Alfa Laval AB · OMXSTO:ALFA
Alfa Laval AB — Technical Presentation (August 2021)
29 slides from Alfa Laval AB's technical presentation, Aug 26, 2021
Slide 1: Optimize your biopharmaceutical productivity with mixing and high speed separator solutions
Optimize your biopharmaceutical productivity with mixing and high speed separator solutions 26 August 2021 01/09/2021 | © Alfa Laval 1 | www.alfalaval.com
Slide 2: An expert in pharmaceutical industry
An expert in pharmaceutical industry • Alfa Laval’s presence in the pharmaceutical industry is dated back for more than 100 years ago • We provide an extensive range of proven components and systems in fluid handling components, separation systems and heat exchangers • We offer sustainable solutions
Slide 3: Promising growth in the pharmaceutical industry
Promising growth in the pharmaceutical industry Pharmaceutical industry revenues • Biopharma estimated CAGR (Compound Annual Growth Rate) of 10% (2021-2026) • 30% of the total pharma market 2020 • Predicted to reach 35% by 2026 • Dominated by proteins (antibodies and insulin) • New segments such as
Slide 4: Reactor mixing, mixing optimization, high-speed separation, single-use separation
• Reactor mixing to secure optimized condition for your culture • Mixing optimization for quality and cost improvements • Improve your harvesting processes with high-speed separation • Optimize your operations with single-use separation 01/09/2021 | © Alfa Laval 4 | www.alfalaval.com
Slide 5: Our speakers
Our speakers Per-Åke Olsson is the Global Industry Manager for Pharma & Biotech in Alfa Laval. He holds a MSc, Mechanical Engineering from University of Lund, Sweden and eMBA from University of Warwick, United Kingdom. He was also the Member of the Pharmaceutical Technology Europe editorial advisory
Slide 6: Securing optimized mixing conditions for your cell culture to boost yield and productivity
Securing optimized mixing conditions for your cell culture to boost yield and productivity Per-Åke Olsson Global Industry Manager - Pharma & Biotech 01/09/2021 | © Alfa Laval 6 | www.alfalaval.com
Slide 7: Mixing in biopharmaceutical processing
Mixing in biopharmaceutical processing Media Preparation Buffer Preparation Utilities Seed Train Buffer Hold Harvesting Purification 01/09/2021 | © Alfa Laval 7 | www.alfalaval.com
Slide 8: Reactor - Bacteria vs. Mammalian cells
Reactor - Bacteria vs. Mammalian cells Parameter Fermentor Bioreactor Platform Bacteria cells* e.g. E-coli Mammalian cells e.g. CHO (Chines Hamster Ovary) Manufacturing cost Medium High Drug substances Intra-cellular Typically, Extra-cellular Concentration in tank High concentration Low concentratio
Slide 9: Fermentor & Bioreactor
Fermentor & Bioreactor Fermentor Bioreactor 01/09/2021 | © Alfa Laval 9 | www.alfalaval.com
Slide 10: Critical factors for cell growth
Critical factors for cell growth Critical factors Fermentor Bioreactor Homogeneity (nutrition, pH, temperature) Less sensitive Sensitive Gas dispersion (O2 & CO2) Important Less importance Shear Less sensitive Sensitive Heat transfer Less sensitive Sensitive Sterility Less sensitive Sensitive 01/09/
Slide 11: How to select the right mixer?
