ProThera, Inc. - Nevada Governor`s Office of Economic Development

Board Summary
ProThera, Inc.
Date: March 25, 2016
10439 Double R Blvd., Reno, NV 89521
Dana Bridgman, COO
Manufacturing & Operations - Nutraceuticals
Business Type: Expansion
Main Location: Carson City, Nevada
Development Authority Representative: Nancy McCormick - EDAWN
County: Washoe County
APPLICATION HIGHLIGHTS
- ProThera, Inc. is applying for Sales Tax, Modified Business Tax, and Personal Property Tax abatements.
- Meets statute for job creation, average wage and capital investment levels.
- Existing 112 employees at an average hourly wage of $24.94 prior to expansion plans.
- Additional capital investment of $2,200,000 for building leasehold improvements.
PROFILE
ProThera, Incorporated is a nutritionally-focused healthcare company. It specializes in the research, formulation, and manufacture of nutraceutical products
for exclusive distribution by healthcare professionals. Founded in 2001, ProThera, Inc. has earned a reputation as an innovative, solution-oriented
nutraceutical company. Its products are based on a firm scientific foundation and sound medical research. Flexibility, rapid response, and personalized
attention to the individual needs of healthcare professionals describe its underlying service philosophy. Source: ProThera, Inc.
SIGNIFICANCE OF ABATEMENTS IN THE COMPANY'S DECISION TO RELOCATE/EXPAND
ProThera, Inc. currently manufactures products through third party contractors outside of the state and is evaluating the opportunity to expand operations in
Northern Nevada to include manufacturing. The abatements are a key part in this evaluation to determine if this opportunity would be financially prudent.
ProThera, Inc. would make capital investments of approximately $4.2 million and would plan to hire 25 additional professional and manufacturing
employees from the Northern Nevada area. Source: ProThera, Inc.
REQUIREMENTS
Statutory
Application
Sufficient
% Over / Under
25
$20.89
$65,176
$65,176
25
$23.12
$2,079,520
$2,079,520
Yes
Yes
Yes
Yes
0%
11%
3091%
3091%
Requested Terms
Estimated $ Amount
Abated to 2%
50% for 4 years
50% for 10 years
$119,100
$29,413
$77,813
$226,326
Contracted
24-Month Projection
25
25
12
Land
Building Purchase
BTS / Building Improvements
$0
$0
$2,200,000
Total
Construction
19
$1,138,686
$3,104,299
Job Creation
Average Wage
Equipment CapEx (SU & MBT)
Equipment CapEx (PP)
INCENTIVES
Sales Tax Abmt.
Modified Business Tax Abmt.
Personal Property Tax Abmt.
Total
JOB CREATION
OTHER CAPITAL INVESTMENT
ECONOMIC IMPACT ESTIMATES (10-Year Cumulative)
Total Jobs Supported
Total Payroll Supported
Total Output Estimate
67
$30,493,057
$174,496,106
5-Year Projection
Estimate includes jobs, payroll & output by the company assisted as well as the secondary impacts to other local businesses.
NEW TAX REVENUE ESTIMATES (10-Year Cumulative)
Local Taxes
Property
Sales
Lodging
State Taxes
Property
Sales
Modified Business
Lodging
Total
COST-BENEFIT ASSESSMENT
Direct
Indirect
Total
$1,178,870
$81,868
$0
$912,812
$503,943
$24,595
$2,091,682
$585,811
$24,595
$57,423
$70,190
$151,478
$0
$1,539,829
$47,749
$189,057
$198,058
$709
$1,876,923
$105,172
$259,247
$349,536
$709
$3,416,752
Economic Impact per Abated Dollar
$771
EMPLOYEE BENEFITS
- Percentage of health insurance covered by company: 66%.
- Health care package cost per employee - $7,480 annually with options for dependents.
- Overtime, PTO/Sick/Vacation, Bonus, Retirement Plan, Merit Increases.
NOTES
- Percentage of market outside of Nevada: 99%.
