Do you run biophysical analyses under cGMP standards?
No, and thus we cannot accept samples of licensed final products for analysis. We of course try to conform to principles of good laboratory practice, but meeting cGMP standards for these biophysical techniques is generally not possible. The software for these instruments is not compliant with 21 CFR Part 11 guidelines, and the protocols have not been formally validated.
It is our understanding that characterization data for products under development does not need to meet cGMP standards. Data we have generated has been used by our clients in documents submitted to regulatory agencies, such as CMC sections, comparability protocols, or responses to regulatory queries. However, it is your responsibility, not ours, to ascertain what regulatory guidelines may need to met for your intended use of the data.
Who have you worked for?
We have done work for over 250 different industrial clients in the US, Canada, Europe, Asia, and Australia, including most of the major biotechnology and pharmaceutical companies. We have also done work for a number of universities and several non-profit research organizations and government labs. Among the industrial customers we can mention are Allergan, Aventis, Baxter, Bayer, Biogen-IDEC, Chiron, Chugai, Gryphon Therapeutics, Immunex, MedImmune, Schering-Plough, Seattle Genetics, Serono International, and Zymogenetics.
Do you charge per sample, per analysis, per job, per hour, or...?
We can use any of these methods. Our fee structure depends on the nature and type of work, as well as on your preferences. CD studies are normally charged on a per sample basis; other methods are also generally per sample (usually per set of 3 samples for AUC), but may also involve setup fees. We can quote a fixed price for a set of experiments, or a rate per sample for characterization studies, or we can simply agree on a rate per hour/day/week. Purification projects are usually best handled based on time spent or price per purification step employed.
The majority of the characterization projects we do cost less than $5,000 total.
For contract characterization services what sort of reports and data do you provide?
Usually we provide a summary report that outlines the methods used, gives graphs and/or tables of the results, and summarizes the conclusions, in the form of a locked Adobe Acrobat (.pdf) file. If you have specific reporting or formatting requirements those should be communicated before we agree on a price.
We do not normally supply the raw data (computer files). Indeed the FDA has asked us not to do so and most clients would not have software that could read the files anyway. If you absolutely must have the raw data you would need to discuss this with us in advance.
What is your normal turn-around for analytical work?
The turn-around will likely vary depending on the techniques involved. Typically for CD studies we are able to begin work on a new project within 1-2 weeks. Recently for AUC or light scattering studies turn-around to a completed report has been 2-4 weeks. We work strictly on a first-in, first-out system, based on when the samples actually reach us. We do not accept "rush" jobs at higher fees because this can effectively lock out smaller companies.
Will you provide services to universities or non-profit institutions at reduced fees?
We welcome collaborative research projects with academic investigators, and will generally do such work at a considerably reduced fee. In some cases we seek only to recover our costs for materials and consumables. Obviously the time we have available for such projects is very limited. Our full-fee paying clients get top priority, and reduced-fee work generally must wait for slack periods (which are very few).
Can you express my protein as well as purify it?
Sorry no, we are not equipped to do the expression ourselves.
Can you formulate my protein?
We are not equipped or staffed to carry out a complete formulation or formal stability studies. Such services can, however, be obtained through our collaboration with Integrity Biosolution, whom we highly recommend. Our biophysical characterization techniques are a valuable tool for pre-formulation studies, as well as for detailed studies of aged and stressed samples. Dr. Arakawa's unique expertise on the effects of solvent conditions and excipients on protein stability can be used to help resolve stability issues for difficult proteins.
Do you accept payments by credit card?
Sorry, no, we can't do this. We can however accept payments via PayPal.
How are billing and payments usually handled?
This really depends mostly on what procedures are required within the client's organization. Most clients issue a purchase order, some require a contract or service agreement, and for some we simply send an invoice indicating what work was done and for whom.
How do you maintain confidentiality?
For our industrial clients we normally execute a Non-Disclosure Agreement (NDA) or a Materials Transfer Agreement (MTA), either at some point during pre-contract discussions or as part of a contract or service agreement.
At the conclusion of the work any left-over samples are usually destroyed, but upon request they will be returned (at the client's expense).
Does your company have any financial or other ties to Amgen that might compromise confidentiality?
No, we have no ties to or formal relationships with Amgen since leaving our employment there over 15 years ago. Our sole business connection to Amgen is that Amgen has been an occasional client, representing less than 1% of our total business.
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