Market Reports

Driving biotherapeutic development with advanced molecule characterisation

Driving biotherapeutic development with advanced molecule characterisation

Evaluating and characterising complicated protein structures and the therapeutic activity of advanced biotherapeutic molecules requires sensitive analytical technologies and informatics systems. As such, executing accurate, analytical assessments of complex biological molecules in a commercial laboratory setting can be challenging, explains Eliza Lee, Lead Scientist Analytics, Samsung Biologics
Deciding on a chemistry, manufacturing and control strategy for biologic development

Deciding on a chemistry, manufacturing and control strategy for biologic development

Khanh Ngo Courtney from Avomeen discusses what biopharmaceutical companies should keep in mind as they embark on their CMC journey
The new regulatory world for medical devices

The new regulatory world for medical devices

Establishing an effective compliance strategy now ahead of the 2022 IVDR legislation is critical — because there’s more to come
Manufacturing vaccines, digital twins and lessons learned: part I

Manufacturing vaccines, digital twins and lessons learned: part I

Using a digital replica of the manufacturing process, the pharmaceutical industry is exploring the ability of virtual technology to improve the efficiency and agility of the production chain and expedite time-to-market
Using ddPCR to accurately quantify AAV viral titre and integrity

Using ddPCR to accurately quantify AAV viral titre and integrity

Gene therapy is primed to become the next major development in medicine and bring relief to patients living with diseases ranging from haemophilia to Alzheimer’s disease, write Mark White, Associate Director of Biopharma Product Marketing, and Marwan Alsarraj, Biopharma Segment Manager, Bio-Rad
Opportunities to scale AAV viral vector production for gene therapies

Opportunities to scale AAV viral vector production for gene therapies

Gene therapies hold tremendous potential as a treatment modality for inherited human diseases. This emerging therapeutic approach can correct or replace pathologic mutations, inactivate mutated genes that are functioning improperly and also introduce new genes to help our bodies fight diseases. Thermo Fisher Scientific's Mike Brewer and Alejandro Becerra report
Big names confirmed to speak at Manufacturing Chemist Live

Big names confirmed to speak at Manufacturing Chemist Live

NASA and AstraZeneca have joined the extensive list of speakers for the combined virtual and in-person event
Refining test methods for a new generation of nasal drug products

Refining test methods for a new generation of nasal drug products

The nasal drug product market is currently the focus of considerable research activity. Nasal sprays for local action, such as the treatment of illnesses including allergic rhinitis and hay fever, dominate in terms of market volume and are an important target for generic manufacturers, report Anna Sipitanou, Business Development Manager, and Mark Copley, CEO, Copley Scientific
Taking a holistic approach to quality management

Taking a holistic approach to quality management

Ensuring quality is one of the most important tasks for bio/pharmaceutical innovators and their external partners. This is vital to keep patients safe and healthy, as well as avoid unnecessary regulatory delays during the development process
Real world evidence: helping to end COVID-19 disruption

Real world evidence: helping to end COVID-19 disruption

Truly bringing the COVID-19 pandemic under control will take concerted efforts beyond the rollout of a global mass vaccination programme. Understanding the real-world performance of vaccines and treatments has a key part to play to identify how and when improvements can be made to enhance their effectiveness in the future
Manufacturing Chemist Live: A hybrid event

Manufacturing Chemist Live: A hybrid event

Taking place on 14-15 September, the event will put delegates ahead of the curve in the global pharmaceutical supply chain
Pure, smooth and strong

Pure, smooth and strong

The EVERIC range of pharmaceutical vials from SCHOTT meets the challenges of today’s fill and finish lines
Pharmaceutical reshoring: a healthy requirement, a strategic necessity

Pharmaceutical reshoring: a healthy requirement, a strategic necessity

More than a year into the COVID-19 crisis, the novel coronavirus continues to disrupt our societies, including how the pharmaceutical industry operates; Andrew Badrot, CEO of C<sup>2</sup> PHARMA, discusses the ongoing ramifications of the pandemic
Taking a lifecycle approach to fill-finish success

Taking a lifecycle approach to fill-finish success

Dr Kevin Robinson recently spoke to swissfillon founder and CEO, Daniel Kehl, and Business Development Director, Carole Delauney, to discuss the company’s baptism by fire during the COVID-19 pandemic and how they can help companies succeed in the pharmaceutical industry’s “new normal”
Lessons learned from the COVID-19 pandemic

Lessons learned from the COVID-19 pandemic

As vaccines roll out and COVID-19 cases begin to decline, Amélie Boulais, Head of Market Entry Strategy for Virus Based Therapeutics at Sartorius, reflects on key takeaways that will impact the biopharmaceutical industry’s approach to pandemic preparedness in 2021 and beyond
Harnessing the power of HPAPIs: key considerations

Harnessing the power of HPAPIs: key considerations

Adam Kujath, Senior Director at Sterling Pharma Solutions, discusses the key issues that companies need to consider when embarking on an HPAPI project. He also outlines what can go wrong if the right steps are not taken to ensure effective containment and gives insight into how access to the right expertise can help to accelerate timelines

Trending Articles

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    Terminal sterilisation versus aseptic filling: ensuring drug product safety The sterility of drug products is critical to patient safety. Choosing between terminal sterilisation or aseptic processing to achieve this should reflect the final product’s physical attributes, the required sterility assurance and contamination-control regulations such as EU GMP Annex 1
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    US mRNA policy shift: are vaccine headwinds accelerating oncology focus? With Washington’s stance on mRNA vaccines cooling, Manufacturing Chemist examines whether policy and funding signals could influence the pharmaceutical industry’s most commercially promising frontier: oncology therapeutics
  3. Panthera joins the Association of Multisite Research Corporations (AMRC) Membership strengthens Panthera’s ability to collaborate across the industry, contribute to collective advocacy and help shape the future of clinical research
  4. Empowering patients with self-administration drug delivery devices Incorporating self-administered drug-device combination products into clinical trials benefits patients and manufacturers alike, reports Bill Welch, Executive Director of Market Development at PCI Pharma Services
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    From stockpiles to smart supply chains: how industry wants to fix Europe’s drug shortages An EU-level stockpile may work, but only if it’s flexible, closely monitored and built with logistics in mind. Industry players say drug security will depend less on volume and more on data, digital oversight and early collaboration throughout the supply chain

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