- The company average hourly wage exceeds the statewide average hourly wage of $20.89.
New Total Tax per Abated Dollar
$15.10
Company is an / a: (check one)
New location in Nevada
Incentive Application
Company Name:
ProThera, Inc.
Date of Application:
February 9, 2016
Expansion of a Nevada company
Section 1 - Type of Incentives
Please check all that the company is applying for on this application:
Sales & Use Tax Abatement
Sales & Use Tax Deferral
Modified Business Tax Abatement
Recycling Real Property Tax Abatement
Personal Property Tax Abatement
Other:
Train Employees Now
Section 2 - Corporate Information
COMPANY NAME (Legal name under which business will be transacted in Nevada)
FEDERAL TAX ID #
ProThera, Inc.
88-0487638
CORPORATE ADDRESS
CITY / TOWN
STATE / PROVINCE
ZIP
10439 Double R Blvd.
Reno
Nevada
89521
MAILING ADDRESS TO RECEIVE DOCUMENTS (If different from above)
CITY / TOWN
STATE / PROVINCE
ZIP
TELEPHONE NUMBER
WEBSITE
775-850-8800 ext 1159
www.protherainc.com
COMPANY CONTACT NAME
COMPANY CONTACT TITLE
Dana Bridgman
Chief Operating Officer
E-MAIL ADDRESS
PREFERRED PHONE NUMBER
dana.bridgman@protherainc.com
775-850-8800 x1159
Has your company ever applied and been approved for incentives available by the Governor's Office of Economic Development?
Yes
No
If Yes, list the program awarded, date of approval, and status of the accounts (attach separate sheet if necessary):
Section 3 - Program Requirements
Please check two of the boxes below; the company must meet at least two of the three program requirements:
A capital investment of $1,000,000 in eligible equipment in urban areas or $250,000 in eligible equipment in rural areas are required. This criteria is
businesses. In cases of expanding businesses, the capital investment must equal at least 20% of the value of the tangible property owned by the
business.
New businesses locating in urban areas require fifty (50) or more permanent, full-time employees on its payroll by the eighth calendar quarter following
quarter in which the abatement becomes effective. In rural areas, the requirement is ten (10) or more. For an expansion, the business must increase
the number of
employees on its payroll by 10% more than its existing employees prior to expansion, or by 25 (urban) or 6 (rural) employees, whichever is
greater.
In urban areas, the average hourly wage that will be paid by the business to its new employees is at least 100% of the average statewide hourly wage.
in rural areas, the average hourly wage will equal or exceed the lesser of the county-wide average hourly wage or statewide average hourly
wage.
Note: Criteria is different depending on whether the business is in a county whose population is 100,000 or more or a city whose population is 60,000 or more (i.e.,
“urban” area), or if the business is in a county whose population is less than 100,000 or a city whose population is less than 60,000 (i.e., “rural” area).
Section 4 - Nevada Facility
Type of Facility:
Headquarters
Technology
Back Office Operations
Research & Development / Intellectual Property
Service Provider
Distribution / Fulfillment
Manufacturing
Other:
PERCENT OF COMPANY'S MARKET OUTSIDE OF NEVADA
EXPECTED DATE OF NEW / EXPANDED OPERATIONS (MONTH / YEAR)
99%
Oct-2016
NAICS CODE / SIC
INDUSTRY TYPE
311400
General Business - Nutraceuticals (Dietary Supplements)
DESCRIPTION OF COMPANY'S NEVADA OPERATIONS
Manufacturing/Operations
PROPOSED / ACTUAL NEVADA FACILITY ADDRESS
CITY / TOWN
COUNTY
ZIP
795 Trademark Drive
Reno
Washoe County
89521
WHAT OTHER STATES / REGIONS / CITIES ARE BEING CONSIDERED FOR YOUR COMPANY'S RELOCATION / EXPANSION / STARTUP?
Carson City, Nevada
1
Section 5 - Complete Forms (see additional tabs at the bottom of this sheet for each form listed below)
Check the applicable box when form has been completed.
