You are on page 1of 7

+ + + + + + + + + + + + + + +



2003 2017



+ + + + + + + + + + + + + + +
Chapter Six
The Supply-Chain
Management Perspective
Managing Risks and
Guarding Against Disruption

S. Anne Montgomery

B i o P r o c e s s STATE OF THE INDUSTRY

The Supply-Chain Management

Managing Risks and Guarding Against Disruption

S. Anne Montgomery

ll the people and departments
described elsewhere in this
special issue depend on having
the raw materials and
available components and resources to
do their work. Raw materials must be
maintained in quantities sufficient for
their use where and when they will be
needed. When biopharmaceutical
materials must be stored for a time or
transported elsewhere, such as to a
testing lab or manufacturing/ ADOBE STOCK (HTTP://STOCK.ADOBE.COM)

distribution facility, environmental

conditions must be monitored during storage, and distribution and also As former BPI author Russ Hager
transport. These and other logistical to guard against circulation of (BioStorage Technologies) put it,
elements are critical throughout counterfeit biopharmaceuticals Cold-chain management defines how
biopharmaceutical development and the establishment of partnerships temperature-sensitive materials are
manufacturing, They continue to between manufacturers and suppliers/ packaged, transported, and stored
support a product throughout its CDMOs to supply raw-materials and throughout a clinical research process.
lifetime. key components throughout a Any weak link in the chain can
Industry forces shaping todays products lifetime compromise drug or sample integrity,
supply-chain management are much an upsurge in partnerships for breach security, delay shipments, and
the same as the forces currently outsourcing drug development and ultimately lead to financial loss or
transforming other departments (and production (in this case, logistics liability. Moreover, consider the
the biopharmaceutical industry as a partnerships) repercussions of a clinical-trial sample
whole). Supply-chain managers face From the supply chain, then, to the being lost in transit or rendered
an increasing complexity of cold chain, the logistical complexity useless because of temperature
product portfolios and increasing increases. Most biopharmaceutical excursion during transport. That
competition, especially for bringing formulations must be stored at colder- could have a trickle-down effect that
biosimilars and niche formulations to than-room temperatures, and those may delay studies, thereby increasing
market key environmental parameters must be the time to drug approval and
expanding globalization into maintained throughout shipment to reducing the potential time a drug is
emerging regions of bioprocessing and storage at other sites. And as the on the market. He points out that a
the impact of the quality by complexity of the supply chain delay to market could cost a sponsor
design (QbD) initiative on advances in increases to include emerging millions of dollars in potential sales.
real-time monitoring and control of therapies, personalized formulations, So it is vital for clinical-trial
environmental conditions during and multiproduct manufacturing, materials to be packaged and shipped
manufacturing and shipment maintaining the needed storage in compliance with industry and
the emerging stringency of conditions for drugs with differing government standards and to be
labeling and serialization requirements environmental needs places a strain on closely monitored by properly trained
to ease identification during shipment, inventory management. individuals (1).

