Market Reports

Poolbeg granted FDA Orphan Drug Designation for POLB 001

The US FDA grants orphan status to support the development of medicines for rare disorders affecting fewer than 200,000 people in the US

From data silos to streamlined connectivity: how biopharma can prepare for ESMP

Sponsors that centralise their product information will not only help to pre-empt drug shortages but also improve their capacity for collaboration with connected systems and data

Freeze drying ADCs: points to consider for industrial applications

As antibody-drug conjugates gain momentum in the pharmaceutical industry, manufacturers are increasingly looking to implement safe and effective process trains to produce them. Lyophilisation experts at GEA Pharma & Healthcare assess some of the most critical challenges and how to overcome them

The ABCs of ADCs: manufacturing ultra-high potent active ingredients

Senior Technical Manager at Sterling Pharma Solutions, Matt Miklas, presents a pragmatic approach to the safe and cost-effective production of highly potent pharmaceutical molecules, including antibody-drug conjugate (ADC) payloads

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

Trending Articles

  1. The economic advantages of continuous flow chemistry Batch production has been the traditional workhorse of the pharmaceutical manufacturing sector. However, economic advantages are taking continuous flow out of the realm of a niche technology for high energy, hazardous reactions to become an essential part of the small molecule manufacturing toolkit
  2. 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
  3. Peak identification by LC/MS: Automation versus analyst High pressure liquid chromatography/mass spectrometry (LC/MS) is an important technique that facilitates the correct and accurate identification of impurities in pharmaceutical products and intermediates
  4. Poolbeg granted FDA Orphan Drug Designation for POLB 001 The US FDA grants orphan status to support the development of medicines for rare disorders affecting fewer than 200,000 people in the US
  5. Rare diseases: understanding the patient journey In the shadow of Rare Disease Day on 28 February 2019, Dr Kevin Robinson met with Zizi Imatorbhebhe, Senior Director of Strategic Development and Head of PAREXEL’s Rare Disease Center of Excellence (RDCE), to discuss the future of rare disease research

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