5 (A)
Equipment List
5 (B)
Employment Schedule
5 (C)
Evaluation of Health Plan
Section 6 - Real Estate & Construction (Fill in either New Operations/Startup or Expansion, not both.)
New Operations / Start Up - Plans Over the Next Ten Years
Expansions - Plans Over the Next 10 Years
Part 1. Are you currently/planning on
Part 1. Are you currently leasing space in Nevada?
leasing space in Nevada?
If No, skip to Part 2. If Yes, continue below:
If No, skip to Part 2. If Yes, continue below:
What year(s)?
What year(s)?
How much space (sq. ft.)?
How much space (sq. ft.)?
Annual lease cost at current space:
Yes
2004-present
35,156
$594,828.00
Annual lease cost of space:
Due to expansion, will you lease additional space?
Do you plan on making building tenant improvements?
If No, skip to Part 3. If Yes, continue below:
If No, skip to Part 2. If Yes * , continue below:
Expanding at the current facility or a new facility?
New
When to make improvements (month, year)?
What year(s)?
2016
Yes
How much expanded space (sq. ft.)?
75,257
$460,281.00
Part 2. Are you currently/planning on
Annual lease cost of expanded space:
buying an owner occupied facility in Nevada?
Do you plan on making building tenant improvements?
If No, skip to Part 3. If Yes * , continue below:
If No, skip to Part 3. If Yes * , continue below:
Purchase date, if buying (month, year):
When to make improvements (month, year)?
Yes
Jul-2016
How much space (sq. ft.)?
Do you plan on making building improvements?
Part 2. Are you currently operating at an
If No, skip to Part 3. If Yes * , continue below:
owner occupied building in Nevada?
When to make improvements (month, year)?
If No, skip to Part 3. If Yes, continue below:
No
How much space (sq. ft.)?
Part 3. Are you currently/planning on
Current assessed value of real property?
building a build-to-suit facility in Nevada?
Due to expansion, will you be making building improvements?
If Yes * , continue below:
When to break ground, if building (month, year)?
Estimated completion date, if building (month, year):
If No, skip to Part 3. If Yes * , continue below:
How much space (sq. ft.)?
Part 3. Do you plan on building or buying a
new facility in Nevada?
When to make improvements (month, year)?
No
If Yes * , continue below:
Purchase date, if buying (month, year):
When to break ground, if building (month, year)?
Estimated completion date, if building (month, year):
How much space (sq. ft.)?
* Please complete Section 7 - Capital Investment for New Operations / Startup.
* Please complete Section 7 - Capital Investment for Expansions below.
BRIEF DESCRIPTION OF CONSTRUCTION PROJECT AND ITS PROJECTED IMPACT ON THE LOCAL ECONOMY (Attach a separate sheet if necessary):
We are planning tenant improvements of approximately $2.2 million. The project will include construction in the manufacturing space including specialty air
handling specific to the industry.
2
Section 7 - Capital Investment (Fill in either New Operations/Startup or Expansion, not both.)
New Operations / Start Up
Expansions
How much capital investment is planned? (Breakout below):
How much capital investment is planned? (Breakout below):
Building Purchase (if buying):
$0
Building Purchase (if buying):
Building Costs (if building / making improvements):
$0
Building Costs (if building / making improvements):
$0
$2,200,000
Land:
$0
Land:
Equipment Cost:
$0
Equipment Cost:
$2,079,000
$0
Total:
$0
Total:
$4,279,000
Is the equipment purchase for replacement
of existing equipment?
Current assessed value of personal property in NV:
No
$325,881
(Must attach the most recent assessment from the County Assessor's Office.)
Section 8 - Employment (Fill in either New Operations/Startup or Expansion, not both.)
