Product Handbook

Product Handbook

www.astreabioseparations.com

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ABOUT US Astrea Bioseparations is focused on bringing advanced therapies to market with industry leading bioseparation technologies. Our team has been supplying world class products for FDA and EMA approved manufacturing processes for over 30 years.

Our proprietary agarose bead technology, PuraBead®, is manufactured to ISO 9001 accredited standards. Security of supply is ensured, with in-house manufacturing capabilities of up to 1000 L batch sizes.

We support the biopharmaceutical industry with products and services that help bring life-improving and life-saving medicines to market. Regardless of process scale, we are ready to build Purity by Design into each process to ensure quality and speed to market.

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AstreAdept: A Novel Purification Method Shaping the future of cell and gene therapy manufacturing AstreAdept® brings fast flow rates and increased binding capacities to biological product purification. Higher capacity and faster runs compress bioprocessing, positively impacting on process economics.

Bioprocessing using AstreAdept® Highly accessible nanofibers allow for almost immediate access to high binding surface area at high flow rates.

AstreAdept® enables extremely high flow rates without compromising on dynamic binding capacity This technology has been incorporated into a spin column format, the Nereus LentiHERO® to bring these advantages to viral vector purification at lab-scale.

These unique features address the challenges of purifying large and fragile modalities which are often produced at low titers with high levels of contaminants.

The compact nature of nanofibers results in smaller devices, reducing physical footprint, water usage, and waste removal, leading to greener manufacturing.

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Lentiviral Vector Purification Eliminate bottlenecks in viral vector processing Utilizing AstreAdept® technology, Nereus LentiHERO® significantly reduces bottlenecks of viral vector sample preparation by compressing the processing of multiple lab-scale lentiviral feedstocks. Combining the benefits of high lentiviral particle recovery, significant reduction of contaminants, and the ability to scale out, Nereus LentiHERO® is a novel alternative to affinity resins, IEX membrane adsorbers, and molecular weight cut off ultrafiltration filters.

Lentiviral vector purification using Nereus LentiHERO®

Key Features

• Lab-scale purification of lentiviral particles in 5 steps

• High binding capacity of 1.9E+10 lentiviral particles per unit

• Easy-to-use spin column format compatible with benchtop centrifuges • Increase sample throughput by maximizing benchtop centrifuge capacity • No need for ultracentrifugation, large chromatography systems, or filtering by hand

• Over 60% recovery of lentiviral particles

• 95% reduction in host cell protein contamination • Mild process and elution conditions • Suitable for both serum and serum-free feedstocks

• Up to 10x reduction in feedstock volume • Suitable for both serum and serum-free feedstocks • Increased sample purity with reduced volumes shortens duration of subsequent concentration steps, increasing throughput of feedstock processing

Scale o

ut

60% viral particle recovery

Full use of centrifuge capabilities

95% HCP contaminant removal 10 fold reduction in volume*

Purified samples in reduced volume reduces time for concentration *dependent on feedstocks and volume used

Reduce overall process time

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Host Cell Protein Removal Simplify HCP removal from mAb workflows without reducing confidence in the purity of your product Removal of host cell proteins and product purity are critical to effective therapeutic outcomes. HCPure™ offers the platform flexibility of traditional workflows whilst eliminating process steps, sources of error and potential process bottlenecks.

Reduce process time, steps, and cost by eliminating the need for IEX and dilution of salt concentration after Protein A capture. HCPure™ can be used for sample processing from multiple different starting materials.

Key Features • High specificity for host cell proteins • Versatile mixed-mode purification techniques • Removes HMW aggregates without decreasing yield • NaOH sanitization allows for multiple cycles • Excellent flow properties

Advantages • Eliminates the need for ion exchange steps & dilution of salt following Protein A • Can be used to create a versatile purification platform that can be adjusted for variations in target analytes • Durable and easy to pack PuraBead® P6HF 90 μm base matrix exhibits stability across a wide pH range, from pH 2.0 (short term) to pH 14.0 • Cross-linked agarose beads reduce residence time, allowing finished products to be released quicker and easier Manufactured under an accredited ISO 9001 quality system with regulatory support file available, HCPure is available in pre-packed columns or as bulk resin.

