Market Reports

Developing strategies for robust chemistry, manufacturing and controls execution for advanced biologics

Chemistry, manufacturing and controls (CMC) is a fundamental discipline for complex drug development projects. It must be rigorously implemented to navigate stringent regulatory requirements before drug approval and commercialisation

How CRDMOs are shaping the next generation of antibody-drug conjugates

To explore how CRDMOs are leading innovation in ADC development, Dr Kevin Robinson spoke with Srivats Rajagopal, Senior Director, Cell and Protein Sciences, Biology Solutions at Aragen Life Sciences, about key technological advancements and evolving partnership models that are redefining what it means to outsource in this space

NICE recommends enfortumab vedotin with KEYTRUDA for adults in England/Wales with untreated metastatic urothelial cancer

The results from the Phase III study EV-302/KN-A39 showed nearly a doubling of survival rates in patients compared with those who received platinum-based chemotherapy, which is the current standard of care in the UK

Start with the end in mind: the role of materials control in early CMC strategy for cell therapies

Cell and gene therapy products are complex in their design, nature and mode of action. Because of this, the road to market can be a challenging one; littered with variables and failures, what might have been a valuable treatment often fails to reach much-in-need patients

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

Excipients step into the spotlight with sustainable and nano solutions

How multifunctional and natural materials are reshaping formulation science

How onco-HPAPI manufacturing is adapting to a new era

The oncology landscape is undergoing a quiet but powerful shift. Pharmaceutical companies, once focused primarily on novel compounds, are now increasingly exploring repurposing opportunities with existing high-potency oncology APIs (onco-HPAPIs)

Outsourcing in pharma: a comprehensive guide to strategic advantages and considerations

Outsourcing in pharma drives agility, compliance, and efficiency—NSF delivers expert audits, training, remediation, and embedded support

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

Trending Articles

  1. 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
  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. Reading and understanding vendor-supplied tablet drawings Understanding the tablet drawings supplied by tooling vendors is a meaningful way to learn more about your product, reports John Norman, Technical Service Representative, Natoli Engineering Company
  5. Model-based optimisation of mixed solvent systems for spray drying Spray drying is a common and effective approach to enhance the bioavailability of low-solubility small molecules. As the process requires intimate knowledge of aspects such as droplet trajectories, in this article Jonathan L. Cape, Kimberly B. Shepard and Michael M. Morgen, from Lonza Pharma & Biotech, examine different approaches to spray drying and ways to optimise drug production and quality

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