POINT OF CARE TESTING - FROM CONCEPT TO COMMERCIALISATION LATERAL FLOW DEVELOPMENT AND MANUFACTURING SERVICES - Medica
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POINT OF CARE TESTING FROM CONCEPT TO COMMERCIALISATION LATERAL FLOW DEVELOPMENT AND MANUFACTURING SERVICES
POINT OF CARE TESTING 03
Contents BBI’s mission and values
03 BBI MISSION AND VALUES 10 BENEFITS OF OUTSOURCING Mission Statement
03 I Mission statement 11 I Control capital costs
03 I Our company values 11 I Increase efficiency
04 BBI FOOTPRINT 11 I Reduced labour costs We deliver exceptional products and technologies that people rely on to enjoy
06 I History 11 I Start new projects quickly a better quality of life. Through innovation, partnership, effective delivery
07 I Why BBI 11 I Access to IP or technology
and the collaboration of our people, we constantly strive to help set industry
08 CONCEPT TO CREATION 11 I Focus on your core business
standards, engender trust and build our reputation for excellence.
08 I Sourcing reagents 11 I Level the playing field
08 I Development 11 I Reduce risk
08 I Let our know-how drive your success 12 READER TECHNOLOGY
09 I Manufacture 13 I Mobile Reader Technology
09 I Smartphone Reader Technology 13 I Six Simple Steps Our company values
14 APPLICATION SECTORS These are the practical things BBI believes in. They directly inform the decisions we make and the actions we
15 PREFERRED PARTNERS take as a business.
15 I Axxin
15 I CHIARA
PRECISION
The way we do things is accurate, careful and efficient.
From the way we develop our products, to the way we
interact with clients, customers and partners – we work
to get it right first time.
PARTNERSHIP
We work as a closely-knit team and value our relationships
with other experts and organisations. This gives us the
knowledge and resource to get the right results.
EMPOWERMENT
Our work results in powerful, advanced technologies.
We develop these into practical effective commercial
products and applications – empowering people to live
a better life.
POTENTIAL
We believe in the potential of innovation and our people.
Our business is built on bringing out the best in people –
nurturing talent and fulfilling all our ambitions.
04 POINT OF CARE TESTING POINT OF CARE TESTING 05
5
4
1
7
2 3
BBI Footprint
The core mission of BBI Solutions is to deliver
exceptional service and technologies to improve
the quality of life for all people. With that core value
in mind, we have continually expanded our portfolio
of OEM (Original Equipment Manufacturer) services
and brought first to market innovations such as our 6
mobile diagnostic platform Novarum™.
1. SCOTLAND 2. WALES 3. ENGLAND 4. USA 5. GERMANY 6. SOUTH AFRICA 7. CHINA
BBI Edinburgh BBI Crumlin BBI Sittingbourne BBI Porton Down BBI Portland BBI Freiburg BBI Cape Town BBI Shanghai
• Novarum™ • Enzymes • Human Proteins • Antibodies • Antibodies • Antibodies • Enzymes • WFOE
act •
•
•
Gold Nanoparticles
Gold Conjugation
Lateral Flow Development
• Serum & Plasma
• Cell Culture Reagents
• Antibody Development • Antigens
& Manufacturing Services
06 POINT OF CARE TESTING POINT OF CARE TESTING 07
>750k
The BBI Group ...and had a BBI achieved ...and
1986 was established turnover of less 2000 an MBO 2004 an IPO
in 1986 with than £1 million. in 2000... in 2004.
only 10 staff...
INFECTIOUS
>£1m
DISEASE ASSAYS
DELIVERED EVERY YEAR
MBO IPO
LATERAL FLOW
2013 We rebranded to bring our 2008 2006
Growth continues
through product
and service,
FOCUS
complete offering together acquisitions and
new entities.
SOLD
UNIQUE
as BBI Solutions.
In 2008, the BBI Group
was sold to Alere for END-TO-END Why?
£85m. Alere are
a global POC leader.
£85m
OFFERING
EXPERTS IN THE FIELD OF
2015
In 2015 BBI Group
achieves a turnover 2016
BBI Solutions acquired
Novarum DX Ltd.