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Contaminant Removal Selectively retain impurities whilst preserving yield and quality of target proteins. Our portfolio includes products which are designed to capture process-related impurities such as host-cell proteins, endotoxin, and unwanted glycosylated variants.

EtoxiClear®

IsoClear A™ and IsoClear B™

Endotoxin removal

Isoagglutinin removal

High performance affinity chromatography adsorbent capable of endotoxin clearance to ≤ 0.05 EU/mL from a range of protein solutions and final products.

Highly selective affinity chromatography resins for the efficient reduction and removal of isoagglutinins from plasma and plasma derived products.

Key Features

Key Features

• High dynamic binding capacity (>1,000,000 EU/ mL adsorbent)

• Compatible with IgM & IgG antibody isotypes

• Over 90% protein recovery • Wide operational pH range (pH 4.0 – 8.0) • NaOH stable for cleaning and depyrogenation

• Chemically synthesised A & B trisaccharide ligands mimic naturally occurring sugars on red blood cells • IsoClear A™ & IsoClear B™ can be combined to simultaneously deplete anti-A and anti-B isoagglutinins

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Application Areas

Cell & Gene Therapy

Recombinant Proteins

Contaminant Removal

Plasma Fractionation

BioProcess Optimization

Bioprocessing Columns

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Ion Exchange & Hydrophobic Interaction Chromatography Achieve maximum recovery of your target protein without compromising on purity with our ion exchange (IEX) & hydrophobic interaction (HIC) chromatography adsorbents.

Ion Exchange Chromatography Our IEX chromatography adsorbents are designed for capture, intermediate purification, & polishing steps in demanding process applications where protein separation based on net charge at a particular pH is required.

• SP PuraBead® HF & CM PuraBead® HF Strong and weak cation exchange adsorbents for the purification of positively-charged biomolecules.

• Q PuraBead HF & DEAE PuraBead HF Strong and weak anion exchange adsorbents for the purification of negatively-charged biomolecules. ®

®

Hydrophobic Interaction Chromatography A versatile purification technique utilizing hydrophobic interactions with biomolecules, particularly useful for protein purification from high ionic strength solutions.

Our range of HIC adsorbents include: • Phenyl PuraBead® HF • Butyl PuraBead® HF • Hexyl PuraBead® HF • Octyl Purabead® HF

Key Features of IEX & HIC adsorbents: • Excellent flow properties; > 600 cm/h @ 1 bar • High dynamic binding capacities • Sanitizable using Sodium Hydroxide • Available in bulk volumes suitable for GMP processes • Available in multiple formats, including RoboColumns, pre-packed columns, and slurry in pack sizes from 25 mL up to 150 L

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Bioprocess Optimization Our affinity adsorbents can be used for optimization of downstream processes across a range of diverse application areas, including antibodies, albumin fusion proteins, plasma proteins, hormones & enzymes.

Insulin Adsorbent

Mimetic Blue® SA

Reduces the number of process steps in the purification of insulin and insulin analogues, and removes the requirement for solvents used in traditional RP-HPLC purification processes.

Binds albumin and related proteins from a variety of sources including plasma, serum, and recombinant cell cultures, yielding highly purified biological products.

Key Features

Key Features • Dynamic binding capacities of over 30 g/L

• Insulin binding capacity of up to 25 mg/mL adsorbent

• Affinity ligand exhibits high specificity for albumin & related products

• Over 95% purity & over 90% recovery

• High flow and high ligand density products available

• NaOH stable for cleaning & sanitization • Selective for most forms of insulin, including single chain & two chain insulin.

Aminophenylboronate P6XL Affinity adsorbent utilising a boronic acid group used for the purification, quantification, and/or removal of glycoproteins, glycans and glycated proteins.

Used for the separation of DNA from RNA, purification of pDNA, capture of mAbs, and many other applications.

