PharmaceuticalOutsourcingQ42020 - 8

Pharmaceutical Outsourcing is one of several outstanding publications available from CompareNetworks, Inc.
Here is a look at the insightful content our readers may enjoy from four of our sister resources: American Pharmaceutical Review,
Biocompare, Labcompare, and OphthalmologyWeb.

Integration of PAT and Data Systems for Manufacturing Process Control
and Quality Improvement
Pharmaceutical manufacturing has been dominated by batch processing for over a century. It has been recognized that significant opportunities
exist for improving pharmaceutical development, manufacturing, and quality assurance through innovation in product and process
development, process analysis, and process control. At the time FDA's PAT Guidance was published in 2004, key high-level methodologies
such as process understanding, process adjustment to accommodate variability, feedback and/or feedforward control had been advocated for
better variability management and process robustness enhancement. Several principles and tools such as PAT tools, risk-based approaches,
integrated system approach, and real time release were advocated. Subsequently, ICHQ8(R2) formulated the design space concept which can
be established by application of, for example, formal experimental designs, process analytical technology (PAT), and/or prior knowledge.

Prioritizing Sample Prep Helps Ensure Successful RNA-Seq
As a result of the large cost reduction for sequencing, RNA-seq is now a more affordable and popular technique in multiple areas, including
clinical applications where the detection of aberrant transcription can be analyzed in human disease. And while each step of the experimental
setup is of critical importance to get the most reliable results possible, and there are a number of ways to increase accuracy and success
of RNA-seq experiments, sample prep stands at a pivotal point in experimental success. RNA-seq is used to understand the landscape of
biologically expressed genes in different conditions and also to uncover non-coding RNAs such as microRNAs and long non-coding RNA.
Studies have shown that differences in sample prep and enrichment can cause large variations in experimental outcomes.

Cell Culture Clarification and Sterile Filtration:
Combining Two Steps Into One
Centrifugation and filtration have been widely accepted as techniques required for clarifying complex cell cultures to recover extracellular
proteins such as monoclonal antibodies (mABs). However, these steps can be time-consuming and costly for labs growing their cultures
in 24 well plates. Cell growth in a 24-well plate presents challenges for fast and efficient clarification and sterilization of the proteins of
interest. To help streamline protein purification workflows, new technology has been developed that employs a 24-well, dual-layer filter
plate combining the cell clarification and sterile filtration functions. The filter plate performs cell clarification and sterile filtration of CHO,
HEK, or other cultured cells in one step, in a single device, in minutes. It is ideal for laboratories that desire faster and more efficient protein
purification workflows.

Overcoming the Daily Struggle of Adherence to
Glaucoma Therapy
Unlike other conditions such as allergy or dry eye where drops provide near immediate relief or improvement, many glaucoma patients do not
see a noticeable impact from their eye drops and do not feel like they are halting progression. For many, drops can be burdensome, especially
if multiple medications are needed and/or require administration multiple times a day. In fact, the average American over the age of 65 takes
four prescription medications, and nearly 40% take five or more Given the population affected by glaucoma skews older, patients may also have
difficulty administering drops due to factors such as an impaired ability to read directions, arthritis or dementia. Lastly, patients may experience
stinging, burning, blurred vision, uveitis and other adverse events that lead them to deviate from their prescribed regimen.

Pharmaceutical Outsourcing |


| October/November/December 2020


Table of Contents for the Digital Edition of PharmaceuticalOutsourcingQ42020

Editor's Message
Editorial Advisory Board
CN Perspectives
Social Media Connections
Insider Insight - Price
Insider Insight - Ventura
Contract Manufacturing
Supply Chain
Contract Manufacturing
Interview with Yourway
Supply Chain
Clinical Trials
Supply Chain
Analytical Testing
Supply Chain
Clinical Trials
Analytical Testing
Horizon Lines
Industry News
Advertiser's Index
PharmaceuticalOutsourcingQ42020 - Cover1
PharmaceuticalOutsourcingQ42020 - Cover2
PharmaceuticalOutsourcingQ42020 - 1
PharmaceuticalOutsourcingQ42020 - Editor's Message
PharmaceuticalOutsourcingQ42020 - 3
PharmaceuticalOutsourcingQ42020 - 4
PharmaceuticalOutsourcingQ42020 - 5
PharmaceuticalOutsourcingQ42020 - Editorial Advisory Board
PharmaceuticalOutsourcingQ42020 - 7
PharmaceuticalOutsourcingQ42020 - CN Perspectives
PharmaceuticalOutsourcingQ42020 - Social Media Connections
PharmaceuticalOutsourcingQ42020 - Insider Insight - Price
PharmaceuticalOutsourcingQ42020 - 11
PharmaceuticalOutsourcingQ42020 - Insider Insight - Ventura
PharmaceuticalOutsourcingQ42020 - 13
PharmaceuticalOutsourcingQ42020 - Contract Manufacturing
PharmaceuticalOutsourcingQ42020 - 15
PharmaceuticalOutsourcingQ42020 - 16
PharmaceuticalOutsourcingQ42020 - 17
PharmaceuticalOutsourcingQ42020 - Supply Chain
PharmaceuticalOutsourcingQ42020 - 19
PharmaceuticalOutsourcingQ42020 - Contract Manufacturing
PharmaceuticalOutsourcingQ42020 - 21
PharmaceuticalOutsourcingQ42020 - Interview with Yourway
PharmaceuticalOutsourcingQ42020 - 23
PharmaceuticalOutsourcingQ42020 - Supply Chain
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PharmaceuticalOutsourcingQ42020 - Clinical Trials
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PharmaceuticalOutsourcingQ42020 - Roundtable
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PharmaceuticalOutsourcingQ42020 - Supply Chain
PharmaceuticalOutsourcingQ42020 - 37
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PharmaceuticalOutsourcingQ42020 - Analytical Testing
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PharmaceuticalOutsourcingQ42020 - Supply Chain
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PharmaceuticalOutsourcingQ42020 - Clinical Trials
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PharmaceuticalOutsourcingQ42020 - Analytical Testing
PharmaceuticalOutsourcingQ42020 - 52
PharmaceuticalOutsourcingQ42020 - 53
PharmaceuticalOutsourcingQ42020 - Horizon Lines
PharmaceuticalOutsourcingQ42020 - 55
PharmaceuticalOutsourcingQ42020 - 56
PharmaceuticalOutsourcingQ42020 - 57
PharmaceuticalOutsourcingQ42020 - Industry News
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PharmaceuticalOutsourcingQ42020 - 61
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PharmaceuticalOutsourcingQ42020 - 63
PharmaceuticalOutsourcingQ42020 - Advertiser's Index
PharmaceuticalOutsourcingQ42020 - Cover3
PharmaceuticalOutsourcingQ42020 - Cover4