2 BioProcess International 15(6) Chapter 6 of 11 State of the Industry 2017

Key Issues from The first BPI article to start throughout the supply chain. Now,
Survey Respondents looking at risk-based approaches to process cold-chain management is a
Although very few of our 300 self- supply-chain management was by burgeoning industry: Monthly
selected survey respondents addressed Rick Johnston, then a member of UC seminars on the subject are led by
this particular category, the responses Berkeleys Center for experts in the field, and new
helped indicate what to highlight in Biopharmaceutical Operations as well companies, associations, and trade
this anniversary review. Respondents as the Industrial Engineering and organizations that solely serve this
agreed, some strongly, that logistics- Operations Research department (now niche (3).
and supply-chain managers are seeing with QuintilesIMS) (2). Although he Four years later (2012), Russ Hager
greater emphasis on lifecycle didnt refer to QbD by name, he of BioStorage Technologies, addressed
approaches (including procurement, stressed that An emerging challenge evolving approaches to cold-chain
storage, and inventory management for biotech companies is management that provided strategic
for the life of a product) understanding the bigger picture and advantages to companies in
increased efforts under way to outlined a needed collaborative optimizing their clinical-trial supply
create supplier change-notification approach with other departments to chains (1). His proposal of a holistic
processes again, for better lifetime take advantage of operational approach encompassed the combined
management of product quality efficiencies and reduce costs. factors of understanding regulations
increased attention to contingency Similarly, Eric Isom, at that time and customs requirement (and
planning through use of multiple warehouse operations for Sentry schedules), training and compliance,
suppliers and extended supply-chain Logistic Solutions (now senior director packaging and shipping controlled-
coordination with contractors commodity management, operations, temperature materials, labels and
coordination of supplies to and supply chain, Seagate documentation formats, temperature
secondary sites for regional markets Technology), emphasized monitoring, and international
a greater focus on the composition understanding the special needs of transportation regulations.
of materials used in stoppers/closures biopharmaceutical products and raw Developing Holistic Perspectives:
and delivery devices to prevent their materials, including knowing the In parallel with early struggles to place
leaching into the drug product during regulations and taking advantage of QbD into our universe, however, other
conditions of processing, shipment, existing distribution models (3). His authors were beginning to look at
and storage vision was of a new model of shared- related issues of new approaches to
improved understanding about user logistics wherein a service data management and to suggest a
logistical needs related to shipping provider spreads infrastructure, holistic view of supply-chain logistics
itself and specific to needs of administration, and overhead costs that enabled better handling of shared
biopharmaceuticals among its clients, providing each one data. Pietro Forgione, biopharmaceutical
a positive expectation of the with significant cost savings. business development manager for ID
effect of labeling and serialization It is odd to look back at discussions Business Solutions Ltd. (IDBS), stressed
technologies/protocols of risk management before our current that many organizations lack a reliable
an interest in automated systems understanding of QbD. But with the and accessible method of
for supply-chain management that overall emphasis on quality and the communicating and distributing
might help relieve some uncertainties need to manage increasing complexity/ collaborative information to
of demand/projections. interdependencies, it is clear how the departments involved in the process
These and other aspects of supply- industry had been poised to lifecycle . . . . Todays lack of easily
and cold-chain logistics are incorporate the tools weve seen retrievable contextual process data
summarized below, looking at issues emerge since those earlier papers. from development through to
most relevant to BPI readers. Cold-Chain Issues: In his 2008 manufacture hinders adherence to
perspective, Isom pointed out that PAT and QbD guidelines, both of
Evolution of Supply-Chain cold-chain management also had been which aim to foster a culture of doing
Logistics undergoing increasing scrutiny. Five things right the first time (4). He
A review of BPIs archived articles to ten years ago, cold-chain proposed a data-management solution
reveals a noticeable change in management was still a buzzword in to create a more efficient, continuous
biopharmaceutical supply-chain the industry, and only a few improvementled approach to drug
logistics before and after the companies focused on this effort. The development and manufacturing in
introduction of the quality-risk industry realized that shipping line with the FDAs current good
management paradigm. It also reveals temperature-sensitive products was a manufacturing practice (CGMP)
how logistics management, along with unique problem because temperature guidelines, the benefits of which are
the rest of the industry, had for a time could be affected by many factors reduced manufacturing costs,
figuratively spun its wheels before (such as the carrier, the route, and improved speed to market, and
settling into guidelines for adopting delivery times). That created the need potentially less frequent regulatory
new risk-based practices. to control thermal variability inspections.

