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Market Reports
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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Trending Articles
A rules-based approach to labelling and artwork management: Part I
Many organisations today are experiencing unprecedented demands from regulatory authorities and consumers alike for product labelling to be made clearer and more informative, says Graham Francis, Channel Marketing Manager, Kallik
A microfluidic approach to production of alginate beads for cell encapsulation
Gurinder Vinner, Material Scientist at Dolomite Microfluidics, discusses the benefits of continuous microfluidic production for the encapsulation of mammalian cells with no loss of viability
Recombinant versus synthetic peptide synthesis: the perks and drawbacks
Since the introduction of novel peptide drugs into the market, the demand for polypeptide manufacturing has significantly increased, reports Dr Philipp Markolin
UK pharma shifts as Merck and AstraZeneca scale back: can CDMOs fill the gap?
Recent major site withdrawals and investment pauses have raised concerns about the UK’s industrial strength. But CDMOs say agility, innovation and technical expertise could redefine how and where drugs are made
CMC strategies for the acceleration of commercial-ready ADC manufacturing
The potential for antibody-drug conjugate (ADC) programmes to accelerate from early to late stage clinical development highlights the need to establish commercial launch-ready manufacturing early and efficiently, reports Courtney Morgret, Senior Scientist, Manufacturing Sciences, AbbVie
Upcoming event
CPhI Milan
6–8 October 2026 | Exhibition | Fiera Milano, Italy
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