7
Downstream
thirty seven
Regulatory issues
have a crucial role in every biotech-drug
process. Regulatory guidelines assure the development and
production of a safe product. Nadine Ritter (Biotechnology
Product Consultant) delivered an excellent lecture, presenting
some complex regulatory issues in a very comprehensible way. Her
matrix treatment of the Current FDA CMC requirements for the
development of new plasma products: what to do and when made
light work of a heavy subject. Andrew Chang (FDA) discussed
comparability studies for human plasma-derived therapeutics
while a European perspective of the safety of biotech and plasma
products was presented by Hannelore Willkommen. Although
techniques such as PCR are becoming standard for testing raw
materials, complementary evaluations of the manufacturing
processes for their ability to inactivate or removal viral agents are
also within the regulatory boundaries, reported Dominique Pifat
(Bayer Healthcare).
Successes and set-backs are the reality of clinical trials. Reinhard
Burger (Robert Koch-Institute) related a case where a recombinant
adenovirus used for gene therapy resulted in the patient's death
due to complement activation. Joe Bertolini (CSL, Ltd) on behalf of
(Peter Lerch, ZLB Bioplasma) presented the development of a
reconstituted HDL that that showed a range of activities for
several areas of clinical application, including, cardiovascular,
cerebrovascular and inflammatory diseases.
Bioterrorism has created the need to quickly develop and
manufacture countermeasures. William Labossiere Bees (Cangene
Corp) described an approach to meet such urgent needs which
comprised a multi-departmental product team working
concurrently; outsourcing, key decision makers and regulatory
agencies brought in during development; and process scale-up
concurrent with scale-up of plasma collection activities. Improving
an existing manufacturing process can increase yield by 40%.
Wytold Lebing (Bayer Corp) reported the improvements made to
the Alpha-1P1 process. David Lewin (Bio Products Laboratory)
presented the development and scale-up of a process for Alpha-1-
acid glycoprotein using conventional plasma processing that does
not compromise the manufacture of any other commonly
recovered plasma protein. The product is currently in clinical trials.
PPB provides a forum for open
discussion of the needs, the
trends, the challenges, and the regulatory issues impacting all
those working with and researching into plasma products. The next
meeting can't come soon enough. Look out for details for PPB 05
at a venue in the Mediterranean.
Extended Reports from the meeting
Many of these exciting presentations have been captured in a special
issue of DownstreamTM, entitled Downstream PPB 03 abstracts Code
number 18-1177-96.
The booklet is a compilation of extended reports written by the
presenters at this meeting and it gives the reader an opportunity to
follow the latest trends and developments within the plasma
fractionation industry. The booklet can also be downloaded from our
website.