IN-VITRO
of £46m. DIAGNOSTICS
ED
BBI Solutions acquired QUALITY
Maine Biotechnology
TE
In 2015 the BBI Group
became an independent 2017 Services adding GUARA
N
250 PARTNERSHIP
company following the antibody development
£46m
acquisition by Exponent to its capabilities.
Private Equity. TO BRING YOUR ASSAY
PROJECTS TO DATE FROM IDEA TO CREATION
April, BBI Group joins the Invested £14m in new
UK Rapid Test Consortium BBI Group Global Headquarters.
to rapidly develop and 2020 2018
rollout coronavirus tests.
June, BBI Group acquires
DIARECT AG, establishing
1986 2020
25+ YEARS
BBI as a leading provider
of antigens in the autoimmune
and tick-borne IVD markets.
EXPERIENCE
08 POINT OF CARE TESTING POINT OF CARE TESTING 09
Concept to creation Smartphone reader technology
Novarum™
+ Mobile app development tailored to your assay
Development + Quick and accurate results, delivered within
regulatory frameworks
Custom reagent development + Enables a customised workflow in the cloud
+ Monoclonal and polyclonal + Simplify your multiplex test product range
antibody development by having one app for all and selecting the
+ Antigen development test features required for your application
+ Enzyme development + On-screen signature pad to capture end user
+ Custom conjugation consent
Development & optimisation
+ Lateral flow assay development
Sourcing reagents Manufacture
Reagents Manufacture & validation
+ Antigens + Lateral flow test manufacture
+ Antibodies + cGMP production of in vitro
+ Enzymes antibodies
+ Serum and Plasma + Antigen production
+ Cell culture reagents + Enzyme production
Nanoparticle labels
+ Gold nanoparticles
+ Gold conjugates
Let our know-how drive your success
WE HAVE EXPERTISE IN:
A dedicated cross-functional team of scientists works exclusively on all phases for your project from
+ Multiple detection labels
feasibility, optimisation and characterisation, to verification and validation. At the end of the development
+ Challenging sample matrices
cycle, we will hand over the design history file so that you fully ‘own’ your test.
+ Developing high sensitivity and specificity assays
+ Multiplex assays
BBI Solutions offer support with the generation of formal pre-clinical verification following CLSI guidelines,
in addition to real time and accelerated stability studies, as well as Quality and regulatory support through + Integration of reader solutions with the test
our partners.
10 POINT OF CARE TESTING POINT OF CARE TESTING 11
Benefits of outsourcing
The decision to outsource the development or manufacture of Control capital costs
Cost-cutting may not be the only reason, but it’s
a lateral flow assay versus producing it in-house is faced by certainly a major factor. Outsourcing manufacturing
converts fixed costs into variable costs, releasing
businesses everyday. capital for investment within your business, and
allowing you to avoid large expenditures in the
Making the right choice can be key to the success of any business and is driven by many factors (presented in early stages of your business. Outsourcing can
Figure 1). Read our guide to discover the benefits and risks associated with outsourcing, along with a five-step also make your firm more attractive to investors,
approach to selecting the right partner. since you’re able to inject more capital directly
into revenue-producing activities.
Figure 1. Reasons given for outsourcing
For example, to set-up a small lab capable of
Cost Cutting Enables Focus Solves development and manufacture of a small volume
+ Equipment + Lab space - conjugation,
Tool on Core Business Capacity Issues of a basic lateral flow test you would use capital wet reagent prep/striping
+ Ovens
expenditure to invest in the example items listed and dry assembly space
on the right. + Cold rooms or fridges as well as storage for
+ Lamination jugs in-process and finished
goods
Depending on the scale, this could easily run into + Hand pouch sealer
+ General lab equipment
an investment of more than £1 million. In addition,
59% 57% 47% there is the cost of recruitment and training of staff
+ Nitrocellulose and
conjugate pad-striping/
such as stirrers,
spectrophotometers,
spraying lines
as well as an increase in other overheads such as glassware dishwasher
quality, logistics and utilites.
