Biochemicals and Raw Materials

Grade, Range, and Format

The Importance of Bioprocessing Reagents

I
n pharmaceutical and biochemical manufacturing
processes, the emphasis is on knowable quality levels,
defined components, and predictable, repeatable yields
and products. This underlines the importance of reliable
specification and quality claims, whether they point to cGMP,
molecular biology grade, high purity, or simpler grades. The
point is to be what they are claimed to be. Naturally, it is not a
question of the highest purity possible, but rather the highest
purity necessary at a cost that makes sense. It’s all part of
driving high-level processes to reliable endpoints, of a
sustainable manufacturing scenario that reduces costly
repurifications, workloads, and QC failures.

R eliable, Consistent
Supply of Essential R eagents
Hand in hand with this concept, of course, is the idea of a
reliable, consistent supply of essential or crucial reagents. We
have made it more than an idea. Forty years of dedication to
becoming reliable, consistent, and flexible isn’t a marketing
statement — just a historical fact. We understand the rigors of
pharmaceutical manufacturing under a strict regulatory regime
that our customers face every day because, as a matter of
record, we face it too. Making high-potency, cytotoxic active MPEGs: An Example
pharmaceutical ingredients (APIs) in an audited facility is what
There are a limited number of MPEG producers worldwide, and
we come to work for every day. It stands to reason, then, that the nature of their exclusive supply agreements limit
we know how to consistently supply the component reagents availability. BioVectra has a secure long-term source for 10, 20,
that make this level of manufacturing possible. and 30. Our proprietary purification technology allows the
achievement of high-quality MPEG-OH. In short, BioVectra has
R egularly Audited developed a secure, stable source of high-quality raw materials
Regularly audited by customers and the FDA alike, with a for its MPEG reagent offering. We have provided the following
number of drug master files (DMFs) under our belt, we supply to various customers:
16 of the top 20 pharmaceutical and biotech companies in the • 30-g batch of 3-kDa material to a phase 2 trial
world. But that doesn’t stop us from large-scale chemical • 1.5-kg and 5-kg batches for phase 3 supply of 20-kDa
synthesis or natural extractions in our three separate facilities. propionaldehyde
And it’s the same attention we give medium and small biotech • 500-g batches of proprietary 20-kDa MPEG for phase 3 trials
and diagnostic companies. We understand that if discerning
• 5-kg batches for 5-kDa derivative for phase 3 trials
researchers, developers, and supply chain managers have
• 200-g batch of proprietary branched derivative for phase 1
access to the best components, they can help their
clinical trials
organizations grow too. So it’s important for us to supply
whatever format and grade necessary. • Multiple laboratory-scale productions for evaluation
• Scaled MPEG-OH purification for production (20- to 30-kg
R ange and Experience batches).
It might be DTT in molecular biological grade, TCEP cGMP,
nonanimal IPTG, or hundreds of other sophisticated, high-

14 BioProcess International Industry Yearbook 2012–2013 advertorial

 Experience
Versatility
BioVectra is an original
manufacturer with 42 years of
BioVectra and Quanta Biodesign
experience and FDA inspected
BioVectra has been appointed by Quanta Biodesign as a
strategic marketing and sales partner for Quanta’s discrete facilities in Canada.
PEGs product line. BioVectra will actively promote Quanta’s
unique offering of discrete PEG products to our international
network of agents and key customers. BioVectra gives Quanta High-Purity, cGMP quality, non-animal or
cGMP capabilities, and the partnership allows an impressive
array of capabilities.
BSE controlled BioProcessing reagents
Quanta Biodesign is a research and manufacturing company available in a wide range of grades
committed to the development of a full range of discrete
polyethylene glycol (dPEG®) PEGylation reagents for
applications in diagnostics, therapeutics, peptide and
• IPTG: Dioxane free and non-animal
oligonucleotide synthesis, and nanotechnology. The term dPEG grades
is Quanta’s trademarked acronym for “discrete PEG.” Each
product represents a single compound with a unique, specific, • DTT: Molecular grade, commercial
single molecular weight (MW) PEG synthesized de novo from
pure, small units (e.g., triethylene glycol or tetraethylene scale capability
glycol).
Quanta Biodesign’s vision incorporates a dedicated • DTE, TCEP, EDAC
commitment to producing the most useful compounds for
your current and future applications and needs using synthetic • Enzymes: Adenosine Deaminase,
and process technology that allows the most economic
incorporation of these products into cutting-edge
Cholesterol Esterase, GLDH
pharmaceutical applications.
• MPEG reagents low poly-disperse,
purity reagents — or it might be a new compound that needs a mono-disperse, and discrete PEGs,
synthesis route and a reliable manufacturing scheme — we’re higher molecular weight MPEG
ready to work closely with the people who know exactly what
they need: our customers. BioVectra is an experienced, cGMP
reagents
manufacturer of APIs and select final drug products. Both its
internal materials and product packaging processes and
...and many others
external product distribution system are established to provide
the level of controls necessary in handling products under
controlled distribution conditions.
Talk to us or come visit us at www.biovectra.com. We’d be
happy to tell you more but even happier to hear what you have
to say. •

Lee DesRosiers is in bioprocess reagent business development at

BioVectra Inc., 11 Aviation Avenue, Charlottetown, PE Canada C1E 0A1;
1-866-883-2872; ldesrosiers@biovectra.com.
BioVectra Inc.
(902) 566-9116 or (866)-883-2872
info@biovectra.com

www.biovectra.com