Thursday, 24 June 2021

Re-imagining TB care by deploying blended finance investments in TB affected countries

The Stop TB Partnership and Bamboo Capital Partners, an impact investing platform, signed a partnership agreement to support small- and medium-enterprises and start-ups, particularly from TB affected countries, developing impactful health technologies for TB, COVID-19, and TB co-morbidities.

The HEAL fund, a US$ 75 million blended finance investment vehicle, will leverage US$ 15 million in catalytic funding to incentivize and unlock US$ 60 million of private institutional investment capital. This fund will focus on providing early-stage financing for innovations that will transform health systems by catalyzing community- and home-based care for all people, including the most marginalized communities.

As part of this partnership, in addition to providing capital to innovators to further commercialize their solutions and unlike other impact investment funds, the Stop TB Partnership’s Accelerator for Impact (a4i) platform, with support from the Country & Community Support for Impact team and TB REACH initiative, will provide fit-for-purpose product launch/technical support for critical downstream activities to optimize and accelerate the roll-out of these impactful health technologies.


 "Even prior to COVID-19, the Stop TB Partnership has been at the forefront of leveraging digital health technologies to make it as convenient and easy as possible for people to access TB care,” said Dr. Lucica Ditiu, Executive Director of the Stop TB Partnership. “We need to move away from a model where people need to travel hours to access health services that can be provided at or close to people’s homes. This is why we are excited to be partnering with Bamboo Capital Partners on the HEAL fund – to make this dream into a reality.”

“The ongoing recovery from COVID-19 has emphasized the importance of technology in the fight against infectious diseases. We are therefore proud to be partnering with the Stop TB Partnership on HEAL, a fund focused on modernizing health systems and transforming how some of the poorest communities in the world access healthcare,” said Jean-Philippe de Schrevel, Founder and Managing Partner at Bamboo Capital Partners. “We are excited to work with a great, like-minded organization that is equally dedicated to creating the strongest possible impact for underserved populations in developing countries. This innovative public-private partnership will provide an unparalleled platform to succeed in advancing the United Nations Sustainable Development Goals.”

The partnership between the Stop TB Partnership and Bamboo Capital Partners falls within the context of the SDG500 platform, a US$ 500 million investment platform that aims to accelerate progress towards achieving the 17 Sustainable Development Goals across six distinct thematic investment funds. The platform already includes other United Nations agencies and non-governmental organizations, such as the International Fund for Agricultural Development (IFAD), International Trade Center (ITC), United Nations Capital Development Fund (UNCDF), and CARE Enterprises.

 Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (

Wednesday, 23 June 2021

Revised monograph Water for Injections published for public comment


The revised general monograph Water for injections (0169) has been published in this quarter’s issue of Pharmeuropa (33.2), the European Pharmacopeia (Ph. Eur.) online forum, for comment. The text has been revised to delete the tests for inorganic substances from the section on Sterilised water for injection.


This proposed deletion follows on from discussions with other pharmacopoeias in the context of international harmonisation, during which scientific evidence was provided demonstrating that if a sample meets the conductivity requirements, it also complies with the tests for inorganic substances. Consequently, the chemical tests could be deleted in favour of a single, instrument-based, quantitative test.



The possibility of revising these aspects in the section on Water for injections in bulk, as well as in Purified water (0008), is under consideration.


All interested parties are strongly encouraged to review the draft and submit their comments before the deadline, as the monograph in question covers an essential component that is used in a large number of medicinal products in Europe.


The deadline for comments is 30 June 2021.




Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (

Tuesday, 22 June 2021

Revision of PIC/S GMP Guide (PE 009-15)


The PIC/S GMP Guide to Good Manufacturing Practice (GMP) for Medicinal Products has been revised to include a new Annex 2A and 2B:

  • Annex 2A: Manufacture of Advanced Therapy Medicinal Products for Human Use (ATMP); and
  • Annex 2B: Manufacture of Biological Medicinal Substances and Products for Human Use

Annex 2A provides PIC/S GMP requirements for ATMP - it is not a standalone document but it enables reasonable harmonisation with the standalone ATMP Guidelines published by the European Commission.  Annex 2B had very minor revisions and continues to harmonise with the EU Annex 2 for human use biological medicinal substances and products. 



The revision has been successfully completed by the PIC/S Sub-Committee on the Harmonisation of GM(D)P, led by Paul Gustafson (Canada / ROEB), based on the work of the PIC/S Working Group on Annex 2. This Working Group was led by Francesco Cicirello (formerly with Australia / TGA) until May 2020 and then by Christina Meissner (Austria / AGES), who finalised the revision.

The revised GMP Guide (PE 009-15), with the new Annex 2A and 2B, will enter into force on 1 May 2021. All non-EEA Participating Authorities of PIC/S and Applicants have been invited to transpose the revised Chapters of the PIC/S GMP Guide into their own GMP Guides.

To download the revised GMP Guide (PE 009-15) see:

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (

Monday, 21 June 2021

Evaluating Pyrogen Contamination Risk


Pyrogens are commonly divided into two classes: exogenous pyrogens, such as endotoxin from Gram-negative bacteria that induce fever when applied intravenously; and endogenous pyrogens that are induced inside the body as a reaction to the contact with exogenous pyrogens and cause an elevation in body temperature (endogenous pyrogens have potent pyrogenic and inflammatory activities and include interleukin 1-a (IL-1a), interleukin-1b (IL-1b), tumour necrosis factor a (TNF-a) and interleukin-6 (IL-6)).


In this article, non-endotoxin pyrogens from exogenous source and their associated risks are the subject.



For details and to access the complete article, see:


Sandle, T. and Robert, L. (2021) Evaluating Pyrogen Contamination Risk and the Need for the MAT in Pharmaceutical Processing, Rapid Microbiology, 10th May 2021 at:


Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (

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