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Exploratory Stage Immunogenicity Studies  
 
Clone-E has extensive experience in conducting studies designed to assess immune responses to a substance. Multiple species,routes of administration, substance formulations,and study designs are possible. Assays to measure resultant immune responses are available.
Species:
Rabbits
Mice
Rats
Guinea pigs
Ferrets
Sheep
Goats
Routes:
Subcutaneous
Intramuscular
Intravenous
Intradermal
Intraperitoneal
Intranasal
Intracranial
Oral
Ocular
Dermal (topical)
Vaginal
Substance formulations are typically supplied by the customer, although Clone-E will mix your substance with any commercially-available adjuvant upon your request. Study designs can be custom or standard. See polyclonal antibody production area for standard designs.
Assays to measure resulting immune responses can be performed following standard methods, your transferred method, or a newly-developed method as needed.
Please contact us to discuss your particular needs. Let us help you.
Polyclonal Antibody Production
Clone-E offers two protocols for maximizing antibody production in terms of levels of antibody and volume of serum. These protocols represent a basic approach that can be extended and enhanced using the available options listed below or your custom study design.
Standard Protocol
The standard protocol outlined below can be used with almost any plasmid DNA coding for usually of unknown or weak immunogenicity.

Day

Procedure

0

Pre-immunization test bleed

0

Primary immunization

21

Immunogen boost

42

Immunogen boost

52

Standard bleed

(ELISA or Western Blot available)

63

Immunogen boost

73

Standard bleed

(ELISA or Western Blot available)

Fast Protocol
The fast protocol can be used with almost any plasmid DNA coding for usually of known or strong immunogenicity.

Day

Procedure

0

Pre-immunization test bleed

0

Primary immunization

21

Immunogen boost

31

Standard bleed

(ELISA or Western available)

42

Immunogen boost

52

Standard bleed

(ELISA or Western available)

Protocol Options
The following options are available for tailoring the protocols to produce the antibodies you need: screening animals (test bleed) for existing antibodies prior to placement on a study, serum filtration through 0.45 micron filter, Western blots or ELISA as screening/assessment tools, serum antibody purification, or your customized study parameters. In addition to these options, any protocol may be extended to obtain a larger volume of serum or to possibly increase antibody titers.
Standard Monthly Extension Protocol

Extention Day

Procedure

1

Immunogen boost

12

Standard bleed

27

Standard bleed (or exsanguination)

Antibody Production in Many Animal Species
Antibody production can be conducted in a variety of animals. Although the rabbit is, in most instances, the ideal animal for polyclonal antibody development, mice, rats, guinea pigs, ferrets, sheep, and goats are also available. The table below indicates expected serum volume per species per protocol.
Approximate serum volumes (ml) per bleed for multiple species

 

Rabbit

Rat

Guinea pig & Ferret

Mouse

Sheep & Goat

Test bleed

5

0.25

0.5

0.2

15

Fast protocol

Day 0 pre-bleed

5

0.25

0.5

0.2

50

Day 31 standard bleed

15

0.5

1

0.2

400

Day 52 standard bleed

15

0.5

1

0.2

400

Standard protocol

Day 0 pre-bleed

5

0.25

0.5

0.2

50

Day 52 standard bleed

15

0.5

1

0.2

400

Day 73 standard bleed

15

0.5

1

0.2

400

Protocol extension

Day 12 standard bleed

15

0.5

1

0.2

400

Day 27 standard bleed

15

0.5

1

0.2

400

or

Day 27 exsanguination

60

5

6

0.5

1500*

Exsanguination

60

5

6

0.5

1500*

Plasmapheresis

-

-

-

-

1500

Clone E Therapeutics Inc.also offers a comprehensive catalog of antibody products for many research areas like Cancer, Neuroscience, Apoptosis, Infectious Diseases, Biowarfare Agents, DNA, Hormones, Enzymes, and many more by using enhanced LARGE SCALE PLASMID MANUFACTURING proprietary technology.

?Clone E is uniquely positioned to produce both high copy and low copy number plasmids. Our customers benefit from the experience and dedication of the scientific staff as we aim to provide you with high quality plasmids .We archive large quantities for free and will ship in split batches delivering it to you when you need it. RELIABLY OUTSOURCE YOUR VECTOR PRODUCTION TO Clone E NOW AND SAVE TIME AND MONEY!

?If Gene therapy research, Genetic immunization, In vitro and in vivo tansfection studies including pre clinical trials are your hot areas of research then prefering our Large scale plasmid manufacturing service is cost effective and efficient way to achieve your need of large quantities of plasmid DNA.
We manufacture plasmid DNA at standard research and pre-clinical grades which is most suitable and ready to use product with desired quality.
Standard Research Grade: Low levels of residual endotoxin levels less than 0.1 EU/μg plasmid DNA (FDA specifications).
Pre-Clinical Grade: We guarantee our purification with the certificate of Undetectable residual proteins and Very low residual solvents and free of bioburden
Unique and efficient Quality Control
Our robust processing and wide range of quality control testing allow us to certify top quality plasmid DNA. certificate of analysis will be provided for each batch of plasmids which meets following criterias.

Characteristics

Specifications

Test

Visual Appearance in water

Clear, colorless

Visual inspection

Plasmid identity

Restriction pattern

Agarose gel electrophoresis and sequencing

Plasmid DNA homogeneity

>95% supercoiled form

Agarose gel electrophoresis

Purity

1.7 - 2.0 A260/A280

Spectrophotometer measurements

pDNA concentration

absorption at 260nm

provided or as specified by client

Presence of host chromosomal DNA

<5%

Agarose gel electrophoresis

Presence of RNA and ssDNA

Undetectable

Agarose gel electrophoresis

Level of endotoxin

<0.1 EU/μg plasmid DNA

Biowitthaker LAL test

Presence of protein
(pre-clinical grade only)

<1%

Micro BCA assay

Sterility
(pre-clinical grade only)

Absence of microorganisms

Bioburden assay

Sequence analysis will be provided upon request.

