candidate molecules

Squillante Emilio (squillae@stjohns.edu)
Wed, 3 Feb 1999 19:17:05 -0500

Could you help me? I am a new professor trying to establish myself in the
biotechnology area. We have developed a process and we would like to
determine whether this process is applicable to pharmaceutical processing
of biological compounds. Our question is, "Does the process affect the
stability of peptide, oligonucleotide or monoclonal antibody-type drug
molecules?" To illustrate, our process might be used to attach something
like insulin to a polylactide-based polymeric bead for use as a carrier for
pulmonary delivery. The analytical method of assessing retention of
biologic activity post-processing is a critical issue and I cannot
overstress its importance: we must not commit our seed money upon a
molecule/assay methodology that might become an experimental cul de sac.
We are not interested in any molecule per se, but rather proof of
principle, so the problem reduces to one of selecting a molecule that is
representative of its class. What we need are candidates that can be
assayed with instruments we possess (or are within our means to purchase),
are relatively inexpensive to acquire, and are representative of their
class (molecules like immunoglobulin G, pancrease/lipase, catalase,
oxytocin, etc.?) I regard your perspective on ease of assay, availability,
lability, and economic issues as invaluable toward selecting suitable
candidate(s).

The question posed to you is generically vague: there is no precedent for
this type of processing in the literature. Furthermore, the selection must
reflect the capabilities of our laboratories: an HPLC, DSC, and
electrophoresis equipment plus my experience with SEC and ELISA. Our
limited analytical capabilities are offset by good working relationships
with academic institutions and pharmaceutical companies in the New York
area. This is an important point: if we chose the molecule wisely and were
to process and store samples for periodic analysis at a remote facility,
could we necessarily extend the range of compounds that could be
considered? Basically, I need a list of equipment to do this type of work
and, with that list in hand, identify what equipment is essential to own
versus that which requires only periodic access. Do you have any advice or
experience you'd care to relate with regard to instrumentation?

Ultimately, we hope to acquire the necessary equipment to establish an
independent research focus. Partial funding ($30,000) for these initial
activities are available through August of 1999. Since a more compelling
application for financial aid can be made if pilot data or pretest
conclusions could be presented to the funding agencies, we solicit your
opinion at this crucial juncture on how best to spend this money. May I
call you at a time that is convenient for you to discuss suitable
molecule(s) to test our process?

Thanking you in advance for your assistance on these two matters,

Emilio Squillante III, Ph.D.
Assistant Professor
Dept. of Pharmacy and Administrative Sciences
St. John's University
8000 Utopia Parkway
Jamaica, NY 11439
squillae@stjohns.edu
(718) 990-5020 fax 990-6316
Office hours: T&R 9:30 to 11:00 a.m., Wed 8:00 a.m. to 10:00 a.m.