New Operations / Start Up
Expansions
How many full-time equivalent (FTE*) employees will be created by the
end of the first fourth quarter of new operations?:
Average hourly wage of these new employees:
How many full-time equivalent (FTE*) employees will be created by the
end of the first fourth quarter of expanded operations?:
25
Average hourly wage of these new employees:
$23.12
How many FTE employees prior to expansion?:
Average hourly wage of these existing employees:
112
$24.94
Total number of employees after expansion:
137
* FTE represents a permanent employee who works an average of 30 hours per week or more, is eligible for health care coverage, and whose position is a "primary job" as
set forth in NAC 360.474.
OTHER COMPENSATION (Check all that apply):
Overtime
PTO / Sick / Vacation
Merit increases
COLA adjustments
Bonus
Other:
Tuition assistance
Retirement Plan / Profit Sharing / 401(k)
BRIEF DESCRIPTION OF ADDITIONAL COMPENSATION PROGRAMS AND ELIGIBILITY REQUIREMENTS (Attach a separate sheet if necessary):
Section 9 - Employee Health Insurance Benefit Program
Is health insurance for employees and an option for dependents offered?:
Yes (copy of benefit plan must be attached)
No
Package includes (check all that apply):
Medical
Vision
Other: Adding Employer paid Short Term
and Long Term disability in 2016
Dental
Qualified after (check one):
Upon employment
Three months after hire date
Health Insurance Costs:
Cost of health insurance for company (annual amount per employee):
Health Plan annual out-of-pocket maximum (individual):
Six months after hire date
Other:
Two months after hire date
Percentage of health insurance coverage by:
$ 7,480.00
$ 4,500.00
[SIGNATURE PAGE FOLLOWS]
3
Company:
Employee:
66%
34%
5(A) Capital Equipment List
Company Name: ProThera, Inc.
County: Washoe County
Section 1 - Capital Equipment List
Directions: Please provide an estimated list of the equipment [columns (a) through (c)] which the company intends to purchase over the two-year
allowable period. For example, if the effective date of new / expanded operations begins April 1, 2015, the two-year period would be until March
31, 2017. Add an additional page if needed. For guidelines on classifying equipment, visit:
tax.nv.gov/LocalGovt/PolicyPub/ArchiveFiles/Personal_Property_Manuals. Attach this form to the Incentives Application.
(a)
Equipment Name/Description
Capsulation Semi-Automat
Capsulation Semi-Automat
Capsulation Full-Automat
Capsulation
1505
Full-Automat 1505
Capsulation Full-Automat
Capsulation
705Full-Automat 705
Capsulation Toolset
Capsulation Toolset
Tabletting Semi-Automatic
Tabletting Press
Semi-Automatic Press
Tabletting Full-Automatic
TablettingPress
Full-Automatic Press
Tabletting Toolset
Tabletting Toolset
Powder
Powder
Mixing/BlendingMixing/Blending
Other
Barcode scanning, furniture items, scoops,
rugs, cleaning and maintenance tools,
industrial size dishwashing equipment.
Lab Equi
Lab Equipment
TOTAL EQUIPMENT COST
( b)
# of Units
(c)
Price per Unit
(d)
Total Cost
4
1
2
1
1
2
1
1
1
$54,000.00
$260,000.00
$135,000.00
$431,030.00
$128,000.00
$21,875.00
$352,625.00
$15,000.00
$361,000.00
$198,000.00
$192,500.00
$200,000.00
$416,540.00
$106,500.00
$30,625.00
$303,538.00
$13,438.00
$278,000.00
1
1
$371,359.00
$40,750.00
$311,354.00
$29,025.00
$2,079,520.00
6
Is any of this equipment* to be acquired under an operating lease?
*Certain lease hold equipment does not qualify for tax abatements
6
Yes
No
5(B) Employment Schedule
Company Name:
ProThera, Inc.
County: Washoe
Section 1 - Full-Time Equivalent (FTE) Employees
Directions: Please provide an estimated list of full time employees [columns (a) through (d)] that will be hired and employed by the
company by the end of the first eighth quarter of new / expanded operations. For example, if the effective date of new / expanded
operations is April 1, 2015, the date would fall in Q2, 2015. The end of the first fourth quarter would be the last day of Q2, 2017 (i.e., June
30, 2017). Attach this form to the Incentives Application.