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SNAP® Chromatography Columns It’s a SNAP® High performance, easy to use hardware solutions for lab-scale applications.

Improve efficiency and productivity with the SNAP® column range.

Key Features • Quick, easy, and accurate bed height determination thanks to precision glass columns with graduated measurement scales • Compatible with high performance chromatography media and pressures up to 40 bar • Achieve a wide range of bed heights with double piston and fine thread adjustment • Linear motion of pistons eliminates torsional load on chromatography media • Quick release clamps for simple assembly and disassembly, lending to SNAP’s trademark name • Robust external inlet and outlet connections

Available in a variety of diameters and lengths to suit your process requirements, SNAP® columns are compatible with our chromatography media or your own.

Additional accessories and spare parts enable extensive configuration for any application.

Column packing in a SNAP® Our column packing service provides fast turnaround times and delivers even greater ease of use combined with all of the features and benefits of using SNAP® columns.

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Evolve® Bioprocess Columns Ready-to-use bioprocess columns which deliver cost effective, scalable technology to support bioprocess downstream applications.

• Available in 70, 100, 140, 200, 250, 350, 450 & 600 mm diameters, with scalable performance throughout the range • 4 bar pressure rating with efficient flow distribution capable of flow rates up to 1000 cm/h • Easy to use & low maintenance • Pharmaceutical grade acrylic column conforms to FDA & USP VI requirements • Corrosion resistant, non-metallic flow path compatible with an extensive range of chemicals • Supplied with operating manual, tool kit and accessories • A wide range of accessories are also available to support your process needs

The proprietary design of the Evolve® column range allows for the use of column renewal/ refresh kits to replace the wetted flow path, saving both time and money while eliminating the risk of contamination between uses.

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Evolve® & SNAP® Accessories Evolve® Column Renewal/Refresh Kit • An easy and economical complete replacement of the wetted flow path of your Evolve® Column • Prevent cross contamination and negate the need to prove clearance of previous product & validation • Significant cost savings in comparison to purchasing a complete new column

The kit includes all parts and accessories required to efficiently replace the wetted components of your Evolve® Column, along with an extensive operating manual.

SNAP® Column Stands & Carts Our column stands and carts are designed to seamlessly fit into your lab. Constructed of chemically resistant aluminum, both storage solutions can accommodate column diameters up to 50 mm. The stands feature four levelling feet which remain level every time a new column is installed. Columns can be mounted on both sides of the cart to maximise storage capacity.

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Evolve®D, Evolve®R ® & Evolve S Pre-packed Evolve®D, Evolve®R, and Evolve®S ranges provide convenient, ready-to-use chromatography solutions which plug straight into your process.

Available in diameters up to 20 cm, Evolve®D columns are supplied pre-packed with media from Astrea Bioseparations’ range of products for applications such as protein purification & contaminant removal, and can be custom packed with most chromatography media types including agarose & polymethacrylate based adsorbents.

Evolve®R and Evolve®S pre-packed columns are available for process development and smaller scale applications.

Our pre-packed solutions span process development to small-scale manufacture and beyond, with scalable performance between column ranges.

Key Features • 4 bar pressure rating & flow rates achievable up to 1000 cm/h* • Non-metallic flow path eliminates corrosion risks from high salt and guanidine HCl solutions & prevents product inactivation through metal contact • Constructed of biocompatible materials conforming to FDA & USP VI requirements suitable for biopharmaceutical applications

Ready to Use • Evolve®D & Evolve®S columns are packed under ISO 7 conditions, and supplied fully qualified and certified. Regulatory Support File (RSF) available upon request.

• Evolve®R columns are supplied fully qualified, with CoA available upon request.

*empty column flow properties

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Small Scale Solutions Chromatography media developed by Astrea Bioseparations is available in ready-to-use formats for screening, scouting and process optimization experiments.

RoboColumns

1 mL & 5 mL Column kits

Efficient column format, delivering rapid & representative results in minimal time.

