Biotech
From bench scale to commercial biologics production. With seamless evidence.
We guide biologics and ATMPs across CMC, scale-up, clinical development, marketing authorisation (EMA/FDA) and comparability after process changes.
Book an intro call on BiotechOverview
Biological complexity translated into a predictable development path.
- Product classes
- Biologics · ATMP
- EU authorisation
- EMA (centralised)
- Quality (ICH)
- Q5A-E · Q6B
- US market access
- FDA BLA
We support biotech companies across the entire lifecycle of a biological active substance: from bioprocess development and scale-up through CMC and comparability per ICH Q5E to the GMP manufacturing and marketing authorization of biologics, biosimilars and ATMPs at EMA and FDA. The translational hurdle rarely lies in the individual method, but in the sequence: anyone who defines Critical Quality Attributes and the comparability strategy only after scale-up has already built in the most expensive change, because in a biological process the product changes along with the process.
For decision-makers
Defining critical quality attributes and the comparability strategy only after scale-up means the most expensive change is already built in. CMC gaps are among the most frequent causes of questions during the procedure, and a deviation from the validated temperature corridor can render an entire batch unusable.
Key regulations & standards
Which standards apply in which phase?
What delays projects is rarely a missing standard, it is the sequence. This is how the requirements interlock across the entire lifecycle.
- 01
Discovery
- Cell-line and vector development
- Characterisation (ICH Q5A/Q5E)
- Non-clinical (GLP)
- 02
Process & CMC
- Upstream/downstream development
- Scale-up and tech transfer
- Comparability (ICH Q5E)
- 03
Clinical
- Phase I-III per ICH E6 (GCP)
- For ATMP: GTP/ATMP guidelines
- PV setup
- 04
Authorisation & launch
- MAA with EMA (centralised)
- FDA BLA (in parallel)
- Bio-GMP (Annex 2)
- 05
Post-launch
- Pharmacovigilance (GVP)
- Comparability after process changes
- GDP-compliant distribution
Industries
What challenges shape Biotech?
Scale-up of biological processes: the product changes with the process
Unlike chemical active substances, for biologics the process is the product. In the transition from the lab to the commercial bioreactor, glycosylation, aggregate formation and other product attributes shift. Without a clean definition of the Critical Process Parameters and Critical Quality Attributes, de-risked through Design of Experiments, process validation (PPQ) fails or produces a product outside comparability.
Comparability and CMC for biologics per ICH Q5
Every process change after characterization requires a comparability demonstration per ICH Q5E showing that the product before and after the change is equivalent. The CMC data for the biological active substance and the finished product land in CTD Module 3 and must meet the expectations of EMA and FDA regarding characterization, specifications (ICH Q6B) and stability. Gaps here are one of the most common causes of questions during the procedure.
ATMP regulatory framework for cell and gene therapies
Advanced Therapy Medicinal Products fall under Regulation (EC) No 1394/2007 and are assessed centrally via EMA and the Committee for Advanced Therapies (CAT). For autologous CAR-T products, a batch size of one patient applies, with short release times and a GMP framework that does not allow standard process validation on a one-to-one basis. The GMP requirements for ATMPs are governed in a dedicated guideline, not in the classic EU GMP Guide.
Cold chain and GDP for temperature-sensitive active substances
Biologics, mRNA-based products and cell therapies are temperature-sensitive; deviating from the validated temperature corridor can render a batch unusable. The EU guidelines 2013/C 343/01 on good distribution practice require a validated cold chain with temperature mapping and qualified transport routes. The breaking point is usually the handovers, not storage itself.
In biotech the process is the product. Every change to the process raises the question of comparability, and teams that carry CMC data and ICH Q5E comparability from the first batch never have to trade scale-up against approval later on.
Dr. Nils Sunder-Plassmann · Vice President Pharma
Why Entourage
What sets us apart from classic consultancies and freelancers.
- Industry focus100% life sciences
- Deliveryoperational, on site
- Regulatory depthGxP, FDA, EMA, MDR/IVDR
- Flexibilityproject or framework contract
- Industry focuscross-industry
- Deliverymostly strategic
- Regulatory depthgeneralist
- Flexibilitylong contract terms
- Industry focussingle niche
- Deliverysingle person
- Regulatory depthown niche
- Flexibilityday rate
Expertise
Our expertise for Biotech
Next step
Where does your project stand regulatorily?
Use our free readiness checks for a first assessment, or talk to an expert directly, without obligation.
- 100% life sciences
- 500+ projects completed
- Reply usually within one working day
Case Studies
Selected projects
Contact
Your contacts for Biotech
Dr. Nils Sunder-Plassmann
Vice President Pharma
Heads the Pharma division and advises clients on marketing authorisation and GxP compliance.
Get in touch →
Andreas Weirich
Head of Sales Pharma
Responsible for sales and key account management of partners in the pharma and biotech sector.
Get in touch →FAQ
Frequently asked questions
Sources
- Regulation (EC) No 1394/2007 on advanced therapy medicinal products (ATMP, primary text)
- Regulation (EC) No 726/2004 (centralized authorization procedure, primary text)
- Directive 2001/83/EC (Community code relating to medicinal products for human use, primary text)
- EU GMP Guide (EudraLex Volume 4), Annex 1 and Annex 2 (primary text)
- ICH Q5A-Q5E, Q6B and Q8-Q12 (primary texts of the ICH guidelines)
- EU guidelines 2013/C 343/01 on good distribution practice (GDP, primary text)
- Widget of the existing industry page (entourage-website-writer, industry-pages/biotech)
- https://theentourage.de/biotechnologie-consulting/ (existing page content, revised)
Industries
More industries
Pharma
Hands-on support across the entire lifecycle, from drug substance research to GDP-compliant distribution. On the ground, from the shop floor to the authority dossier.
Learn more →
MedTech
From product development to post-market surveillance: the EU MDR translated pragmatically into day-to-day development, for a time-critical, audit-ready market access.
Learn more →
IVD
Through the IVDR paradigm shift in clinical evidence and performance evaluation: from assay development to the post-market phase, including portfolios with 200+ products.
Learn more →Have a concrete project?
Briefly outline your situation. We'll respond with an initial assessment, usually within one business day.
Prefer direct? +39 02 8904 1000
info@theentourage.it
- Reply usually within one working day
- 4 offices: DE · CH · IT · US
- 100% life sciences