A qualified employee must be employed at the site of a qualified project, scheduled to work an average minimum of 30 per week, if offered
coverage under a plan of health insurance provided by his or her employer, is eligible for health care coverage, and whose position of a
“primary job” as set forth in NAC 360.474.
(a)
(b)
(c)
(d)
(e)
(f)
Number of Average Hourly Average Weekly Annual Wage per
New Hire Position Title/Description
Total Annual Wages
Positions
Wage
Hours
Position
Encapsulator professional
8
$18.27
40
$38,000.00
$304,000.00
Encapsulation supervisor
1
$20.19
40
$42,000.00
$42,000.00
Tabletting professionals
2
$16.83
40
$35,000.00
$70,000.00
Formulator
1
$24.04
40
$50,000.00
$50,000.00
Maintenance and facility manager
1
$31.25
40
$65,000.00
$65,000.00
VP of operations
1
$60.10
40
$125,000.00
$125,000.00
Maintenance mechanics
2
$18.27
40
$38,000.00
$76,000.00
Miller/Blender
2
$21.63
40
$45,000.00
$90,000.00
Sanitation Technician
2
$16.83
40
$35,000.00
$70,000.00
QA manager
1
$24.04
40
$50,000.00
$50,000.00
Director of regulatory affairs
1
$38.46
40
$80,000.00
$80,000.00
Product data specialist
1
$28.85
40
$60,000.00
$60,000.00
Production planner
1
$28.85
40
$60,000.00
$60,000.00
Buyer
1
$28.85
40
$60,000.00
$60,000.00
TOTAL
25
$23.12
40
$783,000.00
$1,202,000.00
Section 2 - Employment Projections
Directions: Please estimate full-time job growth in Section 2, complete [columns (b) through (c)]. These estimates are used for state
economic impact and net tax revenue analysis that this agency is required to report. The company will not be required to reach these
estimated levels of employment.
(a)
Year
(b)
Number of FTE(s) Projected
3-Year
4-Year
5-Year
4
4
4
(c)
Average Hourly Wage
$23.00
$23.25
$23.50
7
(d)
Payroll
$191,360.00
$193,440.00
$195,520.00
Site Selection Factors
Company Name: ProThera, Inc.
County: Washoe County
Section 1 - Site Selection Ratings
Directions: Please rate the select factors by importance to the company's business (1 = very low; 5 = very high). Attach this form to the Incentives
Application.
Availability of qualified workforce:
Labor costs:
Real estate availability:
Real estate costs:
Utility infrastructure:
Utility costs:
Transportation infrastructure:
Transportation costs:
State and local tax structure:
State and local incentives:
Business permitting & regulatory structure:
Access to higher education resources:
5
5
3
3
3
3
OTHER FACTORS & RATINGS:
5
4
4
5
5
3
3
A BO
A BO
UTUT
USUS
MORE THAN 47 YEARS OF SERVICE
ProThera®, Incorporated specializes in the research, formulation, and manufacture of nutraceutical
products for exclusive distribution by healthcare professionals for clinical application.
We have earned a reputation as an innovative, solution-oriented company whose products are
based on a firm scientific foundation and sound medical research. Flexibility, rapid response,
and personalized attention to the individual needs of customers describes our underlying
service philosophy. Long associated with product innovation, our three brands offer a complete
line of professional-quality nutraceuticals with over 400 products to enhance and support total
health and wellness.
Integrated Formulas
ProThera® products were launched with
the founding of ProThera®, Inc. in 2001.
Its integrated formulation approach
maximizes synergism between nutrients
in a cost-effective fashion. Versatile
multiple vitamin/mineral supplement
formulas form the core nutrient
foundation which coordinate with single
ingredient and multinutrient formulas
to create comprehensive programs
by avoiding nutrient redundancy and
utilizing fewer pills at lower cost.
