How a release document is put together in a regulated plant
The purity figure is the least informative line on a well-constructed certificate and the only line most buyers read.
Fill & finish
Page 10 of 11 of this archive, newest first.
Who signed this, and what did they undertake by signing it
What the Journal asks when a document arrives unsigned, and what the answers have been.
The anatomy of the most reproduced page in this trade
The purity figure is the least informative line on a well-constructed certificate and the only line most buyers read.
Four ways a peptide comes apart
We describe each pathway in enough chemical detail to explain why it is invisible to the method the trade uses, because that is the part which has practical consequences.
Endotoxin is not a microorganism, and killing the bacteria does not remove it
Three compendial method families are in routine use and a fourth, based on a recombinant enzyme rather than crab lysate, is now compendial in its own right.
The anatomy of the most reproduced page in this trade
Nothing on this page is difficult. It is simply unfamiliar, and unfamiliarity is what makes a weak certificate look like a strong one.
What we are not saying about anybody in this trade
None of what this piece asks for is commercially sensitive, and all of it is already known to whoever released the batch.
What the paperwork is for, and who it was designed to protect
The header identifies the batch, the table records the tests, and the footer says who is answerable. Two of the three are usually incomplete.
Why a dead-clean sterile filter can pass pyrogen straight through
The masking phenomenon known as low endotoxin recovery means a formulation can return a clean result while containing endotoxin the assay cannot see.
The fourteen-day problem, and what it does to a commercial testing model
We asked all four services what they can determine, on what timescale, at what price, and under what accreditation. The answers are printed in full.
What we asked twenty suppliers about stability data
We asked twenty companies three questions about stability data and print every answer, refusal and non-response.
A document, not a test: what a certificate actually is
Nothing on this page is difficult. It is simply unfamiliar, and unfamiliarity is what makes a weak certificate look like a strong one.
Retest date, expiry date, and the two conventions being confused
A document is only as good as the chain that connects it to the material, and most chains here are two or three links longer than the paperwork admits.
Four ways a peptide comes apart
We describe each pathway in enough chemical detail to explain why it is invisible to the method the trade uses, because that is the part which has practical consequences.
Twenty-eight days is a number from somebody else’s product
We set out what is known, what is inferred and what is simply assumed about the fortnight after a vial is opened.
How a release document is put together in a regulated plant
Nothing on this page is difficult. It is simply unfamiliar, and unfamiliarity is what makes a weak certificate look like a strong one.
What the sequence tells you about how a peptide will fail
The sequence predicts the failure mode. A methionine predicts oxidation; an asparagine followed by a glycine predicts deamidation; a cysteine predicts disulphide scrambling.
Who signed this, and what did they undertake by signing it
What the Journal asks when a document arrives unsigned, and what the answers have been.
Four ways a peptide comes apart
Deamidation, oxidation, aggregation and hydrolysis account for nearly all of what happens to a peptide over time. Each has a characteristic residue, a characteristic…
Oxidation, and the peroxide that came in with the surfactant
The sequence predicts the failure mode. A methionine predicts oxidation; an asparagine followed by a glycine predicts deamidation; a cysteine predicts disulphide scrambling.