In 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.
Reliable, Consistent Supply of Essential Reagents
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 â€” 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 pharmaceutical ingredients (APIs) in an audited facility is what we come to work for every day. It stands to reason, then, that we know how to consistently supply the component reagents that make this level of manufacturing possible.
Regularly audited by customers and the FDA alike, with a number of drug master files (DMFs) under our belt, we supply 16 of the top 20 pharmaceutical and biotech companies in the world. But that doesn’t stop us from large-scale chemical synthesis or natural extractions in our three separate facilities. And it’s the same attention we give medium and small biotech and diagnostic companies. We understand that if discerning researchers, developers, and supply chain managers have access to the best components, they can help their organizations grow too. So it’s important for us to supply whatever format and grade necessary.
MPEGs: An Example
There are a limited number of MPEG producers worldwide, and the nature of their exclusive supply agreements limit availability. BioVectra has a secure long-term source for 10, 20, and 30. Our proprietary purification technology allows the achievement of high-quality MPEG-OH. In short, BioVectra has developed a secure, stable source of high-quality raw materials for its MPEG reagent offering. We have provided the following to various customers:
- 30-g batch of 3-kDa material to a phase 2 trial
- 1.5-kg and 5-kg batches for phase 3 supply of 20-kDa propionaldehyde
- 500-g batches of proprietary 20-kDa MPEG for phase 3 trials
- 5-kg batches for 5-kDa derivative for phase 3 trials
- 200-g batch of proprietary branched derivative for phase 1 clinical trials
- Multiple laboratory-scale productions for evaluation
- Scaled MPEG-OH purification for production (20- to 30-kg batches).
BioVectra and Quanta Biodesign
BioVectra has been appointed by Quanta Biodesign as a strategic marketing and sales partner for Quanta’s discrete 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 cGMP capabilities, and the partnership allows an impressive array of capabilities.
Quanta Biodesign is a research and manufacturing company committed to the development of a full range of discrete polyethylene glycol (dPEGÂ®) PEGylation reagents for applications in diagnostics, therapeutics, peptide and oligonucleotide synthesis, and nanotechnology. The term dPEG is Quanta’s trademarked acronym for â€śdiscrete PEG.â€ť Each product represents a single compound with a unique, specific, single molecular weight (MW) PEG synthesized de novo from pure, small units (e.g., triethylene glycol or tetraethylene glycol).
Quanta Biodesign’s vision incorporates a dedicated commitment to producing the most useful compounds for your current and future applications and needs using synthetic and process technology that allows the most economic incorporation of these products into cutting-edge pharmaceutical applications.
Range and Experience
It might be DTT in molecular biological grade, TCEP cGMP, nonanimal IPTG, or hundreds of other sophisticated, high-purity reagents â€” or it might be a new compound that needs a synthesis route and a reliable manufacturing scheme â€” we’re ready to work closely with the people who know exactly what they need: our customers. BioVectra is an experienced, cGMP manufacturer of APIs and select final drug products. Both its internal materials and product packaging processes and 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; firstname.lastname@example.org.