Foundational multivitamins
• Ultra-pure fish oils
• Coordinated multinutrients
•
Focused GI & Immune Support
Anti-Aging & Total Wellness
ProThera®, Inc. acquired the highly
respected Klaire Labs® brand in 2004.
Klaire Labs® was originally founded by
Claire Farr in 1969 with the specific
goal of providing nutritional support for
individuals with severe food allergies
and environmental sensitivities. Having
developed some of the very first
hypoallergenic supplements, Klaire Labs®
can be used with confidence by even the
most sensitive individuals.
In February 2014, ProThera®, Inc. acquired
Complementary Prescriptions™ adding
effective supplements for anti-aging
programs. Founded in 1979, the strength
of the brand lies in providing a modular
concept of establishing a nutritional
foundation of multinutrients, minerals,
and phytonutrients based on gender, age,
and personal goals. Adding antioxidants,
hormone support, and energizers further
creates effective anti-aging programs.
Broad probiotic selection
• Hypoallergenic, dairy- and gluten-free
• Antibiofilm and digestive enzymes
•
•
Hormone support
• Multinutrients, minerals, phytonutrients
• Energizers
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A BOUT US
FROM OUR COMMUNITY TO YOURS
ProThera®, Inc. is located in Reno, Nevada, nestled on the eastern slope of the Sierra Nevada. Reno
is known for spectacular weather providing almost unlimited recreational activities, including the
largest concentration of ski facilities within a 50-mile radius. The Truckee River runs through the
heart of downtown Reno and just 30 minutes away is beautiful Lake Tahoe, the largest alpine lake
in North America. Reno is home to a university, a Triple-A baseball park, an urban whitewater
kayak park, multiple geothermal companies, and a great number of notable businesses.
With over 110 employees, ProThera®, Inc. is an integral part of our thriving community. Skilled,
driven, and dedicated employees define our organization. Our goal is to provide practitioners with
educational resources, innovative products, and practice management solutions to support the
communities they serve, including:
Autism Spectrum and Special Needs
Increasingly, parents and practitioners are finding that a
biomedical approach may improve outcomes in children with
special needs including those on the autism spectrum. Probiotics,
digestive enzymes, vitamins, minerals, and specialty
supplements are key components as primary interventions or as
adjunctive measures.
Medical Weight Management
Mounting evidence indicates the intestinal microbiota
contributes to the regulation of energy homeostasis, body
weight, and glucose metabolism. New observations raise the
exciting potential that probiotic and prebiotic supplementation
may provide new options for supporting healthy weight
management and energy metabolism by helping balance the
gut microbiota.
Surgical Weight Management
Bariatric surgery can have a tremendous positive impact on
health. However, these surgeries may also result in various
nutritional deficiencies. We provide a comprehensive suite of
products that are formulated to address common nutritional
challenges vital to maintaining health.
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Anti-Aging and Total Wellness
Maintaining optimal health by slowing down the aging process
from the inside out as individuals grow chronologically older
is supported with innovative products such as antioxidants,
hormone support, and advanced skincare formulas.
Destination Health Resorts
Those wishing to live healthier, longer, more joyful lives through
integrative wellness programs often seek the advice of key
opinion leaders and the tranquility of health resorts, which often
build individualized programs utilizing our private labeling and
custom formulation services.
Advancing Integrative Medicine and Future Practitioners
We have an unwavering commitment to help empower future
generations of practitioners for a career in the art and science
of natural medicine through training partnerships with leading
holistic colleges. And, we are glad to have the opportunity to
advance practitioners along their lifelong learning continuum
by sponsoring events which provide high-quality professional
development opportunities that enhance patient care.
M A NUFAC TUR ING OV ERV IE W
MANUFACTURING EXCELLENCE
Manufacturing Overview
ProThera , Incorporated nutraceuticals are produced in licensed
manufacturing facilities that strictly adhere to current Good
Manufacturing Practices (cGMPs). Products provided in tablet,
capsule, and powder form are made in licensed manufacturing
facilities. The facility is also approved by governmental agencies
in the United Kingdom and the European Community (EC) to
manufacture a drug product. Current GMPs and written standard
operating procedures (SOPs) are strictly followed through all stages
of production to produce products that meet or exceed United
States Pharmacopeia (USP) standards.
