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Quick List | |
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Service Terms Confidentiality Delivery Request to the Customers Why SinoBio How to order Frequently Asked Questions | |
To
date, lots of PEGylated protein drugs are marketed or in clinical trials. PEGylation
technology is believed to be the most promised way to optimize drug
pharmacokinetics and decrease immunogenicity of protein drugs include proteins, peptides,
antibody fragments. Key tricks for PEG modification include the following steps:
Screen of PEGs and PEGylation protocol must coupled with separation and function assay to evaluate which really a better choice. Trace of non modified proteins which usually reserve higher biological activities will interfere the judgment. On the other hand, Higher modification ratio doesn't means higher recovery ratio or better productivities. SinoBio Biotech's scientists have successfully PEGylated several PEGylated protein drugs for our customers.
Terms and Timeline
SinoBio Biotech's PEGylation services can provide to customers:
PEGylation could be evaluated by pharmacokinetics, maintain of biological activities, immunogenicity, modification efficiency, cost and so on.
Pilot/Large Scale PEGylated protein manufacture
SinoBio Biotech can scale up PEGylation after PEG Screen.
production could be scale from milligrams to gram. Contract PEGylation for preclinical
trail and clinical trail may provided under GMP condition.
Pilot/Large Scale PEGylation Process Development
Process development services can provide industrial scale PEGylation
process coupled with separation of
drug grade modified proteins. The established process and IP can be transfer to the customer.
Confidentiality
Your
confidential candidate to us by mail will be covered. We will sign non-disclosure
or confidentiality agreements when necessary.
A general
template for MTA and CFA are available and you may change the terms according to
your requirements and discuss it with SinoBio.
Delivery
Materials
delivered to customers include the following:
1. PEGylated
Proteins.
2. Quality analysis results.
3.
Process in details for process development services.
4. Original development records and interim data at GLP
standard for process development services.
4. Manufacture reports, including the
major process, interim results, quality control.
Delivery time:
The typical delivery time for PEG
Screen is 10 working days after we get the enough materials for the experiments.
Time for process development in pilot scale will need 3-6 months and may varied
depending on the complexity of the project.
Time for shipment
is about 4 business days. This may vary depending on where the customer located
and accidentally, delayed by custom check.
The final
products will be shipped via fedex. DHL is optional according to the customer's
requirements.
Request to the Customers
1. Customers can provided us purified proteins or SinoBio Biotech can
manufacture the target protein for you.
2. Provide us the
requirements of the final products essentially the purity and amounts, other
quality control requirements are optional with additional charge such as HPLC,
AA Sequencing, MS, MS/MS, biological activity, endotoxin control etc. For
details please read protein analysis.
3. The customers may provide activated PEGs or SinoBio Biotech acquire proper
PEGs for you.
Correlative Service
Why SinoBio
Professional: SinoBio Biotech focus on recombinant protein manufacture only, and the focus makes us more professional. All of the group leaders are come from big biopharmaceuticals with more than 10 years experience on protein production. The company are well equipped with Bioengenering fermentor, AKATA, HPLC and we can provide cGMP standard for your production. The fermentation scale is from liters to 500 liters. Final production is scale from milligram to tens of gram.
Expertise: SinoBio's protein experts have more than 400 different protein purification experience, involved in NINE biologics development, most of them are in market and some of them in clinical trails. They also developed about 40 qualified cytokines and tens of biological enzymes. SinoBio Biotech have helped our customers to developed tens of PEGylated proteins with several of them are in pre-clinical test now.
Quality: Diverse quality control method available for your choice such as amino acid sequencing, MS, MS/MS, LAL test, HPLC in addition to conventional SDS-PAGE analysis.
Speed: Fast turnaround time (~10 days for a basic order)
Price: Competitive prices as low as 800$
Confidentiality: Strictly confidential customer's data. SinoBio will sign non-disclosure or confidentiality agreements when needed.
How to
order
Please follow these instructions closely to speed up
your ordering process.
1. SinoBio Biotech adopt a non-disclosure policy to all
of our customers. To protect your proprietary information please mail, email
(info@sinobio.net) or fax (+8621-5079-8029) your confidentiality agreement to us
for sign. If intended, this should be done before any information is released to
us. If you don't have your own NDA/confidentiality agreement, you can find ours
at here. Feel free to modify it to suit your specific needs.
2. Call us (+8621-5079-8029) or email us info@sinobio.net.
The information you could provided to us will help us understand your
requirements and how to accomplish your desired results.
Frequently Asked Questions: PEGylation Services
1) How much proteins is needed for a basic PEG Screen services?
2) What requirements of proteins for modification?
3) Is SinoBio experienced in PEGylation?
4) How many PEGylated protein drugs are approved by FDA?
1)>How much
proteins is needed for a basic PEG Screen services
Generally, we need 1 milligram of pure protein
for modification with activated PEGs. This may varied depending on the PEGs the
customers want to screened. 50ug of target proteins for one reaction will be
sufficient but generally we need repeat to get better and stable modification
ratio.
2)
What requirements of proteins for modification?
The target protein are required with high purities and
concentrated. Generally, the purity with SDS-PAGE should be high than 85% and
the concentration should be up to 1mg/ml. SinoBio Biotech can help to change the
buffer into proper reaction buffer. The best choice is discuss with our experts
before you provide the proteins to us. Changing buffer can always lose some
protein and make the protein diluted.
3)
Is SinoBio experienced in PEGylation?
Yes. SinoBio Biotech have helped our customers to developed tens of
PEGylated proteins and several of them are in pre-clinical test now.
4) How many PEGylated protein drugs are approved
by FDA?
To Date, at least ten PEGylated protein drugs are
approved by FDA. And tens of PEGylated proteins are in clinical trails now.
Please refer to the following table from Nektar for approved PEGylated protein drugs:
| Indication | Product | Company | Status |
|---|---|---|---|
| Neutropenia | Neulasta® (pegfilgrastim) |
Amgen | FDA Approved |
| Hepatitis C | PEGASYS® (peginterferon alfa-2a) |
Roche | FDA Approved |
| Hepatitis C | PEG-INTRON® (peginterferon alfa-2b) |
Schering-Plough | FDA Approved |
| Macular Degeneration | Macugen® (pegaptanib sodium) |
(OSI)-Eyetech | FDA Approved Filed in EU |
| Renal Anemia | MirceraŁ¦#8482; (continuous erythropoiesis receptor activator) |
Roche | Approved in EU Filed in U.S. |
| Crohn's Disease | Cimzia (peg-anti-TNF alpha antibody fragment) |
UCB Pharma | Approved in U.S. Approved/Launched In Switzerland |
| Rheumatoid Arthritis | Cimzia (peg-anti-TNF alpha antibody fragment) |
UCB Pharma | Filed in U.S. |
| Acromegaly | Somavert® (pegvisomant) |
Pfizer | FDA Approved |
| Cardiac Imaging | DEFINITY® Vial (perflutren lipid microsphere injectable suspension) |
Bristol-Myers Squibb | FDA Approved |
| Cranial Dural Sealant | DuraSeal® Dural Sealant... |
Confluent Surgical | FDA Approved |