3 BioProcess International 15(6) Chapter 6 of 11 State of the Industry 2017

By contrast, articles from 2015 to supply chains. The supply chain flawed even before that planning
the present take such collaborative and operates on two levels. Strategically it begins?
holistic practices in stride, although is a business process, and operationally Risk assessment and strategy
much training is still needed in how it is a value stream. In reference to development begin with a few vital
to manage data points to support risk- the importance of guarding against questions:
management and control strategies. In the terrorism of counterfeit and At what temperature does your
addition, publication of ICH Q11 adulterated drugs and resulting loss of product need to be transported and
addressed the need for more stringent public confidence, they wrote, stored?
protections against sourcing-derived competition, globalization, Where does the drug need to go
problems (5). innovation, and regulations drive international or domestic
Managing a Clinical Supply Chain: traditional risk. Terrorism, however, is market(s)?
In 2016, Jens Mattuschka of Paraxel an unusual adversary because its During what season(s) will the
pointed to four dimensions perpetrators are neither competitors product be distributed?
services, time, cost, and flexibility nor simple criminals. In this regard, What stability data are available?
that must be balanced and can be the supply chain is an Achilles heel What are the size, mass, and dose
supplemented by supply strategies that proactive organizations must format of the drug?
implemented for single projects (6). In struggle with, especially those How is it packaged?
focusing on managing uncertainties in involved in the food and drug How much of an investigational
a clinical supply chain, he stressed the industries. Supply chains are medicinal product (IMP) can each
importance of vulnerable to internal and external intended site receive and store safely
integrated trial planning (e.g., breach as well as physical and from a single shipment?
variables determining numbers of nonphysical threats. Individual Davidson concludes that Risk
subjects) segments, separated by time and assessment and contingency planning
logistics data (qualitative distance, often operate beyond the are valuable company assets, but being
information such as import and export reach or control of those responsible realistic is the most important factor.
regulations as well as local and on-site (7). No amount of planning will protect a
logistics infrastructure may exclude A number of BPI authors have companys reputation if its proverbial
certain countries or hospitals from the stressed the need for careful car is missing a wheel before ever
selection process) contingency planning for business leaving the driveway.
materials (which analyses are continuity: A crucial focus of supply- Business Continuity: In a 2008
needed, how often, and where) chain (and cold-chain) logistics. paper, Eize de Boer described
and logistics strategy and In 2013, Stuart Davidson of investigations of a supply-chain
associated risk management Intelsius LLC wrote that, In the incident related to recalls of
(mentioning that reducing silo United States, up to 40% of businesses PedvaxHib and Comvax vaccine
mentality also reduces costs). affected by a natural or human-caused batches and urged the importance
When biopharmaceutical research disaster never reopen. The of a QbD approach (9). Combining
and development companies closely biopharmaceutical industry is not the principles of aseptic processing
integrate key supply chain providers immune from disasters of a dizzying with a quality risk assessment
into planning, execution, and variety. But biotechnology companies approach, as called for by the new
technical and quality perspectives, often put all their supply needs in one regulatory guidance, will make for an
those companies tend to be much proverbial basket. Companies need to important contribution to the safety
more successful. Those providers can understand fully the ramifications of and quality of todays vaccines. . . .
be CMOs, central laboratories and contingency planning for single The new guidance on aseptic
logistics providers, and/or clinical product lines. . . . Switching to a processing (annex 1 of the EU GMP
trialconducting clinical research simpler, more efficient, temperature guide) contains a detailed description
organizations (CROs). By contrast controlled shipping solution will of how to minimize microbial
with other industries, many improve both aspects of the companys contamination. Validation of the
biopharmaceutical clinical supply bottom line (8). filling operation is now clearly defined
chain providers are still miles away He points out that risk assessment with precise statistics on the number
from fast-moving product cycles of and management are the most fluid of containers that are allowed to show
todays market (6). of planning tools, needed for every positive growth during a fill
branch of a company around the simulation test, with action limits set
Risk Management: world. Results will be unique at multiples of one out of each
Contingency Planning depending on the possible risks and 10,000.
In their 2009 article, consultants flexibility required to continue For business continuity in clinical-
James Noferi and Ralph Dillon business with little or no interruption. trial manufacturing, Jens Mattuschka
offered one of BPIs first cautionary What if your company has the best (vice president) and Vincent Santa-
analyses of the vulnerabilities of contingency plan, but a system is Maria (senior director of clinical