Constructed of biocompatible polypropylene casing, providing a cost effective and robust platform suitable for applications including: • Rapid one step & preparative purification • Small scale screening & scouting experiments • Downstream process development & optimisation • Contaminant removal Columns can be connected in series for increased capacity, and reused with adsorbent specific CIP/ equilibration protocols.

Compatible for use with liquid chromatography instruments, peristaltic pumps and syringes.

Supplied as a row of eight pre-packed columns in volumes of 200 µL and designed for use with automated robotic liquid handling systems to support applications including: • High-throughput screening • Process development & optimization • Scale-down experimental work

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At a glance Bioseparation Products

Our high performance bioseparations products and technologies are suitable for an extensive range of applications.

Contaminant Removal

Recombinant Proteins

Nereus LentiHERO® Albumin Fusion Proteins Albumin

AlbuPure® Aminophenylboronate P6XL

Glycoproteins Glycated Proteins Serine Proteases

Glycoproteins Glycated Proteins Serine Proteases

Butyl, Hexyl, Phenyl & Octyl PuraBead® 6HF (HIC)

mAb Dimer

mAb Bispecific Antibodies Antibody-Drug Conjugates

mAb Aggregates

mAb Bispecific Antibodies

DEAE, CM, Q & SP PuraBead® 6HF (IEX)

EtoxiClear®

Endotoxin Antibody Fragments Bispecific Antibodies

Fabsorbent™ F1P HF HCPure™

Host Cell Proteins Insulin Insulin Analogues

Insulin Adsorbent IsoClear A™ & B™

Isoagglutinins

Mimetic Blue® SA P6HF

Recombinant Albumin

Mimetic Blue® SA HL P6XL

Recombinant Albumin

Mimetic Blue® AP HL P6HF

Alkaline Phosphatase

MAbsorbent® A2P HF MAbsorbent® A2P HF LL P-Aminobenzamidine A6XL PE PuraBead® 6HF Evolve® Columns Evolve®D Columns Evolve®R & Evolve®S RoboColumns® SNAP® Columns

Serine Proteases Serine Esterases Phosphate Binding Proteins

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Bulk Adsorbent Gel Slurry

Pre-Packed Columns

From bench scale to process scale, Astrea Bioseparations’ in-house adsorbent manufacturing capacity has the capability to meet the requirements of the largest biomanufacturing processes.

A range of pre-packed column sizes are available, from 200 µL up to over 6 L.

Cell & Gene Therapy

Plasma Fractionation

Bioprocess Optimization

Albumin Fusion Proteins Albumin

Albumin Fusion Proteins Albumin

Lentivirus

Glycoproteins Glycated Proteins Serine Proteases AAV ocDNA scDNA

A1AT Fibrinogen

General Capture & Polish

AAV Lentivirus Exosomes pDNA siRNA

Plasminogen

General Capture & Polish

Endotoxin Antibody Fragments Host Cell Proteins Insulin Insulin Analogues Isoagglutinins Human Serum Albumin

Recombinant Albumin Human Serum Albumin

Human Serum Albumin

Recombinant Albumin Human Serum Albumin

IgG

IgG

IgG

IgG Serine Proteases Serine Esterases

Available in diameters up to 60 cm Available in diameters up to 20 cm 5 mL & 50 mL 200 µL Available in diameters up to 5 cm

+44 (0) 1223 433 800 | astreabioseparations.com sales@astrea-bio.com | techsupport@astrea-bio.com | quality@astrea-bio.com Global bases in North America, Canada and Cambridge UK HQ: Horizon Park, Barton Road, Comberton, Cambridge, CB23 7AJ, UK

Astrea Product Guide - V3 The Products are covered by or for use under one or more patents: www.astreabioseparations.com/patents AlbuPure® is a registered trademark of Albumedix Ltd. RoboColumns are packed by, and RoboColumn® is a trademark of Repligen GmbH. All other trademarks, trade names, trade dress, product names and logos appearing in this brochure are the property of Astrea UK Services Ltd. Copyright © 2024 Astrea Bioseparations Ltd. All rights reserved.