Increase efficiency Access to IP or technology
Companies that do everything themselves have Working with an outsourced partner may give you
Enhances Critical to Access to much higher research development, marketing, and access to technology not currently available in your
Service Quality Business Needs Intellectual Capital distribution expenses, all of which must be passed market and could provide a unique position for your
on to customers. An outside provider’s cost structure product in the market.
and economy of scale can give your firm an important
competitive advantage. Focus on your core business
Every business has limited resources, and every
31% 28% 28% For example, an outside provider may already have the manager has limited time and attention. Outsourcing
Cost Cutting Enables Focus Solves Enhances
Tool on Core Business Capacity Issues Service Quality capacity and equipment to deliver your product at a can help your business to shift its focus from peripheral
scale and price that internally is not achievable. activities towards work that serves the customer,
and it can help managers set clear priorities.
Reduced labour costs
31% Hiring and training staff for short-term or peripheral Level the playing field
59% 57% 47%
projects can be very expensive, and temporary Most small firms simply can’t afford to match the
employees don’t always live up to your expectations. in-house support services that larger companies
Manages Business Drives Broader Outsourcing lets you focus your human resources maintain. Outsourcing can help small firms act ‘big’ by
Environment Transformational Change where you need them most. giving them access to the same economies of scale,
efficiency, and expertise that large companies enjoy.
Critical to Access to Manages Business Drives Broader
Business Needs Intellectual Capital Environment Transformational Change Start new projects quickly
17% 17% A good outsourcing firm has the resources to start Reduce risk
a project right away. Handling the same project Every business investment carries a certain amount
17% 17% in-house might involve taking weeks or months to hire of risk. Markets, competition, government regulations,
28% 28% financial conditions, and technologies all change very
the right people, train them, and provide the support
they need. Also, if a project requires major capital quickly. Outsourcing providers assume and manage
investments (such as investment in equipment), this risk for you, and they generally are much better at
the start-up process can be even more difficult. deciding how to avoid risk in their areas of expertise.
Source: Deloitte’s 2016 Global Outsourcing Survey
Source: Deloitte’s 2016 Global Outsourcing SurveyPOINT OF CARE TESTING 13
READER Mobile Reader Technology
Our Novarum™ technology transforms a smartphone into a diagnostic test reader, empowering users to read
TECHNOLOGY
and share the results of rapid tests from the point of care. Our pioneering technology can be used by anyone,
anywhere, with minimal training: connecting patients and doctors, field workers, lab researchers and primary care
clinicians to specialist practices as part of a mobile eco-system. Novarum holds patents in Europe, the US, China,
Japan and Russia and we are also ISO 13485:2016 certified for Medical Device Quality Management Systems.
Six simple steps
to get started 1. Customise your App
Work with our highly trained team
to develop an application which is
6. Connect and transfer specific to your needs and test.
Send the results to the database 1 2. Download the App
of your choice using email, WiFi,
End users can download
SMS, web, 4G, Bluetooth or USB. a customised Novarum™
Results outside the norm can be software app that gives the
ac
flagged for immediate action. best results with your tests.
4G
6 2
5 3
5. Scan the results 3. Run the test
Novarum’s patented image Perform the test.
capture software shows an
immediate pass/fail result.
4
4. Scan the code
Scanning codes with a smartphone camera
identifies the type of test to be performed,
and the lot and batch numbers.14 POINT OF CARE TESTING POINT OF CARE TESTING 15
Application Sectors Preferred Partners
Human Clinical Axxin
• Infectious disease The Axxin AX-2X-S is a highly flexible, and easy to use rapid testing instrument
• Cardiac platform designed to provide qualitative and quantitative results for visual
• Reproductive Health
colorimetric and fluorescent immunoassays in a single instrument. The system
• Auto-immune/Inflammatory
can be configured to work with a number of labels including europium-based
• Gastroenteric
assays as well as all visual coloured labels.
• Toxicology
CHIARA
Veterinary Our partner CHIARA is dedicated to guiding medical device companies,
regardless of size, through the ever changing and complex global regulatory
• Companion animal testing medical device environment.
• Large animal testing
CHIARA offers a flexible consultancy support service which is tailored to suit
the client providing a clear plan and a hands-on approach to implementation.
Food Safety
• Food spoilage testing
• Allergen contamination testing
• Mycotoxin testing
• Antibiotic residue testing
Industrial Testing
• Water testing
• Contamination testingDiscover how we can help.
Get in touch.
info@bbisolutions.com Part of the
Int: +44 (0) 1495 363 000
USA: +1-207-797-5454
SEPT 20/V1
China: +86 021 61042216
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