4 BioProcess International 15(6) Chapter 6 of 11 State of the Industry 2017

logistics services) at Parexel tools for identifying critical raw
Cell Therapy Supply Chains
International, emphasize the material attributes (13). Cell-therapy companies also are facing
importance of risk-mitigation and Much recent discussion in the questions about how to create supply
contingency planning in storage and biopharmaceutical industry related to chains to handle the complex isolation
distribution of clinical trial material change-control documentation is and tracking of large numbers of
individual patient lots. BPI has published
(10). A holistic view of storage, coming from those who make or
a number of papers touching on this
distribution, and handling of specify single-use films and products.
aspect of cell-therapy manufacturing
deviations is essential for optimizing With more production and and distribution. Such companies have
costs and ensuring product safety. manufacturing worldwide becoming contributed insight into how complex
Equally important is a distribution dependent on the efficiencies of supply and distribution networks might
that ref lects product stability and single-use systems, the risk of major be established building on
requirements of all countries delays in production and distribution established resources at blood-
involved. Even when supply chain is increased if a critical plastic is collection centers for collection, storage,
management is outsourced, the discontinued or its formulation and delivery.
results are ultimately the changed beyond a sponsors product For example, Dan ODonnell (Fisher
responsibility of a drug products specifications. Authors from Pall Bioservices) wrote about cell therapy
sponsor company. Both sides of a Corporation, a company that has logistics, delving into lesser-known
contract relationship need to aimed to reduce supply-chain risks for considerations of standardization,
understand logistics. its manufacturing partners by package and shipping qualification,
storage equipment validation, process
Althrough details of shipping and developing its own line of bags and
qualification, and documenting the
customs regulations and good components, detailed examples of
chain of custody (1). And Lisa Shaffer,
distribution practices (GDP) robust change control and business senior vice president of Blood Centers of
requirements are too numerous to continuity planning for raw materials America, spoke about best supply-chain
offer here, a useful place to begin and components up to final single-use practices learned from blood centers (2).
related to facility/premises, equipment, products are guaranteed by long-term 1 ODonnell D. The Cell Therapy Supply
operational qualification, storage, and supply contracts and quality Chain: Logistical Considerations for
order fulfillment and export can be agreements with all critical suppliers Autologous Immunotherapies. BioProcess Int.
found in guidelines dating from 2013 and partners (14). They stressed that 13(9)s 2015: 3944.
(11). assurance of supply should be built 2 Shaffer, L. Best Practices in Supply
Chain Logistics: How Blood Centers
Managing Supply-Chain Disruption: from close partnerships, supply
Participate in Collection, Storage, and
The biopharmaceutical industry can contracts, quality agreements, and Delivery of Cell Therapies; www.
draw from recent examples of crises in transparency to provide control over
supply-chain continuity. In BPI, an entire manufacturing process. practices-supply-chain-logistics-blood-
Guenter Jagschies and coauthors wrote Single-use supply chains require centers-participate-collection-storage-
how GEs comprehensive risk in-depth material science and film
mitigation program enabled proactive expertise to achieve consistent quality
management of the crisis caused by attributes for plastic film, bags, and
the 2011 tsunami in Japan. Their final, sterile single-use assemblies. Flexsafe bags are designed with a
example was of the need to address a They describe how their companys complete understanding and control
resulting shortfall of a raw material for robust change-control system in their of the bag manufacturing process
chromatography media used in case allows a comfortable time period from resin and film extrusion to final
Sephacryl chromatography media (12). of up to four years for assessing and sterile bioprocessing bags. The
studying the effects of changes on end company establishes specifications,
Control Strategies and users. With proper validation and travelability, and control of resins and
Managing Secondary Suppliers understanding of resin critical quality additives as well as definition of a
In the case of having to substitute a attributes, releasing and controlling design space for fill extrusion. The
secondary source of raw materials or resins with specifications, not trade goal is to provide long-term supply
components, a CMC Forum names, enhances the quality of films, assurance, consistent product
consensus paper from 2009 discussed facilitates change management, and performances, and robust change
how strategies for raw material control improves long-term assurance of control as well as flexibility in
are evolving within changing supply. That allows for fast business continuity planning . . . by
regulatory and business paradigms, implementation of alternative resin establishing back-up equipment for
including quality by design, suppliers in the unlikely event of resin cracking and film extrusion,
counterfeiting threats, complex supply change or discontinuation of some raw multiple bag manufacturing locations,
chains, and sourcing changes. That materials. and safe stock of resins and extruded
forum included supply-chain Pall has focused a great deal of film rolls (15).
contingency planning in its focus on attention on the importance of Although not all industry
how to implement risk assessment business continuity planning. Its spokespeople have been eager to

