I like to think that in a previous life (or maybe in a future life) I was an efficiency expert.
Ed Price
COVID-19 continues to take a toll at home and in business. As companies everywhere work to adjust to a new way of working, those of us in the Contract Development & Manufacturing Organization (CDMO) world may have an advantage. As essential work, many of us have maintained ongoing on-site operations, and as chemical manufacturers, we have always been committed to strict cleaning guidelines.
Vicky Qing Xia, Leo Yang
Both multinational and domestic Contract Development and Manufacturing Organizations (CDMOs) are striving to enter this new segment in China. The recent regulatory reforms, and the potential opportunities are creating an upswell in investment and interest.
Anish Parikh
In this article, we will chart the rise of the PFS, outline some common challenges, and explain how partnership is the only route to success.
Erik Haeffler
Many recognized drug development challenges are impacting oral solid dose (OSD) manufacturing.
Fergus Manford, Matthew Green, David Thomas
The mechanical process of reducing the size of a material using high-energy systems is known as micronization. There are two major benefits from reducing the size of the particle in a pharmaceutical product: firstly, broader ranges of target sites are available; and secondly, smaller particle size results in an increase in the surface area and this facilitates improved clinical efficacy. The resultant particles are physically unstable with regions of induced disorder, otherwise known as amorphous material.
Mark Demesmaeker, Dan Kopec, Artur Miguel Arsénio
The term Bioprocessing 4.0 has been tossed around since 2018 and is derived from Industry 4.0, a national strategic initiative from the German government launched in 2010 with the aim of driving manufacturing forward by increasing digitization and the interconnection of products, supply chains and business models.
Amy Hodler
The life science manufacturing and supply sector has seen unprecedented disruption. Many pharmaceutical manufacturers have had to pivot their product lines within weeks and global supply lines have struggled to fulfill changing demands. Post pandemic, life sciences companies will be taking a long, hard look at how they can build more robust supply chains. Graph database technology that records and handles complex data interdependencies is increasingly critical.
Xavier Duburcq
Life sciences regulators exist to hold companies to account and keep customers safe, by enforcing certain standards and ensuring that manufacturers adhere to them over time (and can demonstrate, on demand, that they have done so). In the pharmaceutical sector, manufacturers have become accustomed to the significant and increasing ‘burden’ of regulatory compliance: of having to update their processes, systems and skills to accommodate the latest reporting requirements.
Mark Walker, WuXi AppTec
Drug development companies come in all sizes and compositions, and it is safe to assume that no matter the makeup – they are all feeling the effects of the global pandemic, both professionally and personally, in their communities.
Frederick Murray
Tablet press design innovation has traditionally centered on largescale production equipment, however, there is increasing focus on the smaller-scale, mid-range models that must have the capability to support product development, scale-up, tech transfer, clinical batch manufacturing, small and medium batch production, and continuous manufacturing applications. This range of capabilities demands unique features and design flexibility.
Vibhor Gupta, Ph.D., Jaleel Shujath, MBA
Gene therapy holds enormous promise, revolutionizing the way we
approach and treat diseases, including many that were previously
considered incurable.
Nicole Gray
The global COVID-19 pandemic has had a significant impact on all our lives, forcing us to adapt and find creative ways to continue our day-to-day lives. Clinical trials are no exception and have had to face many new challenges. Due to local lockdowns, patient and site staff safety, and personal choice, some patients have been unable or unwilling to travel to their clinical site and in some cases, clinical sites have had to close completely.
Narine Baririan, PharmD
Early phase clinical trials are becoming increasingly complex, potentially leading to a higher risk of failure. But careful planning and attention to some key areas in the early phase can mitigate the challenges.
Graeme Dennis
Asked about obstacles that make them second-guess outsourcing work to bioanalytical contract research (CROs), pharmaceutical companies do not mince words: “regulatory compliance and scientific expertise,” and “unresponsiveness and imprecise data”1 are among the more cutting remarks.
Sam Brogan, PhD
The increasing complexity of New Chemical Entities (NCEs) entering the drug pipeline has fuelled demand for hazardous chemistry techniques which can provide a more efficient route to molecules.
Sunny Christian, MS, Neelam Sharma, MS,, Hemant N. Joshi, Ph.D., MBA
This quarterly review on New Drug Applications contains data for applications approved for the first time during April-June of 2020, which includes New Molecular Entities (NMEs) and new biologics. A total of 43 applications were approved by FDA during these three months.