How to select the right mixer? Mixing theory Q = Pumping capacity (m3/min) Impeller type NP NQ NQ/NP P = Power consumption (W) Rushton 5.20 0.72 0.14 NQ= Pumping number (unit-free) Pitch Blade Turbine (45°) 1.27 0.79 0.62 NP= Power number (unit-free) Hydrofoil 0.30 0.56 1.87 D = Impeller diameter (m
Slide 12: Mixing in fermentor's & bioreactor's
Mixing in fermentor’s & bioreactor’s Fermentor mixing Bioreactor mixing • High power input (>5 kW/m3) • Low power input (<1kW/m3) (shear sensitive) • Radial impellers (Rushton or Smith turbines) are • Axial/radial flow hydrofoil impellers with high mixing common – high speed and shear capacity (but
Slide 13: Magnetic mixer in bioreactor's
Magnetic mixer in bioreactor’s Characteristics: − Aseptic − Close clearance, effective mixing − Bottom mounted, easily accessible − Up to 20-30 m3 − Low tank (H/D ≥ 1.5) 01/09/2021 | © Alfa Laval 13 | www.alfalaval.com
Slide 14: Buffer, Media & Nutrient mixing – Quality & Cost
Buffer, Media & Nutrient mixing – Quality & Cost Challenges: • Large volumes to mix • Labor intensive • Large floor space occupied Requires: • Fast & efficient mixing • Complete and homogenous mixing • Low energy consumption • Mixing to last drop • Bioburden control 01/09/2021 | © Alfa Laval 14 | ww
Slide 15: Alfa Laval Agitators & Mixers
Alfa Laval Agitators & Mixers Agitators Magnetic Mixers Powder Mixers - ALT - LeviMag UltraPure - Hybrid Powder Mixer M15 - ALB - Hybrid Powder Mixer S15 - ALS - ALTB 01/09/2021 | © Alfa Laval 15 | www.alfalaval.com
Slide 16: Don't hesitate to contact us
Don’t hesitate to contact us for: • Reactor mixing to secure optimized condition for your culture • Mixing optimization for quality and cost improvements 01/09/2021 | © Alfa Laval 16 | www.alfalaval.com
Slide 17: Separation solutions for biopharma application
Separation solutions for biopharma application Xiaoguang Li Global Sales Manager - Biopharma 01/09/2021 | © Alfa Laval 17 | www.alfalaval.com
Slide 18: Separation technologies in biopharma applications
Separation technologies in biopharma applications • Disc stack separator is efficient, big in capacity, and low in operation cost • High speed disc stack separator is a centrifuge for liquid-solid, liquid-liquid, liquid- liquid-solid mechanical separation • It’s a unique separation equipment based o
Slide 19: Current challenges to the disk stack separator in biopharma applications
Current challenges to the disk stack separator in biopharma applications 1. Temperature pick up during separation 2. High feed solid content and high viscosity of solid 3. Mammalian cell culture separation 4. Clean validation to separation system 01/09/2021 | © Alfa Laval 19 | www.alfalaval.com
Slide 20: 1. Temperature pick up during separation
1. Temperature pick up during separation • Typical feed: probiotics, virus Solution: Full hermetic separator, less temperature for vaccines pickup because of no air contact with product • Challenge: denaturing the target protein and decline the bio- active of protein, then generate less product valu
Slide 21: 2. High feed solid content and high viscosity of solid
2. High feed solid content and high viscosity of solid • Typical feed: Pichia yeast Solution: Improve the product yield in the washing step • Challenges: - High fermentation density, solids content ~50%PCV, reach discharge interval limitation - High viscosity in solid phase due to high concentration
Slide 22: 2. High feed solid content and high viscosity of solid (cont.)
2. High feed solid content and high viscosity of solid (cont.) Liquid phase to next step Fermenter A B Washing water Feed pump mixer solids phase Solids tank 3 stages count-current Pichia yeast washing line 01/09/2021 | © Alfa Laval 22 | www.alfalaval.com
Slide 23: 3. Mammalian cell culture separation
3. Mammalian cell culture separation • General aspects: Extra cellular proteins, high-value drug • Solution: Full hermetic separator, gentler treatment and lower shear force • Separation aspects: - Large compared to bacteria (10-20 micron) - Extremely shear sensitive because without cellwall protect
Slide 24: 3. Mammalian cell culture separation (cont.)
3. Mammalian cell culture separation (cont.) − Additional lysis shall be minimized LDH = Lactate dehydrogenase, an enzyme indicate the cell lysis level 01/09/2021 | © Alfa Laval 24 | www.alfalaval.com
Slide 25: 4. Clean validation to separation system
4. Clean validation to separation system • General aspects: • Solution: Single-use separator - Concerning about aseptic operation, the structure of disc stack separator is complicate, it’s difficult to be completely cleaned by means CIP and pass through the CIP validation. - Separator clean validati
Slide 26: 4. Clean validation to separation system (cont.)
4. Clean validation to separation system (cont.) − Single-use separator • Small scale production meets upscale performance with single-use separator; CultureOne • It is a disc stack full hermetic separator • CHO cell separation capacity: up to 250l/h. • Solid phase continuously discharge. • Doesn’t
Slide 27: Our references from around the world
Our references from around the world Customer uses Alfa Customer uses Alfa Laval module with SIP Laval separation for flu vaccine module to treat living manufacturer in cell in Lonza (UK) Indonesia Janssen uses Alfa Laval Alfa Laval handed over CultureOne single use two separation modules separator
Slide 28: Summary of the key benefits of Alfa Laval's separators in biopharma applications
Summary of the key benefits of Alfa Laval’s separators in biopharma applications • Higher separation efficiency by means of more gentler treatment and lowest shearing force • Higher product yield by less temperature pickup during separation low extra lysis and washing • Higher biosafe (hygienical) l
Slide 29: Reactor mixing, mixing optimization, high-speed separation, single-use separation
• Reactor mixing to secure optimized condition for your culture • Mixing optimization for quality and cost improvements • Improve your harvesting processes with high-speed separation • Optimize your operations with single-use separation 01/09/2021 | © Alfa Laval 29 | www.alfalaval.com