5 BioProcess International 15(6) Chapter 6 of 11 State of the Industry 2017

launch into the complexities of Operations Group (BPOG) and the company to resist introducing changes.
managing alternative suppliers and Bio Process Systems Alliance (BPSA). Therefore, supply chain and
sources, secondary sourcing does seem The culmination of these discussions distribution have become much bigger
to have caught on as an industry best is an article in BPIs May 2017 issue parts of technology transfer project
practice. In his 2015 BPI article, summarizing key points from the management. Because of this,
Yuval Shimoni (principal engineer, groups white paper. In that summary, transportation, serialization, and the
Bayer LLC) stresses that concerns Jeffrey Carter and coauthors highlight complexity of data management all
about events that cant be controlled elements of customer expectations, have become much bigger issues.
by either partner (e.g., natural attributes of an effective change Other changes foreseen for the greater
disasters) may make it prudent to notification practice, categories of pharmaceutical industry with
consider a second material source. change, change and prechange application to biologics include full
Safety stocking is notbest or possible notification content, and change integration of companies in emerging
for all raw materials (RMs). For notification workflow. The full text of markets into a global supply chain
example, physical space constraints this white paper is available at those and, with that, creation of global
and/or working-capital burdens may organizations websites (24), and other inventory management systems. And
preclude keeping a stock in house. In a useful insights are available in two in supply-chain management as well
few instances, such considerations podcasts on the BPI site (25, 26). as other areas of the biopharmaceutial
make it appropriate instead to qualify industry, future automation systems
a second-source supplier as the top Labeling and Serialization might be able to predict needs based
priority (16). He goes on to explain and Automation? on big data and cloud-based tracking
that When second-source We know how supply-chain variability resources.
qualification is determined to be best can compromise business continuity, In a 2016 article, Mike Ward of
for multiple RMs (but qualifying and this includes variability from Loftware introduced BPI readers to
them all at once is infeasible), using a labeling errors stemming from manual enterprise labeling solutions for
prioritization decision matrix is processes. A final point about todays addressing variability in product
helpful. A weighted scoring system is approaches to supply-chain logistics is labeling. Adding to the complexity of
based on five criteria in decreasing the integration of harmonized drug-product labeling, companies face
weight: quality risk (can be activities toward managing complex a broad range of evolving
determined based on historical global supply chains. The complexity requirements. Those include regional,
incidents), supply assurance risk, of sourcing and distribution can lead a language, customer, and regulatory
sustainable volume for dual source, requirements that must be met quickly
ease of qualification, and cost. This A Serialization Example and efficiently to prevent supply-chain
exercise produces a prioritized list of disruption. Companies that cannot
RMs for which a second source is to Covectra, a serialization, authentication, meet those requirements can end up
and track and trace technology services
be qualified. with fines, dissatisfied customers, and
provider, has launched its patented
Guarding Against Contamination:
StellaGUARD security label. The label,
loss of business. Enterprise labeling
Another issue that is an extensive which is embedded with stars arranged solutions allow drug makers to deal
topic in itself is how to evaluate the in unique and random patterns and with variability in labeling by
risks of viral contamination and other contains a serialized GS1 2D barcode, providing label formatting that
particles and contaminants in enables real time authentication and supports myriad different label
bioprocess supply chains. A number of serialized pedigree tracking through the combinations with a minimum
BPI authors have offered details about use of a mobile app developed by the number of label designs (27).
such strategies (1720), and three company. The industrys phasing-in of
examples of regulatory guidelines The label, which can be applied to serialization requirements reflects
specific to virus mitigation in raw practically any package and material, heightened concerns for protecting
materials are offered here for reference was developed in anticipation of the product safety and traceability through
(2123). EUs 2019 Falsified Medicines Directive a products lifetime. A white paper
requirement for tamper evident seals on from Vetter explains how that CDMO
all pharma and over-the-counter (OTC )
Change Control Practices: incorporates serialization (28). With a
primary packages. The security label is
Increasing Collaboration integrated with Covectras EPCIS
unique identifier, each package is
The topic of supplier-change Certified AuthentiTrack database, which protected from counterfeit drugs
notifications specific to use of single- now is managing over two billion serial while improving transparency in a
use materials deserves a section of its numbers. This enables the StellaGUARD companys internal and external supply
own. Practical guidelines are emerging label to be used not just for rapid chain. That makes potential recalls
for change-control and qualification of authentication, but also for diversion easier and helps control inventory.
single-use systems (SUS). detection and isolation. These authors stressed the need to
Spearheading these discussions is a For more information, please go to have the IT infrastructure to support
group representing the BioPhorum upgrading to serialization and to still

