Click here to view this email in your browser
American Peptide Company

New President/CEO
 
Mr. Minoru Sakakibara is our new President and CEO. His predecessor, Takahiro Ogata, has been promoted to CEO of ILS Inc., the parent company of American Peptide Company. Mr. Sakakibara was previously part of the Senior Management of Otsuka Chemical Company where he worked in the Corporate Strategy Department. Takahiro Ogata said, "Mr. Sakakibara has the experience and vision to guide American Peptide Company as they grow and increase their peptide manufacturing capacity."
 
 
 
 
Events

AAPS Annual Meeting and Exposition (Washington DC)
10/23-27, 2011 (booth #1443)
 
CPhI Worldwide
(Frankfurt, Germany)
10/25-27, 2011 (std #50F63)
 
Neuroscience 2011
(Washington DC)
11/12-16, 2011 (booth #519)
 
NCRI Cancer Conference (Liverpool, UK)
11/6-9, 2011 (booth #58)
 
American Society for Cell Biology (Denver, CO)
12/3-7, 2011 (booth #822)
 
 
In the News

European Biopharmaceutical Review
October 1, 2011
 
 
 
Peptide Word Puzzle
 
Find the hidden peptide word in the 96 well plate below. The word may be written forward, backward, horizontally, vertically, or diagonally. The first five people to find the hidden peptide word win a $10 Amazon gift card! Email your answers to: apc@americanpeptide.com.
 
b
a
t
k
n
a
t
j
u
z
f
i
v
h
m
c
e
h
n
r
j
a
e
y
l
w
t
o
g
s
r
w
p
e
r
c
u
d
r
o
c
g
h
r
e
l
i
n
x
s
i
d
m
q
f
r
t
p
h
e
y
u
i
e
i
d
g
s
i
b
e
f
f
i
m
d
e
i
l
k
s
t
e
l
a
v
d
o
d
e
s
n
m
i
w
p
Peptide Wire - Edition 6 (October 2011)
 
Quality Considerations for Peptide Manufacturing Processes
 
As peptide-based therapies are increasingly becoming viable drug discovery and development targets, the industry is paying more attention to the quality concerns that underlie peptide manufacturing processes. Peptide synthesis for pharmaceutical manufacturing can be tedious and time-consuming given the complexity of the product and the lengthy, intricate synthesis process. Regulatory compliance, quality control and quality assurance efforts are critical for the successful development and manufacture of peptides as active pharmaceutical ingredients (APIs). As a key element in the peptide production process, quality should be built into every step, and thought of as process parameter, not a process outcome.
 
Achieving product quality and purity requires a meticulous quality-centric approach from discovery to the final release of the product. While the notion of quality encompasses all activities designed to ensure adequacy of manufactured products, the protocols for the pharmaceutical industry are usually divided into two separate functions, quality assurance (QA), which oversees the entire manufacturing process and is responsible for the final release and disposition of the product, and quality control (QC), which is responsible for analytical testing and characterization of raw materials and finished products. Essentially, QC monitors the endpoints of a production run: what comes in and what goes out. QA, by contrast, is responsible for quality throughout the entire manufacturing process.
 
The analytical chemists who are responsible for QC also ensure that analytical methods are developed and subsequently validated. Their assessment of structural integrity and purity of the peptide is critical during the development stages of a product. Without rigorous analytical characterization and evaluation of potential impurities at the start of each manufacturing project, problems may be missed only to resurface at a later point in the process - often as product recalls and sometimes with devastating consequences on patient health and safety.
 
A Quality System is the Sum of its Parts
 
A quality system in a pharmaceutical manufacturing environment is comprised of several components, including, but not always limited to facilities and equipment, laboratory controls, materials, packaging and labeling. These components should be designed to incorporate redundancies and fail-safes, because failure of one component can mean failure of the entire operation.
 
The facility and equipment component is a critical part of overall quality management, requiring consistent monitoring, maintenance and validation and possibly a need for calibration. Regular evaluations of the humidity, ventilation, and air-control (HVAC) system, compressed gases and water systems are important. These facility- and equipment-specific considerations should be addressed during facility design and continually improved upon as needs evolve.
 
Staying in Compliance with a Focus on Quality
 
A focus on quality must have as its ultimate goal - regulatory compliance. Adherence to current good manufacturing practices (cGMPs) and a robust documentation program can ensure reproducible, verifiable quality procedures that stand up to regulatory scrutiny as well as guarantee a high purity final product.
 
The U.S. Food and Drug Administration mandates cGMPs, obligatory prerequisites to establishing a robust and reproducible manufacturing process. Apart from general guidelines, including the Code of Federal Regulations (CFR) and ICH (Q7A) Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients, there is only one guideline specifically dedicated to peptides. "Guidance for Industry for the Submission of Chemistry, Manufacturing, and Controls Information for Synthetic Peptide Substances," issued in 1994, stipulates that the lot-release specifications - a set of tests and acceptance criteria that must be met before product is released - must be sufficient to ensure the identity, purity, strength and/or potency of the peptide and to demonstrate lot-to-lot consistency.
 
Every product manufactured under cGMP must undergo a battery of analytical tests. Each batch should be provided with a lot-specific certificate of analysis (CoA) documenting specifications, test methods and results. A typical CoA contains information on appearance, solubility, purity by gradient HPLC, molecular weight, along with peptide counter ion, water, and residual organic solvent content.
 
This article will be continued in the next edition of The Peptide Wire.
 
Headquarters: 777 East Evelyn Ave. Sunnyvale, CA 94086 USA
Toll Free: 800-926-8272 • Phone: 408-733-7604 • Fax: 408-733-7603
 
cGMP Manufacturing: 1271 Avenida Chelsea Vista, CA 92081 USA
Toll Free: 800-926-8272 • Phone: 760-597-8820 • Fax: 760-597-8816
 
APC Europe: 43 Lime Tree Road, Matlock, Derbyshire DE4 3EJ UK
Phone: +44-1629-582441 • Fax: +44-207-117-3575
 
 
Please follow the instructions below if you wish to be removed from our email list.
© 2011 American Peptide Company, Inc.