Author Archives: Maribel Rios

eBook: Raw Materials Quality, Processing, and Storage — A Manufacturing Case Study

Raw material storage, handling, and processing are essential to ensure high product quality and consistent process performance. Slight variabilities in raw materials (either inherent in the material or through processing) can compromise yield and even result in batch loss. On Tuesday 26 September 2017 speakers at the BioProcess International Conference (part of Biotech Week Boston) addressed raw material variability and control strategies in biomanufacturing. They discussed the industry’s initiative for raw material risk assessments and strategies to control variability by…

eBook: Innovations in CRISPR Technology — A Perspective on Research and Bioprocess Applications

One of the fastest growing areas in genome engineering is research using the powerful editing tool of clustered regularly interspaced short palindromic repeats (CRISPR). When paired with the Cas9 (CRISPR-associated protein 9), an RNA-guided DNA endonuclease enzyme from Streptococcus pyogenes, the site-specific prokaryotic immune system can be used to cut and manipulate DNA strands in cells of patients with genetic diseases to treat, or in some cases, prevent such diseases. Within the past couple of years, CRISPR has been shown…

December From the Editors

On the night of Wednesday, 27 September 2017, the fourth annual Battle of the Biotech Bands raised US$110,000 for the bands’ selected charities. More than 800 guests enjoyed refreshments at the Royale Nightclub in Boston and watched Led Zymmelin (pictured right, representing Sanofi Genzyme) walk away with the top prize. They raised money for the National Organization for Rare Disorders (NORD). The crowd was a mix of Biotech Week Boston attendees; arts and entertainment critics; developers, contractors, architects, engineers, furniture…

Advanced Control Strategies at Biotech Week Boston

Attendees at this year’s Biotech Week Boston (24–28 September) had the opportunity to participate in several preconference symposia on the first day, including one on advanced control strategies for bioprocessing and biomanufacturing. Chaired by William Whitford (GE Healthcare), the session included presentations from Dan Kopec (Sartorius Stedim Data Analytics), Markus Gershater (Synthace), Jonathan Bones (National Institute for Bioprocessing), Robert Thomas (Loughborough University), Chris McCready (Sartorius Stedim Data Analytics), and Victor Konakovsky (Newcastle University). BPI has collaborated with conference organizer KNect365…

Introduction: Emerging Therapies Come of Age

According to a 2017 industry report, 74% of biopharmaceuticals currently in development (phase 1–3) are possible first-in-class medicines (those that use a unique mechanism of action), thus representing a potential new pharmacological class of treatment (1). They include regenerative medicines, conjugated monoclonal antibodies (MAbs), and DNA and RNA therapeutics. Some emerging therapies — such as antibody–drug conjugates (ADCs) and biobetters — have been more at the forefront of discussions than others, but all are poised to bring exciting changes to…

Process Needs of Antibody Fragments and Bispecifics: A Discussion with Jonathan Royce of GE Healthcare

Although the number of bispecific antibodies approved so far (two) and antibody fragments either approved or with an investigational new drug (IND) filed (∼20, both antigen-binding and variable) are far below the number of approved and candidate monoclonal antibodies (MAbs), research in both fragments and bispecifics continues to look promising. And as Jonathan Royce, business leader for chromatography resins at GE Healthcare, discusses here, both offer specific therapeutic advantages over MAbs. But manufacturers should be aware that their diverse structures…

Developments in Antibody–Drug Conjugates: A Discussion with Thomas Ryll of ImmunoGen

As a major class of emerging therapies, antibody-drug conjugates (ADCs) already have gained the attention of biopharmaceutical researchers and manufacturers because they combine both the precision of monoclonal antibodies and the potency of highly potent drug compounds. A few ADCs already have entered the market, but many more candidates are progressing through industry pipelines. Platform processes are not yet universal (and it remains to be seen whether they ever will be), but major ADC developers are establishing their own with…

Strategies for Successful Sample Transfer

Nadine Ritter is president and senior analytical advisor of Global Biotech Experts, LLC and a long-time member of BioProcess International’s editorial advisory board. At a recent CASSS North American CMC Strategy Forum called “Methods on the Move: Addressing Method Transfer Challenges,” she discussed the biopharmaceutical industry’s logistical challenges of analytical test samples for drug substances and products. At the conference, BPI’s editor in chief Anne Montgomery met with her to discuss some key points of this topic. Logistics Challenges Montgomery:…

Introduction: Process Issues in Cell, Gene, and Tissue Therapies

It’s hard to believe that just six years ago, BioProcess International published its first cell therapy supplement, which included just one article on “cell therapy bioprocessing” (1). At the time, most such processing was conducted in special clinical laboratories and academic institutions. As BPI continued to cover this relatively new segment of the biopharmaceutical industry, we heard more about “the product is the process” and “scale out instead of scaling up.” After many trials, errors, and milestones, regenerative medicine has…

Expansion Platform Components

I first met Chris Mach at the Biotech Week Boston conference in October. We discussed the challenges that biomanufacturers are facing in cell expansion, especially in three specific areas in scale-up systems. View the full article below – Login Required