APR March 2021 - 12

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MANUFACTURING

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Continuous Manufacturing
Enables Speed
of Development
and Commercialization
Ahmad Almaya, PhD
Director of Global Regulatory Affairs

Joshua Hanson, PE
Associate Senior Consultant Engineer
Lilly Research Labs, Eli Lilly and Company

12 |

| March 2021

Introduction
Conventional pharmaceutical manufacturing is based on batch
manufacturing processes which are robust and have been producing
high quality materials for decades. However, batch manufacturing
processes contain numerous, disconnected steps; exhibit significant
scale changes throughout development and commercialization; and
typically involve product testing after manufacturing is finished.
With Continuous Manufacturing (CM), processes could be designed
such that there is constant material flow in and out of the process.
While CM is already established in several industries including
petrochemical, food and polymer industries, it is relatively new
in the pharmaceutical industry. CM use in the pharma industry is
growing as it provides several opportunities for improvements.
A few pharmaceutical unit operations are already continuous, by
design. Examples include tablet compression operations, milling
operations and others. However, adoption of CM in pharmaceutical
manufacturing impacts to a large extent the integration of individual
unit operations, and such integration allows for a number of business
and technical opportunities with CM that are not allowed for with
conventional batch processes.
This integration of unit operations with CM is very different from
established batch manufacturing operations where a significant
amount of time may elapse in between subsequent unit operations.
For example, dispensing operations may take place days or weeks
ahead of the start of manufacturing, and days or weeks may also
elapse between subsequent processing steps until the final product
is produced with batch processes. On the other hand, CM allows for
integration of several unit operations such that processing across
the entire manufacturing train could be taking place at the same
time. In that manner, input raw materials can be continuously fed
into the CM train, all unit operations are integrated and operational,
and finished product is continuously produced out of the system.
This integration also allows for new methodologies to be applied
to some of the unit operations to allow for such integration. The
most prominent examples of this are the dispensing and blending
operations which leverage newer equipment designs and allow for
improved process controls than their counterparts in conventional
batch manufacturing operations.



APR March 2021

Table of Contents for the Digital Edition of APR March 2021

Editor's Message
Editorial Advisory Board
CN Perspectives
Social Media Connections
Manufacturing
Microbiology
Equipmet Focus
Microbiology
Vendor Viewpoint
QC Corner with Millipore Sigma
Manufacturing
Biopharmaceutical Development
Biopharmaceutical Development
Manufacturing
Microbiology
Manufacturing
Separation and Purification
P.I.N. Points
Advertiser's Index
APR March 2021 - Cover1
APR March 2021 - Cover2
APR March 2021 - 1
APR March 2021 - 2
APR March 2021 - 3
APR March 2021 - 4
APR March 2021 - 5
APR March 2021 - Editor's Message
APR March 2021 - 7
APR March 2021 - Editorial Advisory Board
APR March 2021 - 9
APR March 2021 - CN Perspectives
APR March 2021 - Social Media Connections
APR March 2021 - Manufacturing
APR March 2021 - 13
APR March 2021 - 14
APR March 2021 - 15
APR March 2021 - 16
APR March 2021 - 17
APR March 2021 - 18
APR March 2021 - 19
APR March 2021 - Microbiology
APR March 2021 - 21
APR March 2021 - 22
APR March 2021 - 23
APR March 2021 - 24
APR March 2021 - Equipmet Focus
APR March 2021 - Microbiology
APR March 2021 - 27
APR March 2021 - 28
APR March 2021 - 29
APR March 2021 - 30
APR March 2021 - 31
APR March 2021 - 32
APR March 2021 - Vendor Viewpoint
APR March 2021 - 34
APR March 2021 - 35
APR March 2021 - QC Corner with Millipore Sigma
APR March 2021 - 37
APR March 2021 - Manufacturing
APR March 2021 - 39
APR March 2021 - 40
APR March 2021 - 41
APR March 2021 - Biopharmaceutical Development
APR March 2021 - 43
APR March 2021 - 44
APR March 2021 - Biopharmaceutical Development
APR March 2021 - 46
APR March 2021 - 47
APR March 2021 - Manufacturing
APR March 2021 - 49
APR March 2021 - 50
APR March 2021 - 51
APR March 2021 - 52
APR March 2021 - 53
APR March 2021 - 54
APR March 2021 - 55
APR March 2021 - Microbiology
APR March 2021 - 57
APR March 2021 - 58
APR March 2021 - 59
APR March 2021 - Manufacturing
APR March 2021 - 61
APR March 2021 - 62
APR March 2021 - 63
APR March 2021 - 64
APR March 2021 - Separation and Purification
APR March 2021 - 66
APR March 2021 - 67
APR March 2021 - 68
APR March 2021 - 69
APR March 2021 - P.I.N. Points
APR March 2021 - 71
APR March 2021 - Advertiser's Index
APR March 2021 - Cover3
APR March 2021 - Cover4
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