®
Excipients
ProThera®, Inc. products are free of artificial flavors, preservatives,
and colorings. Naturally derived, inert materials, including
cellulose-based excipients, vegetable-derived magnesium stearate,
L-leucine, and silicon dioxide are used in very small amounts
as tableting and encapsulation aids. Tablets are protected with
an inert, water-soluble cellulose coating that dissolves readily
upon ingestion, thus facilitating disintegration time. Vegetarian
capsules made of plant cellulose are used exclusively for twopiece encapsulated products. The following common allergens
are avoided unless otherwise specified in ingredient listings: dairy,
eggs, tree nuts, peanuts, wheat, yeast, and soy.
ProThera®, Inc. operates an NSF GMP registered
facility. NSF® is an independent, third-party
inspection, testing, and certification company
committed to public health and safety. ProThera®,
Inc. integrates this GMP registration with ISO 9001
to ensure GMP 9000 compliance.
Raw Material Specifications
Active ingredients in ProThera®, Inc. products are selected
based on purity, bioavailability, documented actions, and safety
characteristics. Materials meeting USP standards are used for
those nutrients where this standard exists. Raw materials are
purchased exclusively from reputable vendors who provide detailed
Certificates of Analysis for every lot of material. These certificates
certify that active components, toxic elements, and microbial
content are within specified acceptable parameters. Purity and
potency of all raw materials are verified through independent
testing laboratories by raw material vendors and ProThera®, Inc.
All incoming raw materials undergo quarantine, inspection,
evaluation, and identity testing by infrared spectroscopy. Purity
and potency of all raw materials are verified through independent
testing laboratories. Raw material vendors and third-party labs are
routinely inspected by on-site audits for quality compliance by
ProThera®, Inc. quality assurance personnel.
Quality Control Laboratory Testing
On-site laboratory personnel evaluate physical characteristics of
each finished product including hardness, disintegration, moisture
balance, friability, and pH. Purity and potency of finished product
is independently verified through outside commercial laboratories
using a randomized ingredient and batch testing program.
ProThera®, Inc. tablets and capsules are tested using the official US Pharmacopeia
(USP) testing method to ensure appropriate and reliable disintegration. Tablets
and capsules disintegrate in 45 minutes or less to help maximize nutrient
bioavailability.
Key to General Pill Sizes (Actual size)
Multivitamin Tablets
Chewable Tablets
Multivitamin Capsules
Fatty Acid Softgels
Mini Softgels
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A BO UT US
M A NUFAC TUR ING OV ERV IE W
Klaire Labs® Probiotic Manufacturing
Clinical effectiveness of probiotic organisms is dependent on many
variables. Identification and selection of appropriate, documented
probiotic species as well as maintenance of maximum viability
throughout all stages of handling is central to expression of the full
potential of beneficial microorganisms. Klaire Labs® probiotic
quality assurance commitment consists of an aggressive,
independent testing program that monitors and ensures the identity,
viability, and hypoallergenicity of our finished products.
Selecting the Proper Probiotic Strains
Klaire Labs® uses only the purest and highest-quality probiotic
ingredients available. Probiotic species used in our formulations
have been researched, genetically documented, and representative
microorganisms have been banked in recognized microbial
culture collections.
• Human-compatible species of Lactobacillus, Bifidobacterium,
Saccharomyces, and other beneficial biota
• Colonizing and transient species with documented benefit
Testing All Probiotic Raw Materials
Probiotics are highly sensitive to handling, transport, and storage.
Our rigorous testing program monitors stability throughout all
manufacturing stages. Upon receipt, all probiotic raw materials
undergo independent laboratory analysis for verification of purity
and stated potency prior to use in manufacturing.
