2012 Anniversary Retrospectives

The year 2012 is BioPharm International's 25th Anniversary. Each month, we will be reviewing articles from the journal's first volume and discussing what's changed in key technical areas of the biopharmaceutical industry. In addition, below are a few special roundtables featuring industry experts about what they have witnessed in areas such as upstream and downstream processing, analytical technologies, contract relationships, regulations, biologic drug approvals, and more. Plus: what's in store for the next 25 years.

A 25-Year Retrospective on Computer System Validation
This month, Sharon Strause, an industry consultant, provides a look back at "Computer System Validation Part I: Testing and Verification of Applications Software" by Leonard J. Goren.
Read the 2012 retrospective.

A 25-Year Retrospective on Protein Recovery through Membrane Filters
This month, Jerold Martin of Pall Life Sciences takes a look at protein recovery through direct-flow microporous membrane filters over the past 25 years.
Read the 2012 interview. Read the original article.

A 25-Year Retrospective on Cleanroom Management
Anne Marie Dixon of Cleanroom Management Associates, gives us an update on her 1988 article, "Clean Room Management."
Read the 2012 interview. Read the original article.

A 25-Year Retrospective on Bioprocessing mAbs
Michiel E. Ultee of Laureate Biopharmaceutical Services gives an update on 1988 article regarding virus testing and how the advance of monoclonal antibodies has changed processes.
Read the 2012 interview. Read the original article.

A 25-Year Retrospective on Orphan Drugs
This month, Michael N. Abrams, managing partner at Numerof & Associates, gives an update on "Product Development and Registration, Part IV: Special INDs and Marketing Applications," written by Nancy J. Chew in 1988, and the rise of orphan drugs.
Read the 2012 interview.

A 25-Year Retrospective on Bio-Engineering
Steven S. Kuwahara, PhD, principal consultant at GXP BioTechnology LLC, gives an update on "Engineering the Cell-System Interface." Read the original article.

25 Years of BioPharma Industry Growth
The biopharma industry remains a vibrant and exciting segment, partly because of the promise it holds for a better future for each of us. Much of the energy comes from the dedication of this industry's participants: from its inventors, to its managers, to its innovative suppliers. This article provides a review of key industry shifts and promises for the future.

25 Years of Biopharmaceutical Innovation: Expert Roundtable
In this article, BioPharm's Editorial Advisory Board members are asked about significant changes in the industry.

25 Years of Nanoparticles: A Look Forward
Panayiotis P. Constantinides of Biopharmaceutical & Drug Delivery Consulting on growth of nanoparticle delivery systems.
Read the 2012 interview.

25 Years of Protein Expression
Charles H. Squires of Pfenex discusses advances in expression platform solutions.
Read the 2012 interview.

New Biopharmaceuticals
A review of new biologic drug approvals over the years, featuring highlights from 2010 and 2011.
Read the 2012 article.

FDA Adopts New Strategies to Oversee Global Economy
An interview with FDA Deputy Commissioner Deborah Autor.
Read the 2012 interview.

A 25-Year Retrospective on the Biotech Business
We rewind to an article titled "The BioTechnology Industry" by G. Steven Burrill, who now writes the journal's "Burrill on Biotech" column and is head of the global financial services firm Burrill & Company. The following is an abstract of the original article, looking at "new" issues and concerns facing the industry back in 1988.
Read the 2012 interview. Read the original article.

A 25-Year Retrospective on GMP Training
In the past 25 years, there have been many changes in GMP Training. These changes were not in the GMP training concepts themselves, but in the "c" in cGMP. It is the practical applications of training that have changed over the years. Some changes were subtle; some were more drastic (and even dramatic). But all can be summarized in three words: technology, technology, technology.
Read the 2012 interview.

A 25-Year Retrospective on the Public's Perception of the Biopharmaceutical and Biotech Industry
The 1988 article discusses how the general public viewed science, and biology in particular, at the time it was written. "Even educated people remain wary of the new biology and a host of mysteries such as recombinant DNA and monoclonal antibodies" and "People do not understand what is occurring in the nation's laboratories," were just a few of the comments made by the author, Leonard Anderson. BioPharm asked its Editorial Advisory Board members to comment on how far the world has come in respect to understanding, acknowledging, and supporting the work of biotechnology. We also asked our board members whether they think the industry has done a better job of informing the public about its work and products, as the author suggested 25 years ago.
Read the 2012 interview.

A 25-Year Retrospective on Mammalian Cell Culture
Twenty-five years ago, as today, selection of the bioreactor used for large-scale cell culture was a key component of the success of the production process. Kim L. Nelson, PhD, the orginal author of the paper, now director of strategic consulting at CRB Consulting Engineers talks to BioPharm International about bioreactor design for large-scale mammalian cell culture.
Read the 2012 interview. Read the original article.

A 25-Year Retrospective on Separations Technology
This article identified the major challenges with membrane technology as "considerable fouling from solids in the solution that clog the membrane, molecular weight and pore size specifications that often are inaccurate because of the inexact process of membrane fabrication, and vulnerability of membranes to degradation after repeated sanitization steps". BioPharm International talked to Michiel E. Ultee, chief scientific officer at Laureate Biopharmaceutical Services and a member of Biopharm International's Editorial Advisory Board, about what's changed since the article's publication.
Read the 2012 interview. Listen to the full interview podcast. Read the original article.

BioPharm Celebrates 25 Years
In this online extra, Board Members comment on major industry changes over the past few decades.
Read the original article.