6 BioProcess International 15(6) Chapter 6 of 11 State of the Industry 2017

respond flexibly to customer 10 Mattuschka J, Santa-Maria V. A does/ en_GB/document_library/scientific_
Critical Mission: Clinical Trial Material guidance/2009/09/wc500003684.pdf.
Storage and Distribution. BioProcess Int. 12(8) 24 Change Notification; www. biophorum.
Two sources of information are 2014: 1217. com/change-notification and www.bpsalliance.
useful for learning about serialization 11 Guidelines of 5 November: Good org (in press).
approaches in our industry. Directive Distribution Practice of Medicinal Products for 25 Priebe P. Innovative Raw Material
2001/83/EC provides for measures to Human Use. Off. J. European Un. 3 November Management and Product Design Strategy for
prevent the entry into the legal supply 2013: Enhanced Quality, Assurance of Supply,
documents/european_good_distribution_ Validation, and Change Control of Single-Use
chain of falsified medicinal products by
practice_guidelines_5_november_2013.pdf. Systems (Video);
requiring the placing of safety features
12 Jagschies G,Westman D, Raw D. sponsored-content/innovative-raw-material-
consisting of a unique identifier and an Supply Chain Challenges in the management-and-product-design-strategy-for-
anti-tampering device on the packaging Biopharmaceutical Industry: A Case Study enhanced-quality-assurance-of-supply-
of certain medicinal products for Following the 2011 Tsunami in Japan. validation-and-change-control-of-single-use-
human use for the purposes of allowing BioProcess Int. 12(8) 2014: 18 22, 73. systems.
their identification and authentication. 13 Beck G, et al, Raw Material Control 26 Kapp T. Regulatory Compliance in
Strategies for Bioprocesses. BioProcess Int. 7(8) Single-Use BioManufacturing Facilities
This safety feature will determine
2009: 1829. Requires a Collaborative Approach with your
characteristics and technical Supply Chain;
14 Cappia J-M, et al. Outsourcing to
specifications of a unique identifier, the Enhance Assurance of Supply: Application of bpi-theater/regulatory-compliance-single-use-
modalities for the verification of the Counterintuitive Supply Chain Strategies A biomanufacturing-facilities-requires-
safety features, and the establishment Case Study. BioProcess Int. 14(5)s 2016: 2023. 27 Ward M. Addressing Variability in
and management of the repository Product Labeling: Explore Dynamic Labeling
for Your Global Enterprise. BioProcess Int. 14(4)
system containing information on the 15 Cappia, J-M, et al. Enhanced Assurance
2016: 76.
safety features (29). It details the of Supply for Single-Use Bags: Based on
Material Science, Quality By Design, and
nature of the proposed coding and
Partnership with Suppliers. BioProcess Int. 12(8) 28 Ask the Expert. Secondary Packaging:
identification to prove authenticity. s 2014: 4326. Creating Value with Product Lifecycle
The emerging labeling requirements 16 Shimoni Y, Srinivasan V, von Management. Vetter (white paper); http://
also are elucidated in EU Medicinal Gruchalla-Wesierski M. A Risk-Based