Humidity & Temperature Control
Moisture and heat are enemies of probiotic viability. Our probiotic
formulations are manufactured and packaged at a GMP-compliant
facility, where filtered air systems and a humidity- and temperaturecontrolled environment help ensure product stability and purity at
this critical stage of handling.
Verifying Strain Identity
Third-Party Testing of Each Finished Batch
Ribotyping is a highly reproducible, precise diagnostic genetic
fingerprint that identifies and classifies bacteria based upon
differences in ribosomal RNA. This method establishes the
authenticity of probiotic microorganisms by comparing them
to strains documented in the literature to possess a specific
genetic makeup or pattern. Strains used in Klaire Labs® probiotic
formulations have undergone ribotyping to validate the specific
genetic pattern in comparison to established, documented strains.
To ensure that manufacturing and packaging processes do not
adversely affect potency, all KIaire Labs® finished probiotic
products are independently tested prior to release. Probiotic
enumeration and microbial integrity are evaluated on each batch
to ensure quality of the final product.
RiboPrint® Pattern
116-101-7 ATTC 4356 Lactobacillus acidophilus
The genetic fingerprint of Lactobacillus acidophilus in Klaire
Labs ® probiotic formulas identified as L. acidophilus ATCC
4356 matches #116-101-7 in the RiboPrint® Pattern.
Growing Dairy-Free Hypoallergenic Strains
Cow’s milk allergy is one of the most common food allergies in
infants and children. Evidence suggests that probiotics cultured
using dairy products may be associated with an increased risk for
developing sensitivity to cow’s milk. Ensuring the absence of dairy
proteins in probiotic supplements is a difficult task, as almost
all commonly available probiotic materials are grown on dairycontaining media. Klaire Labs® probiotic bacteria are specially
cultured on a proprietary, vegetarian growth media to help ensure
maximum tolerance and absence of dairy proteins.
Certifying Each Batch as Dairy-Free
Each finished batch of Klaire Labs® probiotics is analyzed using
Neogen® Veratox testing, a highly sensitive technique that detects
levels as low as 0.00025% (<2.5 ppm) of milk allergens such as
casein. Other methods commonly employed in the industry have
higher detection levels of 0.1% (1,000 ppm) and may inaccurately
report absence of dairy even though it is present. Dairy-sensitive
individuals can use Klaire Labs® probiotics with confidence.
Maintaining Shelf-Life
Routine inclusion of higher quantities of microorganisms than stated
on our labels coupled with refrigerated storage and temperaturecontrolled shipping ensure that our probiotics, when properly
stored and refrigerated, will retain their stated potency for at least
one year from the date of manufacture. Shelf-life is confirmed by
stability testing.
Brand
Potency Claim
per Capsule
Test Result
Percent of
Label Claim
Milk
Allergen
Klaire Labs®
Ther-Biotic®
Complete
25 billion CFU
47.9 billion CFU
192%
Below
detection
Company A
12 billion CFU 11.4 million CFU
.10%
4 ppm
Company B
15 billion CFU
25 million CFU
.17%
16 ppm
Company C
20 billion CFU
26.3 million
CFU
.13%
Below
detection
(.0114 billion CFU)
(.025 billion CFU)
(.0263 billion CFU)
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Our Values
We aspire to a set of values which are the guiding principles that define
how we conduct our business and what we stand for as a company.
FAMILY ORIENTATION
•
Support staff to achieve a genuine
work-life balance
•
Flexible efficient working environment
•
Commitment to the community
MULTICULTURALISM
•
We believe in a multicultural organization
to best understand the needs of our market
•
A broad range of talents and views
are encouraged
TRUST AND RESPECT
•
Teamwork and inclusivity
•
Personal responsibility & empowerment
•
Integrity in everything we do
•
Equal respect for all (internal & external)
•
Follow through on promises
ENTREPRENEURIALISM
•
Always create & explore opportunities
•
Take on big challenges and see them through
•
Passion for success and to excel
•
Freedom to learn from mistakes
•
Challenge the status quo - a “can-do” attitude
•
Be innovative in our thinking