PTF issue 99: Inside manufacturing inspections

25 September 2020 (Last Updated September 25th, 2020 10:35)

PTF issue 99: Inside manufacturing inspections

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The fight against Covid-19 has thrust antibody drugs into the spotlight, with a number of high-profile companies putting their money behind antibody-based therapeutics. But, while this level of interest may be new, antibodies have been a key area of pharma R&D for a very long time. To find out more, we take a look back at key developments in antibody drugs innovation and, as regulatory inspections begin to resume, we explore the criteria that manufacturers must meet to prove production processes are up to scratch.

Also in this issue, we take a look at the therapeutic potential of the ‘love hormone’ oxytocin, examine the benefits of using AI-enabled risk detection software to increase product quality and process efficiency in pharmaceutical manufacturing, and investigate the potential long-term health impacts of Covid-19.

Plus, we round up the latest developments in retinitis pigmentosa gene therapies, find out what is behind the growing number of investments in the fertility treatment market, examine new drug developments for coeliac disease, and learn why pharmacovigilance departments are failing to automate data capture.

 

In this issue

From antitoxins to Covid-19 drugs: Charting the history of antibody drugs
Covid-19 has plunged antibody drug development into the spotlight, but antibodies are not a new area of pharma R&D. More than a century of successive discoveries and breakthroughs are the main reason why big pharma has been able to react so quickly to the pandemic. Allie Nawrat looks back at the history of antibodies as a therapeutic modality.
Read the article here.

Quality control: Pharma manufacturing inspections explained
Inspection of drug manufacturing sites is a key step in securing marketing approval and safeguarding patient health. What are the fundamentals of conducting effective inspections of pharma production facilities? Chris Lo finds out.
Read the article here.

Oxytocin: the therapeutic potential of the ‘love hormone’
The bonding effects of oxytocin are well known; now a team of researchers from Tokyo University of Science have identified the hormone as a possible therapeutic modality for Alzheimer’s disease. Abi Millar takes a look at their research, along with other studies that examine the potential of oxytocin.
Read the article here.

AI-enabled risk detection in pharma manufacturing
Quartic.ai and Sparta Systems are collaborating on an AI-enabled risk detection software for pharmaceutical manufacturing operations, intended to increase both product quality and process efficiency. Their goal is to come up with solutions that can help detect risks early in the pharma manufacturing process, reducing product quality impact and enabling near-real-time product release. Abi Millar reports.
Read the article here.

 

Addressing the long-term effects of Covid-19
Evidence is emerging that the health effects of Covid-19 might go far beyond the initial symptoms of infection. Research suggests survivors may face severe long-term damage to the lungs and other organs, as well as central nervous system damage and the increased incidence of blood clotting. Abi Millar finds out more.
Read the article here.

Eyes on the prize: the latest in retinitis pigmentosa gene therapies
In patients with retinitis pigmentosa, the photoreceptors in the eye that are responsible for converting light into signals sent to the brain don’t function as they should, leading to degeneration of the retina and eventual blindness in adulthood. Interim data from an ongoing Phase I/II study has found low doses of a new gene therapy can improve vision for certain RP patients. Chloe Kent finds out more.
Read the article here.

Breaking the taboo: disrupting the fertility sector
Analysis from Octopus Ventures has found that investment into fertility treatments and companies increased almost fourfold between 2014 and 2019 to a total of $2.2bn. Octopus Ventures predicts investment will continue to grow in the coming years as result of both changing attitudes and various innovations in the fertility space. Allie Nawrat looks at the future of infertility drugs to support IVF treatments.
Read the article here.

Neutralising the gluten threat: Are we on the cusp of a coeliac disease breakthrough? 
Different from a gluten intolerance, coeliac disease causes long-term damage to patients’ small intestine and puts them at risk of other medical conditions. Treatment options are urgently needed as management using a gluten-free diet is insufficient for the vast majority of patients. Allie Nawrat explores the promise of larazotide, the drug in development currently leading the pack, and what the future could hold for these at-need patients.
Read the article here.

Pharmacovigilance case intake: Why the hesitation to automate?
Why is it, with all of the advanced technology available to them, many pharma company PV departments are failing to automate data capture – especially in the context of adverse event reporting? An exclusive new Censuswide survey has sought to provide some answers. Peter Kohut, Arriello’s director of drug safety, discusses the findings.
Read the article here.

Next issue preview

As Covid-19 vaccine candidates make their way through the clinical trial process, we investigate what can be done to counter the growing number of antivaxxers that oppose a pharmaceutical intervention. Plus, we take a look at the rising number of gout diagnosis and what pharma is doing to tackle this surge.

Also, we examine innovative ways to treat chronic pain without painkillers, find out what is being done to fix a lack of equal representation of Black, Latinx and Native American people in Covid-19 drug trials, and learn about Genoskin’s unusual alternative to animal testing that uses human skin models collected after plastic surgery procedures.

Plus, we take a look at a new breast cancer ‘ecosystem’ that contains promising new therapeutic targets for the pharma industry, speak to Atomwise about the company’s drug discovery platform AtomNet, and explore the potential of quantum computing in life sciences.