Market Reports

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

Manufacturing Chemist LIVE 2023: Expert Speakers Wanted

Previous years have included presentations from the likes of NASA, AstraZeneca, GSK, CMAC and we are now looking for 2023's experts

Cell and gene therapies: on the brink of commercialisation

With their one-and-done potential and pinpoint targeting capability, cell and gene therapies (CGTs) offer huge promise in the fight against a range of previously untreatable diseases. Yet, investment in this sector is not taken lightly. Typically, developers must invest billions of dollars in therapies that might take 10 years to reach the market as they battle the odds against high failure rates

Inspiration from unexpected places

How pharmaceutical companies can learn from advances in nicotine delivery

Overcoming hurdles in the biopharmaceutical pipeline with advanced analytics

In conversation with Nick Pittman and Magnus Wetterhall, both Global Marketing Managers, Bioprocessing, at Waters Corporation, Dr Kevin Robinson explored some of the big issues associated with manufacturing biologics, how they can be overcome and what Waters is doing to help scientists expedite the process of developing new therapies for patients in need

Treating infection with precise medicine may prevent our next pandemic

Antimicrobial resistance (AMR) is a grave concern that the scientific and medical community have been warning the public about for decades. There have been no new antibiotics for 35 years and no truly effective incentive for drug makers to develop them, making this threat even more urgent. As the COVID-19 pandemic demonstrated, preparedness could save countless lives and the world’s economy

Optimising coating process parameters and formulation concepts for functional taste-masking during continuous manufacturing

This article describes work done to optimise the coating process parameters (spray rate, inlet air temperature, inlet airflow), formulation and functionality of a taste-masking coat for oral solid dosage forms during continuous production

Dissolution testing: an established technique driving advances in drug delivery

This article introduces dissolution testing and highlights its ability to support modern formulation challenges. Pharmacopoeial methods are discussed with reference to specific apparatuses and method parameters. Dissolution testing equipment from Copley Scientific is showcased to illustrate the performance and productivity that are accessible with well-designed, cost-effective solutions

COVID-19: focusing attention on the next transformation in healthcare

The lightning-fast global spread of the Omicron variant of COVID-19 was a painful reminder that the only way to protect against the disease is vaccination on a global level. At the same time, South African researchers’ quick identification and analysis of Omicron demonstrated the strength and interconnectedness of the international science community, with critical data rapidly passed to those who were best able to mount a response

Manufacturing Chemist LIVE 2022 in review (part I)

Taking a front row seat during the two-day pharmaceutical conference in Birmingham, UK, Dr Kevin Robinson reports on what’s new, emerging and exciting in the world of drug delivery and beyond

Native mass spectrometry as a drug discovery engine

Using mass spectrometry to characterise and screen large intact protein targets, captured directly in their native state, is making waves as a differentiated approach to hit finding in drug discovery, explains Dr Jonathan T.S. Hopper, founder and VP of Platforms at OMass Therapeutics

Transforming tomorrow

Shaping the future with better processes, GEA has responded to the impact that digitalisation is having on the pharmaceutical manufacturing industry and pioneered a suite of virtual technologies that improve the customer experience

Chemistry meets biology: an integrated approach to developing and manufacturing medicines of the future

Until recently, chemists and biologists rarely needed to collaborate to develop a new large molecule drug, reports Chris Conway, President, Research and Development, Curia

Closing the gap between biotherapies and their quality control

NGS-based biosafety tests are giving the biomanufacturing industry a facelift

Trending Articles

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    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
  2. 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
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    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
  4. 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
  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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Enhancing probiotic stability through smarter formulation and packaging strategies

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