Newsletter | November 18, 2020

11.18.20 -- You Don't Know Phlow: The Backstory Of A Misread Biopharma Start-Up

From The Editor
Featured Editorial
Industry Insights
Does Your CDMO Have Sustainable API And RSM Strategies?

To prevent costly delays in your timeline, you must be sure the CDMO you select has appropriate oversight of their registered starting materials (RSM) and API manufacturing supply chain.

Bridging The Skills Gap In Biopharma

Employees must have the skills to effectively execute on process development and manufacturing operations. How do you ensure they are updated on complex bioprocessing techniques and technologies?

What You Should Know About Cell Line Development To Ensure A Successful Launch

Effective, strategic cell line development positions your product for regulatory and commercial success. When it comes time to develop your cell lines, here are the crucial factors to consider.

Operational Advantages Of Using Hot Melt Extrusion To Create Amorphous Solid Dispersions

The limited solubility of many modern drugs frequently translates to low bioavailability, making improved solubility a primary goal of oral dosage formulation development. Low aqueous solubility can be combated through preparation of an amorphous solid dispersion (ASD). This article explores spray drying and hot melt extrusion (HME), which are among the most widely applied technologies for producing ASDs.

Understanding The CMC Regulatory Landscape For Cell And Gene Therapy Products

The curing potential of cell and gene therapies is driving the industry’s passion and motivation to gain a better understanding of the evolving regulatory guidelines for these products, in order to bring them to market faster.

Particle Engineering For Inhalation Drug Delivery

Inhalation-based drug products play a critical role in addressing the rising incidence of respiratory diseases around the globe. Particle engineered-based formulations are key in designing and developing effective dry powder inhaler (DPI)-based drugs. This article discusses key parameters for choosing the right particle engineering approach to meet DPI target product profiles.

Strategic CDMO: Bringing End-To-End Solutions For Faster Drug Development

Patheon's Bill Weiser discusses how a new generation of CDMOs have positioned themselves to provide strategic solutions that not only complement product development but drive therapies to patients faster.

Technical Considerations For Developing Oral Solids (Part 2)

What technical considerations should be at the forefront for your oral solids project? This two-part series features four oral solids experts from Pfizer CentreOne’s global network and partner organizations discussing the technical considerations to be aware of. In the second installment of the series, our experts consider the effects of equipment design and different tablet strategies.

It Hasn’t Been Easy For Pharma To Be Green

Most of the drugs coming to market today are acquired by large or midsize pharma companies from small biotech companies. Partnering with a CDMO proficient in green chemistry and manufacturing can help a biotech create the most attractive drug package — one that includes a proven commercialization process minimizing toxic waste that poses safety concerns or requires costly remediation.

Are You Protecting Your Employees During HPAPI Manufacturing?

As biomanufacturers venture into the rapidly growing market of HPAPIs, it is important to consider whether they have the resources and capabilities to protect their product and their employees.

Why Are Lipid Formulations Commonly Used To Enhance Bioavailability?

A discussion on potential mechanisms of increased absorption with lipid formulations, screening tools used during the development of these formulations, scale-up, and industrialization considerations. 

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How To Hire A New Generation Of Biopharma Workers For An Outsourcing Model

Are you productively filling the open positions in your organization? New recruiting strategies are needed to attract and keep the best of a new generation of biopharma workers. In today’s highly outsourced model, technical experience must be matched carefully with “people skills” and the right attitudes. Not to mention, currently you have to do this in the middle of the COVID-19 pandemic. Some good news? We assembled a panel of experienced HR and external supply chain professionals, and the founder of three Centers for Biopharma Education and Training (CBET), to offer you their best practices and answer your questions.