Market Reports

Why potency assays are a crucial consideration for CGT manufacturers

Potency assays can enhance the efficiency of cell and gene therapy development and commercialisation while also bringing down costs

How iPSCs can bridge the translational gap in neuroscience

Affecting more than one in three people, neurological disorders have a vast impact on global health while exacting a tremendous cost, reports Dr Max Mirza, Vice President of Neuroscience Drug Discovery at Sygnature Discovery

Clinical trials: current insights and future perspectives

To keep up with the ever-evolving landscape of clinical trials, companies must conform to regulations and consider how to make the study process patient-centric

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

ACHEMA 2024 champions a competitive pharmaceutical industry

More than 2800 exhibitors from 56 nations — as well as 106,001 attendees from 141 countries — gathered in Frankfurt for ACHEMA 2024 to showcase the latest equipment and processes for the pharmaceutical industry

How predictive and preventive maintenance can optimise your pharmaceutical manufacturing line

With a tailored approach to maintenance, manufacturers can extend their system’s lifetime and anticipate time-consuming breakdowns before they happen

Factors driving the expansion of the multiple myeloma drug market

The multiple myeloma market has seen a range of immune-targeting therapeutics gain accelerated approval from the US FDA … and sales are predicted to skyrocket in the coming years

Biosecurity threats and business as usual

A new version of a United States congressional bill (the Biosecure Act) that restricts US companies from doing business with certain Chinese biotechnology organisations, including WuXi AppTec and WuXi Biologics, gives American companies until 2032 to terminate their associations with these firms and find new partners

Annex 1-compliant freeze drying: a technology supplier’s perspective

Jessica Wagner, Validation Engineer at GEA, tells Dr Kevin Robinson how the company has embraced the updated version of Annex 1 and implemented the new changes. Key objectives were to remain compliant and demonstrate to their customers — both current and future — how the amends would be incorporated into ongoing or upcoming projects

Optimising labelling with robotics for improved accuracy and efficiency

Robotics can significantly enhance the labelling process during pharmaceutical packaging by increasing accuracy whilst reducing costs and labour

How efficient compressed air delivery can save you money

Investing in optimal filtration systems for compressed air delivery is crucial in saving money and reducing energy usage

How to proactively address EU HTAR implementation challenges before 2025

Data landscape challenges within the European Union (EU) have historically been driven by the different laws, processes and regulatory standards of its 27 member states (MS). As a result, drug therapeutics and health technology developers have faced the challenge of duplication of assessment efforts

Adding more to the cell and gene therapy playbook

With notable advances in various forms of administration, including making the use of viral vectors safer, non-viral delivery with lipid nanoparticles and the growing application of electroporation, Dr Kevin Robinson (KSR) recently caught up with Jason Potter (JP), Director of Cell Biology R&D at Thermo Fisher Scientific, to learn more about how the company is helping the pharmaceutical industry to develop cell and gene therapies

What to consider for successful GMP Annex 1 implementation

In advance of her presentation at Manufacturing Chemist Live, Dr Nicole Hunter (NH), Head of Global Regulatory and Validation Services at Watson-Marlow Fluid Technology Solutions, and colleague Claire Hutchison (CH), Life Science Specialist, provide their insights on the updates to the European Commission’s Good Manufacturing Practices (GMP) Annex 1 and the role of single-use systems

Highly potent formulation development in oncology

Formulation development is a dynamic and experimental process. However, certain challenges are presented to CDMOs that add a layer of unnecessary pressure to the development process — some of which are avoidable. Louise Carpenter from PCI Pharma Services discusses

Going beyond the guidance: getting business benefit from change management

Change management offers a broad, system-wide perspective that includes the oversight and management of all changes and the change process. Michelle Anastasi of PharmaLex explores what good change management looks like and who should be involved

QMM: a natural development of pharmaceutical regulation?

During the pandemic, we saw a rapid evolution of inspection approaches that showed how the sector — and indeed the regulators — can adapt to new operational models

SCHOTT Pharma reveals strong financial performance in fiscal year 2022

In a record year of growth, sales increased by 27% to EUR 821 million and EBITDA by 33% to EUR 219 million on a preliminary basis

Made in Switzerland: blockchain enabled healthcare

Interoperable blockchain-enabled solutions could eliminate waste, enhance security and privacy, build trust and, ultimately, benefit patients and the entire pharmaceutical value chain, say the founders of PharmaLedger. Dr Kevin Robinson dialled in to find out more

Brenntag signs multi-year partnership with Workday Human Capital

The chosen Workday HCM solution will be tailored and implemented in the course of 2023 to meet the needs of Brenntag

From food to pharma: antioxidant scavengers as a viable strategy to mitigate nitrosamines in drugs

Stakeholders throughout the pharmaceutical value chain have had to deal with the recall of nitrosamine-containing medications, loss of revenue and, in some cases, reputational damage. Meanwhile, regulatory authorities have put stringent measures in motion to protect patients from potentially harmful medications, putting reformulation at the forefront of drug manufacturers’ minds, reports Anne-Cecile Bayne, Global Science and Innovation Lead, Pharma and Medical Nutrition at DSM

FUJIFILM launches viral vector feed designed to increase yields

FUJIFILM Irvine Scientific has launched its BalanCD HEK293 Viral Feed designed to boost adeno-associated viral vector (AAV) production for gene therapy applications and viral vector-based vaccines

Catalent signs development deal with Ethicann for new fast-dissolve cannabinoid treatment

Catalent and Canadian/US cannabinoid drug therapy company Ethicann Pharmaceuticals have executed a development and license agreement that will use Catalent’s proprietary Zydis orally disintegrating tablet (ODT) technology

Host cell protein analysis: strategies to improve sensitivity and reproducibility

Given that the US FDA approved 25 new cellular and gene therapy products in 2022, gene-based vaccines and therapeutics have now entered the mainstream pharmaceutical industry. However, the rising interest in gene-based strategies puts pressure on manufacturers to demonstrate optimum efficacy and safety

Trending Articles

  1. How iPSCs can bridge the translational gap in neuroscience Affecting more than one in three people, neurological disorders have a vast impact on global health while exacting a tremendous cost, reports Dr Max Mirza, Vice President of Neuroscience Drug Discovery at Sygnature Discovery
  2. The modularisation of chemical API synthesis The modularisation of chemical synthesis pathways in pharmaceutical production can improve overall plant efficiency and reduce planning time. Glatt Ingenieurtechnik has optimised the active pharmaceutical ingredient (API) synthesis process and developed bespoke plant designs for several international customers
  3. 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
  4. Clinical trials: current insights and future perspectives To keep up with the ever-evolving landscape of clinical trials, companies must conform to regulations and consider how to make the study process patient-centric
  5. Why potency assays are a crucial consideration for CGT manufacturers Potency assays can enhance the efficiency of cell and gene therapy development and commercialisation while also bringing down costs

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