Our scalable and robust purification process with confident of obtaining the best possible plasmid DNA quality and yields can support you from research through production.

RAPID PREP QUALITY ASSURANCE

• Optimized fermentation process ensures higher quantity and higher quality plasmid

• Free of cesium chloride/ethidium bromide and organic solvents

• Top quality plasmid with
Low levels of residual endotoxin levels <2 EU per mg

  • Less than 1% host cell chromosome
  • More than 95% covalently closed circular plasmid.
  • Negligible levels of RNA.
  • Undetectable residual proteins
  • Very low residual solvents

• Wide range of quality control testing

• Transformation of DNA included

• Formulated to your specifications

• Certificate of Analysis included

• Additional testing available upon request

For years, Clone-E has been well known for high-quality, fast turn-around plasmid DNA production services. These include production of individual constructs for researchers as well as large scale manufacturing for biotech suppliers and pharmaceutical companies with complete dedication to customer satisfaction and long term ultimate success. We intend to discover novel therapeutic antibodies and to build a diversified product portfolio through our R&D and partnerships

GRADE SUITABILITY AMOUNTS

RESEARCH GRADE ANIMAL EFFICACY STUDIES 500 MG TO KILO-GRAM QUANTITIES

GLP (WELL-CHARACTERIZED)GRADE ANIMAL SAFETY STUDIES 500 MG TO KILO-GRAM QUANTITIES

ADVANTAGES
Outsourcing vector production to Clone E now offers an attractive alternative solution to either in-house production or piecemeal contract production. It may be possible to outsource your company’s entire vector production schedule for only a small percentage of your current cost. Utilize quickly our program to improve reliability, speed ,cost control and most importantly your need and research..

RELIABILITY
Plasmid DNA is traditionally produced by either cesium chloride/ethidium bromide gradient centrifugation or by column purification.

Clone E column pruification is used extensively, avoiding mutations caused by ethidium bromide cross-linking and intercalation, and it provides a convenient way to eliminate endotoxins (lipopolysaccharides) leading to improve transfection efficiency, reduce toxicity and greater user satisfaction.

Each plasmid DNA is analyzed according to the customers specifications to ensure integrity. The plasmid stock is picked from isolated colonies to avoid heterogeneity resulting from extended culture or the use of glycerol stocks.

COST CONTROL
There is presently no way to standardize yields of plasmid DNA obtained by fermentation, leading to the common practice of pricing based on culture volume (cost per liter). This variability results from the diversity of vectors and the copy number, which can vary from a single copy per cell to over 200 copies. Most plasmids are now high-copy, but the variability is a significant factor in production.

Clone E solves the pricing problem by providing a single fixed price for a specified gene. Considerable savings are possible, based upon the amount ordered. Quantities from 500 mg or more are possible, with the availability of high-quality research-grade plasmid DNA, as well as “GLP-grade,” (well-characterized DNA) for animal studies. In addition, the GLP process is both scalable and transferable, paving the way for outsourcing commercial GMP production at a later time. In that way, your future needs can be fulfilled through a variety of choices.

THE RESULTS
Using Clone E virtual supply method, companies enjoy shortened time to delivery, decreased inventories, freed-up space and manpower for more important projects, and still provide higher quality products that are always fresh-and at a lower cost.

SAMPLE CERTIFICATE OF ANALYSIS

"Direct way from gene To Antibody": Genetic Immunization(GI)

FASTER-CHEAPER-EASIER

Antibodies against native proteins through genetic immunization- A most reliable and promising approach.

DNA Immunization for Polyclonal Antibody Production

One of the most important tools in research, diagnostics and protein based drug development are antibodies that allow the identification and the analysis of polypeptide functions and the underlying regulatory mechanisms.

However, the production of antibodies is frequently limited by time consuming, and thus expensive immunization protocols depending on purified protein or by disadvantageous protein properties such as instability, toxicity, low antigenicity or immune tolerance.

Genetic immunization offers enormous advantages over the traditional protein-based immunization method. DNA is faster, cheaper and easier to produce (Our large scale endotoxin free plasmid manufacturing proprietary method offers 1 gram plasmid per liter of culture) and can be produced by the same standard technique that is readily amenable to automation. Clone E offers a fast and reliable plasmid DNA based alternative for functional antibody production in goat, rabbit, mouse, rat and chicken. We assure our custom made antibodies generated by genetic immunization are usually of superior quality with regard to specificity, affinity and recognizing the native protein.

Our Antibody services

  • Polyclonal antisera in rabbit, mice or rats in 6 – 12 weeks as per customer need.
  • Our supply includes pre immune sera and desired poly clonal antisera from immunized animals.
  • Monoclonal antibody generation in mice or rat in 4-9 months and our supply includes positive hybridomas and supernatants for their convenience.
  • Immunization with customer expression vectors as well as our proprietary vectors.
 
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Contact us

2, East 3rd st, N.E.P.Z., Kaohsiung, Taiwan, 811
TEL:+886-7-366-0198
FAX:+886-7-379-1196
E-mail:service@clone-e.com

 
 
Clone-e Therapeutics Inc.

2, East 3rd st, N.E.P.Z., Kaohsiung, Taiwan, 811
TEL:+886-7-366-0198  FAX:+886-7-379-1196
Copyright ©2008 Clone E Therapeutics Inc. All rights reserved.
 

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