 to discuss regulatory and industry insights on drug shortage prevention with a focus on the Asia-Pacific region. The webinar was moderated by Vivien Santillan, Regional Director, Asia, Novatek International. Regulatory speakers were Lisa Hedman, Group Lead for the Division of Supply and Access to Medicines of the...

Following the recent surge in popularity of mRNA technology due to Covid-19 vaccines, we are beginning to realise its impact and potential in this field and for oligonucleotides. However, we face a steep learning curve in understanding the diversity and specifics of the manufacturing chain that make this new generation of RNA drug products completely different from traditional biologics (e.g....

Digital initiatives are becoming increasingly abundant and important, but many large organizations, particularly in the life science sector, struggle to implement and roll out these initiatives successfully. A common reason for this is that digital transformation efforts often fail to successfully move from the boardroom to the plant room, resulting in a disjointed user experience with limited...

The ISPE GAMP^® Blockchain Special Interest Group is excited to be in its 4th year! For those of you following this space I’m sure you can appreciate the roller coaster of events across crypto, blockchain, and pharma over that time. Yet despite many of the external challenges the core technology behind blockchains has remained secure, available, and immutable – just as they were...

Are you interested in developing a new bioproduct and attracted by the incredible potentials of new modalities like ATMPs, Cell and Gene Therapies, AAVs, oligonucleotides, multi-specificity antibodies, mRNA vaccines, and more? Despite the appeal of these new modalities, there is a significant risk of failure due to the many unknowns associated with these new technologies.

The needs of patients provide the impetus to challenge the notion of “this is the way we’ve always done it.”

Speed to market is a major priority for life sciences companies and this is going to be a featured topic during the 2023 ISPE Biotechnology Conference. More than ever before, biotechnology companies are pushing for exponential growth by expediting the scalability of manufacturing processes and the use of different modalities. This can significantly accelerate patient access to life-saving...

Industries around the world are working to reach carbon neutrality. By reducing greenhouse gas emissions or removing carbon dioxide from the atmosphere, companies can effectively make up for the emissions they produce elsewhere. Think of it like planting a tree in one place for every tree you cut down elsewhere. In theory, if you plant as many trees as you cut down, you will reach “net-zero...

When a Project Manager (PM) joins a new qualification project for a new production plant, the first thing to do is to gather information so that you will know the scope of the project very well: all the systems, equipment and services that are part of it and the scopes of the different qualification phases. In addition, the key members of each area and their level of support must be...

The use of robotics to manufacture Advanced Therapy and Medicinal Products (ATMP) solves many challenges, including significantly limiting exposure to human generated contamination. There are steps to mitigate contamination points but with the strong endorsements recently made within the current revision to Annex 1 encouraging the use of robotics (Section 8.9),1

As the biopharmaceutical industry grapples with faster commercialization of new drugs, along with an increased focused on sustainability, process simulation has never been more relevant. Whether for risk assessment or optimization, process simulation aims to represent a chemical or biochemical process by modeling the governing mechanisms that affect quality, yield, throughput, environmental...

The impact of paperless validation on the biotechnology industry is massive, and the overall effect is growing as adoption increases. Paperless validation is applicable to every type of validation in biotech: cleaning, process, equipment, facilities, utilities, and many others. Twenty percent of a project’s budget is devoted to validation activities, so streamlining profoundly impacts the...

The advantages that come with a fully digitalized plant for manufacturing biopharmaceuticals are well documented and showcased throughout the biopharmaceutical industry and will be a featured topic during the 2023...

We are The Culture Club, a self-formed cross-CoP group of individuals who came together to discuss challenges encountered as we transition quality and validation into the digital world and identify ways to influence cultural changes needed within our industry to better enable innovation. As we are not all from the same CoP, we first needed to establish a way to connect and collaborate with all...

On 17 December 2022, more than 100 people from all over the world gathered online for the 2022 China Pharmaceutical Supply Chain Summit hosted by Shanghai ISPE Pharmaceutical Information Company (SPIC). With multiple geopolitical and pandemic related challenges in recent years, having a robust supply chain has increasingly become a strategic advantage for the pharmaceutical industry. The...

In the iSpeak Blog posting on 14 March 2023, the first part of this blog series introduced the results of a survey that was conducted of users of single-use assemblies. The focus...

Members of the paperless validation subcommittee created this blog post to discuss and recommend “true copy verification practices” for the use of Paperless validation systems to satisfy the current guidance for data integrity, and to discuss how to fully eliminate paper from various validation processes without impacting compliance to these current regulations.

The Biopharmaceutical industry continues to grow and deliver life-changing medicines to patients as evidenced by the number of drug approvals by the FDA year after year. In 2022 alone CDER approved 37 novel drugs, either as new molecular entities (NMEs) under New Drug Applications (NDAs) or as new therapeutic biological products under Biologics License Applications (BLAs). This has all been...