Newsletter | August 14, 2019

08.14.19 -- 4 Important Considerations For Drug Delivery Device Development

Featured Editorial
4 Important Considerations For Drug Delivery Device Development
By Michael Song, Ph.D.

This is Part 1 of a two-part article covering important considerations when developing devices for combination products — and why they need to be addressed early in development. In this installment, we'll discuss primary container, device development, device selection, and design control.

3 Surefire Approaches To SOP Harmonization
By Penelope Przekop

We seem to be buried in standard operating procedures (SOPs). So how the heck are companies supposed to make the SOP mountain smaller through harmonization?

Industry Insights
Key Concepts Driving The Future Of Single-Use In Biopharma
White Paper | By Matthew Olsen, Sartorius Stedim Biotech

Familiarity and experience with single-use products are leading to a grassroots demand for advancement in the science and technology of single-use bioprocessing. This article discusses four key topics related to single-use bioprocessing that are commonly cited by end users as amenable to future development. 

Is Your CMO Ready For Serialization And Aggregation?
White Paper | By Lloyd Mager, AbbVie

While some are waiting for mandates for traceability, serialization, and aggregation, others are recognizing the inevitability of these strategies. Does your CMO have a dedicated traceability operation in place?

Utilizing External Collaboration To Accelerate Vaccine Development
White Paper | By Chris Rode, Janssen Biotherapeutics Development

Securing a partner to serve as an extension of Janssen’s biotherapeutics development API-large molecule team was essential to reduce both risk and the time needed for delivery of clinical supplies.

7 Key Areas Of Risk In Single Use Bioprocessing: Is Your Process Protected?
Article | By Andrew Kelly and Graeme Proctor, Parker Bioscience

Is your bioprocess adequately protected against the risks associated with single-use technology (SUT)? Discover the seven key areas of risk in SUT and learn the strategies to protect against each risk.

Developing Immunotherapies For Cell-Based vs. Noncell-Based Therapies
Article | Thermo Fisher Scientific

Both cell-based therapies and noncell-based therapies are developed as immunotherapies and therefore share some similar challenges in development.

Culture Of Human Mesenchymal Stem Cells In Nunc Cell Factory Systems
Application Note | Thermo Fisher Scientific

Helpful methodology that can be applied to the large-scale expansion of other cell types for use in various applications using Cell Factory systems.

How Molecular Structure Influences Potency Of A Therapeutic Biologic
Webinar | MilliporeSigma (product characterization)

MilliporeSigma scientists, ranging in specialty from analytical to immuno-focused, give the listener an understanding of how an antibody’s molecular structure, of which there are many measurable properties that can be measured, influences its binding and affects potency of a therapeutic biologic.

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