Products for Human Use, Falsified Approach to Supplier and Raw Materials uploads/2015/06/13-6-Vetter-Insert.pdf.
Medicines (30). Management. BioProcess Int. 13(10) 2015: 29 Directive 2001/83/EC of the European
1015. Parliament and of the Council of 6 November
17 Shimoni Y, et al. Viral Risk Evaluation 2001 on the Community Code Relating to
References of Raw Materials Used in Biopharmaceutical Medicinal Products for Human Use (2004);
1 Hager R. The Global Cold Chain.
Production. BioProcess Int. 14(9) 2016: 2230.
BioProcess Int. 10(10) 2012: 2428, 65. files/eudralex/vol-1/reg_2016_161/
18 Masser D, Chandarana N. Controlling
2 Johnston R. Reconsidering the Supply reg_2016_161_en.pdf.
Particulates Through a Supply Chain; www.
Chain. BioProcess Int. 6(5) 2008: 72. 30 Falisified Medicines. EU Medicinal
3 Isom E. Requirements for Outsourced particulate-through-a-supply-chain. Products for Human Use. European
Cold Chain Logistics and Storage in
human-use/falsified_medicines_en. c
19 Toro A, et al. Setting Raw-Material
Biopharmaceutical Development. BioProcess Int.
Specifications Using Prediction Models:
9(8) 2006: 4850.
Determination of a Specification Limit for a
4 Forgione P. Data Management in the Raw-Material Impurity in mPEG-Aldehyde.
Supply Chain. BioProcess Int. 10(9) 2008: BioProcess Int. 15(1) 2017: 4043. S. Anne Montgomery is cofounder and
2026. editor in chief of BioProcess International,
20 Wisher M. Virus Risk Mitigation for
5 ICH Q11. Development and Manufacture Raw Materials: A European Perspective.
of Drug Substances (Chemical Entities znd BioProcess Int. 11(9) 2013: 1215, 39.
Biotechnological/Biological Entities); www.ich. This is an extended version of the article
21 Guideline on the Use of Bovine Serum in
the Manufacture of Human Biological Medicinal published in BPIs June 2017 print issue.
Products. EMA/CHMP/BWP/457920/2012
rev. 1;
6 Mattuschka J. Clinical Supply Chain: A To share this article in a PDF or professionally
document_ library/Scientific_
Four-Dimensional Mission. BioProcess Int. 14(3) printed format, contact Rhonda Brown,
guideline/2012/09/ WC500133066.pdf., 1-866-879-9144
2016: 1617.
22 Guideline on the Use of Porcine Trypsin x194.
7 Noferi JF, Dillon RL. Defending the Used in the Manufacture of Human Biological
Supply Chain: Lessons from Sun Tzu. Medicinal Products. EMA/CHMP/
BioProcess Int. 7(1) 2009 1017, BWP/814397/2011;
8 Davidson S. Risk Assessment and en_GB/document_ library/Scientific_
Business Impact Analysis of the Supply Chain: guideline/2013/03/ WC500139532.pdf. 5
A Cautionary Tale in Contingency Planning. Kurth A, et al.
BioProcess Int. 11(1) 2013: 12 17. 23 Note for Guidance on Viral Validation
9 de Boer E. Optimizing Vaccine Supply Studies: The Design, Contribution, and
Chains Through Quality Management in Intepretation of Studies Validating the
Manufacturing. BioProcess Int. 6(10) 2008: Inactivation and Removal of Viruses. EMA/
3840. CPMP/BWP/208/95; www.ema.europa.en/

7 BioProcess International 15(6) Chapter 6 of 11 State of the Industry 2017