SDP1 permits and standards for cellular ATMPs

Donors, manufacture, pharmacy and clinic....what permits are needed by who and from whom? What quality standards?

To say that producing an ATMP and delivering it in healthcare is a daunting task is an understatement, and no doubt just made the experienced product developers out there giggle. The regulatory, scientific, commercial/IP, legal agreements, manufacture, patient/donor and healthcare/clinical trials related expertise required to get this to work poses a steep learning curve for us as we move the latest in pharmaceutic science advances towards the clinic.

How will you manage!? Can it be done? Where to start? What to expect? With the resources on atmp.knowitjonkoping.se we aim to make your life easier. To provide what we know and to update this with developments in the field we have published several resources already including the ATMP Regulatory Guide by Ann Novotny and the Swelife-ATMP SDP1 team, and the Commercial aspects of ATMPs resource by Anna Ridderstad Wollberg and the Swelife-ATMP SDP3 team. These resources share knowledge and links compiled between our partners to give you a leg up in understanding what you need to consider, the steps you are taking and what forms, permits and agreements you need, or alternatively partnerships you should make. With our website upgrade in the Spring of 2021 we hope to make the value of these resources more accessible to you.

December 17th, 2020 an important resource became available and probably to most is still unknown. This was the day when Ann Novotny uploaded the PDF ”Guide: Tillståndskarta för hälso- och sjukvård” to the  SDP1 ATMP regulatory guide under ”Guides and Documents”.

ATMP – Guides and Documents (atmp.knowitjonkoping.se)

The arrival of this new resource was easy to miss and is still hard to find if you are not looking for it specifically. However, it is worth taking a look! We plan with our spring 2021 upgrade of our website to move this guide and other resources to a more premiere location in a more accessible format.

What is this document? In a nutshell, it maps the permits and quality standards needed ’start to finish’ to collect cellular material for ATMP production, manufacture and treat patients. (DISCLAIMER: Keep in mind of course that this guide is not legally binding and readers must check content against current legislation) 

The guide may be daunting at first, but once you understand the layout of the document it is quite self explanatory and full of valuable information. The following is an English summary of the document to assist you in finding information relevant to your activities.

There are 18 slides in the PDF, the first summarises the phases of development and the permits and quality standards needed at each step with links to relevant legislations and regulations.

Slide 2: Lists the consents and relevant information/links needed for donation of cellular material including consent to;

• donation for pharmaceutical production
• collection of personal data
• clinical trial with an autologous product, where relevant.
• sample biobanking, where relevant

Slide 3: An explanation of the requirements for units collecting donor material.

Slide 4: Information on the MPA ’Tissue Establishment’ license for receival of start material and Export/Import permits if relevant.

Slides 5 and 6: Makes you appreciate using a CMO service or facility like Vecura, listing the permits needed by a manufacture facility, including;

• MPA manufacture permit – incl. dose preparation of ready-made pharmaceutical where relevant (see slide 7)
• Wholesale permit for the storage and distribution of pharmaceuticals in Europe
• Good Distribution Practice (GDP) distribution of pharmaceutical guidelines
• GMO application to Arbetsmiljöverket, where relevant (see slide 8)
• Import of ATMP from a 3rd party country, where relevant.

Slide 7: Outlines the Hospital Pharmacy handling functions upon receiving the pharmaceutical product from the manufacturer.

• dose preparation of ready-made pharmaceutical where relevant
• permit from the MPA as a hospital pharmacy function to dispense pharmaceutical to clinics
• suitable storage facilities – or agreement with hospital department or subcontractor with suitable facilities

Slide 8: Is what is needed in the clinic for receival and administration to patients;

• if dose preparation of ready-made pharmaceutical will be done in the clinic – qualified personell following Socialstyrelsens regulations on prescription and handling of pharmaceuticals in healthcare
• Good Clinical Practice (GCP) for handling of clinical trial pharmaceutical
• Approved application for clinical trial from MPA – including where relevant GMO approval
• Approved ethical review from Etikprövningsmyndigheten for clinical trial
• Where relevant training of healthcare staff by manufacturer to qualify the staff for handling of the ATMP

Slide 9: Consents required from patients participating in clinical trials including consent to;

• treatment within clinical trial or with market approved or hospital exemption pharmaceutical
• use of follow up samples for future research (optional)

Slides 10-18: Outline examples where permits may or may not be relevant for market approved ATMP, clinical trial investigational ATMP or hospital exemption cell based pharmaceuticals.

• Examples include non/GMO, internal/external manufacture and autologous treatment under hospital exemption.